rationale of the study in research proposal example

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How to Write the Rationale of the Study in Research (Examples)

What is the Rationale of the Study?

The rationale of the study is the justification for taking on a given study. It explains the reason the study was conducted or should be conducted. This means the study rationale should explain to the reader or examiner why the study is/was necessary. It is also sometimes called the “purpose” or “justification” of a study. While this is not difficult to grasp in itself, you might wonder how the rationale of the study is different from your research question or from the statement of the problem of your study, and how it fits into the rest of your thesis or research paper. 

The rationale of the study links the background of the study to your specific research question and justifies the need for the latter on the basis of the former. In brief, you first provide and discuss existing data on the topic, and then you tell the reader, based on the background evidence you just presented, where you identified gaps or issues and why you think it is important to address those. The problem statement, lastly, is the formulation of the specific research question you choose to investigate, following logically from your rationale, and the approach you are planning to use to do that.

Table of Contents:

How to write a rationale for a research paper , how do you justify the need for a research study.

• Study Rationale Example: Where Does It Go In Your Paper?

The basis for writing a research rationale is preliminary data or a clear description of an observation. If you are doing basic/theoretical research, then a literature review will help you identify gaps in current knowledge. In applied/practical research, you base your rationale on an existing issue with a certain process (e.g., vaccine proof registration) or practice (e.g., patient treatment) that is well documented and needs to be addressed. By presenting the reader with earlier evidence or observations, you can (and have to) convince them that you are not just repeating what other people have already done or said and that your ideas are not coming out of thin air. 

Once you have explained where you are coming from, you should justify the need for doing additional research–this is essentially the rationale of your study. Finally, when you have convinced the reader of the purpose of your work, you can end your introduction section with the statement of the problem of your research that contains clear aims and objectives and also briefly describes (and justifies) your methodological approach. 

When is the Rationale for Research Written?

The author can present the study rationale both before and after the research is conducted. 

• Before conducting research : The study rationale is a central component of the research proposal . It represents the plan of your work, constructed before the study is actually executed.
• Once research has been conducted : After the study is completed, the rationale is presented in a research article or  PhD dissertation  to explain why you focused on this specific research question. When writing the study rationale for this purpose, the author should link the rationale of the research to the aims and outcomes of the study.

What to Include in the Study Rationale

Although every study rationale is different and discusses different specific elements of a study’s method or approach, there are some elements that should be included to write a good rationale. Make sure to touch on the following:

• A summary of conclusions from your review of the relevant literature
• What is currently unknown (gaps in knowledge)
• Inconclusive or contested results  from previous studies on the same or similar topic
• The necessity to improve or build on previous research, such as to improve methodology or utilize newer techniques and/or technologies

There are different types of limitations that you can use to justify the need for your study. In applied/practical research, the justification for investigating something is always that an existing process/practice has a problem or is not satisfactory. Let’s say, for example, that people in a certain country/city/community commonly complain about hospital care on weekends (not enough staff, not enough attention, no decisions being made), but you looked into it and realized that nobody ever investigated whether these perceived problems are actually based on objective shortages/non-availabilities of care or whether the lower numbers of patients who are treated during weekends are commensurate with the provided services.

In this case, “lack of data” is your justification for digging deeper into the problem. Or, if it is obvious that there is a shortage of staff and provided services on weekends, you could decide to investigate which of the usual procedures are skipped during weekends as a result and what the negative consequences are. 

In basic/theoretical research, lack of knowledge is of course a common and accepted justification for additional research—but make sure that it is not your only motivation. “Nobody has ever done this” is only a convincing reason for a study if you explain to the reader why you think we should know more about this specific phenomenon. If there is earlier research but you think it has limitations, then those can usually be classified into “methodological”, “contextual”, and “conceptual” limitations. To identify such limitations, you can ask specific questions and let those questions guide you when you explain to the reader why your study was necessary:

Methodological limitations

• Did earlier studies try but failed to measure/identify a specific phenomenon?
• Was earlier research based on incorrect conceptualizations of variables?
• Were earlier studies based on questionable operationalizations of key concepts?
• Did earlier studies use questionable or inappropriate research designs?

Contextual limitations

• Have recent changes in the studied problem made previous studies irrelevant?
• Are you studying a new/particular context that previous findings do not apply to?

Conceptual limitations

• Do previous findings only make sense within a specific framework or ideology?

Study Rationale Examples

Let’s look at an example from one of our earlier articles on the statement of the problem to clarify how your rationale fits into your introduction section. This is a very short introduction for a practical research study on the challenges of online learning. Your introduction might be much longer (especially the context/background section), and this example does not contain any sources (which you will have to provide for all claims you make and all earlier studies you cite)—but please pay attention to how the background presentation , rationale, and problem statement blend into each other in a logical way so that the reader can follow and has no reason to question your motivation or the foundation of your research.

Background presentation

Since the beginning of the Covid pandemic, most educational institutions around the world have transitioned to a fully online study model, at least during peak times of infections and social distancing measures. This transition has not been easy and even two years into the pandemic, problems with online teaching and studying persist (reference needed) . 

While the increasing gap between those with access to technology and equipment and those without access has been determined to be one of the main challenges (reference needed) , others claim that online learning offers more opportunities for many students by breaking down barriers of location and distance (reference needed) .  

Rationale of the study

Since teachers and students cannot wait for circumstances to go back to normal, the measures that schools and universities have implemented during the last two years, their advantages and disadvantages, and the impact of those measures on students’ progress, satisfaction, and well-being need to be understood so that improvements can be made and demographics that have been left behind can receive the support they need as soon as possible.

Statement of the problem

To identify what changes in the learning environment were considered the most challenging and how those changes relate to a variety of student outcome measures, we conducted surveys and interviews among teachers and students at ten institutions of higher education in four different major cities, two in the US (New York and Chicago), one in South Korea (Seoul), and one in the UK (London). Responses were analyzed with a focus on different student demographics and how they might have been affected differently by the current situation.

How long is a study rationale?

In a research article bound for journal publication, your rationale should not be longer than a few sentences (no longer than one brief paragraph). A  dissertation or thesis  usually allows for a longer description; depending on the length and nature of your document, this could be up to a couple of paragraphs in length. A completely novel or unconventional approach might warrant a longer and more detailed justification than an approach that slightly deviates from well-established methods and approaches.

Consider Using Professional Academic Editing Services

Now that you know how to write the rationale of the study for a research proposal or paper, you should make use of our free AI grammar checker , Wordvice AI, or receive professional academic proofreading services from Wordvice, including research paper editing services and manuscript editing services to polish your submitted research documents.

You can also find many more articles, for example on writing the other parts of your research paper , on choosing a title , or on making sure you understand and adhere to the author instructions before you submit to a journal, on the Wordvice academic resources pages.

How to Write the Rationale for a Research Paper

• Research Process
• Peer Review

A research rationale answers the big SO WHAT? that every adviser, peer reviewer, and editor has in mind when they critique your work. A compelling research rationale increases the chances of your paper being published or your grant proposal being funded. In this article, we look at the purpose of a research rationale, its components and key characteristics, and how to create an effective research rationale.

Updated on September 19, 2022

The rationale for your research is the reason why you decided to conduct the study in the first place. The motivation for asking the question. The knowledge gap. This is often the most significant part of your publication. It justifies the study's purpose, novelty, and significance for science or society. It's a critical part of standard research articles as well as funding proposals.

Essentially, the research rationale answers the big SO WHAT? that every (good) adviser, peer reviewer, and editor has in mind when they critique your work.

A compelling research rationale increases the chances of your paper being published or your grant proposal being funded. In this article, we look at:

• the purpose of a research rationale
• its components and key characteristics
• how to create an effective research rationale

What is a research rationale?

Think of a research rationale as a set of reasons that explain why a study is necessary and important based on its background. It's also known as the justification of the study, rationale, or thesis statement.

Essentially, you want to convince your reader that you're not reciting what other people have already said and that your opinion hasn't appeared out of thin air. You've done the background reading and identified a knowledge gap that this rationale now explains.

A research rationale is usually written toward the end of the introduction. You'll see this section clearly in high-impact-factor international journals like Nature and Science. At the end of the introduction there's always a phrase that begins with something like, "here we show..." or "in this paper we show..." This text is part of a logical sequence of information, typically (but not necessarily) provided in this order:

Here's an example from a study by Cataldo et al. (2021) on the impact of social media on teenagers' lives.

Note how the research background, gap, rationale, and objectives logically blend into each other.

The authors chose to put the research aims before the rationale. This is not a problem though. They still achieve a logical sequence. This helps the reader follow their thinking and convinces them about their research's foundation.

Elements of a research rationale

We saw that the research rationale follows logically from the research background and literature review/observation and leads into your study's aims and objectives.

This might sound somewhat abstract. A helpful way to formulate a research rationale is to answer the question, “Why is this study necessary and important?”

Generally, that something has never been done before should not be your only motivation. Use it only If you can give the reader valid evidence why we should learn more about this specific phenomenon.

A well-written introduction covers three key elements:

• What's the background to the research?
• What has been done before (information relevant to this particular study, but NOT a literature review)?
• Research rationale

Now, let's see how you might answer the question.

1. This study complements scientific knowledge and understanding

Discuss the shortcomings of previous studies and explain how'll correct them. Your short review can identify:

• Methodological limitations . The methodology (research design, research approach or sampling) employed in previous works is somewhat flawed.

Example : Here , the authors claim that previous studies have failed to explore the role of apathy “as a predictor of functional decline in healthy older adults” (Burhan et al., 2021). At the same time, we know a lot about other age-related neuropsychiatric disorders, like depression.

Their study is necessary, then, “to increase our understanding of the cognitive, clinical, and neural correlates of apathy and deconstruct its underlying mechanisms.” (Burhan et al., 2021).

• Contextual limitations . External factors have changed and this has minimized or removed the relevance of previous research.

Example : You want to do an empirical study to evaluate the effects of the COVID-19 pandemic on the number of tourists visiting Sicily. Previous studies might have measured tourism determinants in Sicily, but they preceded COVID-19.

• Conceptual limitations . Previous studies are too bound to a specific ideology or a theoretical framework.

Example : The work of English novelist E. M. Forster has been extensively researched for its social, political, and aesthetic dimensions. After the 1990s, younger scholars wanted to read his novels as an example of gay fiction. They justified the need to do so based on previous studies' reliance on homophobic ideology.

This kind of rationale is most common in basic/theoretical research.

2. This study can help solve a specific problem

Here, you base your rationale on a process that has a problem or is not satisfactory.

For example, patients complain about low-quality hospital care on weekends (staff shortages, inadequate attention, etc.). No one has looked into this (there is a lack of data). So, you explore if the reported problems are true and what can be done to address them. This is a knowledge gap.

Or you set out to explore a specific practice. You might want to study the pros and cons of several entry strategies into the Japanese food market.

It's vital to explain the problem in detail and stress the practical benefits of its solution. In the first example, the practical implications are recommendations to improve healthcare provision.

In the second example, the impact of your research is to inform the decision-making of businesses wanting to enter the Japanese food market.

This kind of rationale is more common in applied/practical research.

3. You're the best person to conduct this study

It's a bonus if you can show that you're uniquely positioned to deliver this study, especially if you're writing a funding proposal .

For an anthropologist wanting to explore gender norms in Ethiopia, this could be that they speak Amharic (Ethiopia's official language) and have already lived in the country for a few years (ethnographic experience).

Or if you want to conduct an interdisciplinary research project, consider partnering up with collaborators whose expertise complements your own. Scientists from different fields might bring different skills and a fresh perspective or have access to the latest tech and equipment. Teaming up with reputable collaborators justifies the need for a study by increasing its credibility and likely impact.

When is the research rationale written?

You can write your research rationale before, or after, conducting the study.

In the first case, when you might have a new research idea, and you're applying for funding to implement it.

Or you're preparing a call for papers for a journal special issue or a conference. Here , for instance, the authors seek to collect studies on the impact of apathy on age-related neuropsychiatric disorders.

In the second case, you have completed the study and are writing a research paper for publication. Looking back, you explain why you did the study in question and how it worked out.

Although the research rationale is part of the introduction, it's best to write it at the end. Stand back from your study and look at it in the big picture. At this point, it's easier to convince your reader why your study was both necessary and important.

How long should a research rationale be?

The length of the research rationale is not fixed. Ideally, this will be determined by the guidelines (of your journal, sponsor etc.).

The prestigious journal Nature , for instance, calls for articles to be no more than 6 or 8 pages, depending on the content. The introduction should be around 200 words, and, as mentioned, two to three sentences serve as a brief account of the background and rationale of the study, and come at the end of the introduction.

If you're not provided guidelines, consider these factors:

• Research document : In a thesis or book-length study, the research rationale will be longer than in a journal article. For example, the background and rationale of this book exploring the collective memory of World War I cover more than ten pages.
• Research question : Research into a new sub-field may call for a longer or more detailed justification than a study that plugs a gap in literature.

Which verb tenses to use in the research rationale?

It's best to use the present tense. Though in a research proposal, the research rationale is likely written in the future tense, as you're describing the intended or expected outcomes of the research project (the gaps it will fill, the problems it will solve).

Example of a research rationale

Research question : What are the teachers' perceptions of how a sense of European identity is developed and what underlies such perceptions?

Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology , 3(2), 77-101.

Burhan, A.M., Yang, J., & Inagawa, T. (2021). Impact of apathy on aging and age-related neuropsychiatric disorders. Research Topic. Frontiers in Psychiatry

Cataldo, I., Lepri, B., Neoh, M. J. Y., & Esposito, G. (2021). Social media usage and development of psychiatric disorders in childhood and adolescence: A review. Frontiers in Psychiatry , 11.

CiCe Jean Monnet Network (2017). Guidelines for citizenship education in school: Identities and European citizenship children's identity and citizenship in Europe.

Cohen, l, Manion, L., & Morrison, K. (2018). Research methods in education . Eighth edition. London: Routledge.

de Prat, R. C. (2013). Euroscepticism, Europhobia and Eurocriticism: The radical parties of the right and left “vis-à-vis” the European Union P.I.E-Peter Lang S.A., Éditions Scientifiques Internationales.

European Commission. (2017). Eurydice Brief: Citizenship education at school in Europe.

Polyakova, A., & Fligstein, N. (2016). Is European integration causing Europe to become more nationalist? Evidence from the 2007–9 financial crisis. Journal of European Public Policy , 23(1), 60-83.

Winter, J. (2014). Sites of Memory, Sites of Mourning: The Great War in European Cultural History . Cambridge: Cambridge University Press.

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Setting Rationale in Research: Cracking the code for excelling at research

Knowledge and curiosity lays the foundation of scientific progress. The quest for knowledge has always been a timeless endeavor. Scholars seek reasons to explain the phenomena they observe, paving way for development of research. Every investigation should offer clarity and a well-defined rationale in research is a cornerstone upon which the entire study can be built.

Research rationale is the heartbeat of every academic pursuit as it guides the researchers to unlock the untouched areas of their field. Additionally, it illuminates the gaps in the existing knowledge, and identifies the potential contributions that the study aims to make.

Table of Contents

What Is Research Rationale and When Is It Written

Research rationale is the “why” behind every academic research. It not only frames the study but also outlines its objectives , questions, and expected outcomes. Additionally, it helps to identify the potential limitations of the study . It serves as a lighthouse for researchers that guides through data collection and analysis, ensuring their efforts remain focused and purposeful. Typically, a rationale is written at the beginning of the research proposal or research paper . It is an essential component of the introduction section and provides the foundation for the entire study. Furthermore, it provides a clear understanding of the purpose and significance of the research to the readers before delving into the specific details of the study. In some cases, the rationale is written before the methodology, data analysis, and other sections. Also, it serves as the justification for the research, and how it contributes to the field. Defining a research rationale can help a researcher in following ways:

1. Justification of a Research Problem

• Research rationale helps to understand the essence of a research problem.
• It designs the right approach to solve a problem. This aspect is particularly important for applied research, where the outcomes can have real-world relevance and impact.
• Also, it explains why the study is worth conducting and why resources should be allocated to pursue it.
• Additionally, it guides a researcher to highlight the benefits and implications of a strategy.

2. Elimination of Literature Gap

• Research rationale helps to ideate new topics which are less addressed.
• Additionally, it offers fresh perspectives on existing research and discusses the shortcomings in previous studies.
• It shows that your study aims to contribute to filling these gaps and advancing the field’s understanding.

3. Originality and Novelty

• The rationale highlights the unique aspects of your research and how it differs from previous studies.
• Furthermore, it explains why your research adds something new to the field and how it expands upon existing knowledge.
• It highlights how your findings might contribute to a better understanding of a particular issue or problem and potentially lead to positive changes.
• Besides these benefits, it provides a personal motivation to the researchers. In some cases, researchers might have personal experiences or interests that drive their desire to investigate a particular topic.

4. An Increase in Chances of Funding

• It is essential to convince funding agencies , supervisors, or reviewers, that a research is worth pursuing.
• Therefore, a good rationale can get your research approved for funding and increases your chances of getting published in journals; as it addresses the potential knowledge gap in existing research.

Overall, research rationale is essential for providing a clear and convincing argument for the value and importance of your research study, setting the stage for the rest of the research proposal or manuscript. Furthermore, it helps establish the context for your work and enables others to understand the purpose and potential impact of your research.

5 Key Elements of a Research Rationale

Research rationale must include certain components which make it more impactful. Here are the key elements of a research rationale:

By incorporating these elements, you provide a strong and convincing case for the legitimacy of your research, which is essential for gaining support and approval from academic institutions, funding agencies, or other stakeholders.

How to Write a Rationale in Research

Writing a rationale requires careful consideration of the reasons for conducting the study. It is usually written in the present tense.

Here are some steps to guide you through the process of writing a research rationale:

After writing the initial draft, it is essential to review and revise the research rationale to ensure that it effectively communicates the purpose of your research. The research rationale should be persuasive and compelling, convincing readers that your study is worthwhile and deserves their attention.

How Long Should a Research Rationale be?

Although there is no pre-defined length for a rationale in research, its length may vary depending on the specific requirements of the research project. It also depends on the academic institution or organization, and the guidelines set by the research advisor or funding agency. In general, a research rationale is usually a concise and focused document.

Typically, it ranges from a few paragraphs to a few pages, but it is usually recommended to keep it as crisp as possible while ensuring all the essential elements are adequately covered. The length of a research rationale can be roughly as follows:

1. For Research Proposal:

A. Around 1 to 3 pages

B. Ensure clear and comprehensive explanation of the research question, its significance, literature review , and methodological approach.

2. Thesis or Dissertation:

A. Around 3 to 5 pages

B. Ensure an extensive coverage of the literature review, theoretical framework, and research objectives to provide a robust justification for the study.

3. Journal Article:

A. Usually concise. Ranges from few paragraphs to one page

B. The research rationale is typically included as part of the introduction section

However, remember that the quality and content of the research rationale are more important than its length. The reasons for conducting the research should be well-structured, clear, and persuasive when presented. Always adhere to the specific institution or publication guidelines.

Example of a Research Rationale

In conclusion, the research rationale serves as the cornerstone of a well-designed and successful research project. It ensures that research efforts are focused, meaningful, and ethically sound. Additionally, it provides a comprehensive and logical justification for embarking on a specific investigation. Therefore, by identifying research gaps, defining clear objectives, emphasizing significance, explaining the chosen methodology, addressing ethical considerations, and recognizing potential limitations, researchers can lay the groundwork for impactful and valuable contributions to the scientific community.

So, are you ready to delve deeper into the world of research and hone your academic writing skills? Explore Enago Academy ‘s comprehensive resources and courses to elevate your research and make a lasting impact in your field. Also, share your thoughts and experiences in the form of an article or a thought piece on Enago Academy’s Open Platform .

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Frequently Asked Questions

A rationale of the study can be written by including the following points: 1. Background of the Research/ Study 2. Identifying the Knowledge Gap 3. An Overview of the Goals and Objectives of the Study 4. Methodology and its Significance 5. Relevance of the Research

Start writing a research rationale by defining the research problem and discussing the literature gap associated with it.

A research rationale can be ended by discussing the expected results and summarizing the need of the study.

A rationale for thesis can be made by covering the following points: 1. Extensive coverage of the existing literature 2. Explaining the knowledge gap 3. Provide the framework and objectives of the study 4. Provide a robust justification for the study/ research 5. Highlight the potential of the research and the expected outcomes

A rationale for dissertation can be made by covering the following points: 1. Highlight the existing reference 2. Bridge the gap and establish the context of your research 3. Describe the problem and the objectives 4. Give an overview of the methodology

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Rationale for the Study

It is important for you to be able to explain the importance of the research you are conducting by providing valid arguments. Rationale for the study, also referred to as justification for the study, is reason why you have conducted your study in the first place. This part in your paper needs to explain uniqueness and importance of your research. Rationale for the study needs to be specific and ideally, it should relate to the following points:

1. The research needs to contribute to the elimination of a gap in the literature. Elimination of gap in the present literature is one of the compulsory requirements for your study. In other words, you don’t need to ‘re-invent the wheel’ and your research aims and objectives need to focus on new topics. For example, you can choose to conduct an empirical study to assess the implications of COVID-19 pandemic on the numbers of tourists visitors in your city. This might be previously undressed topic, taking into account that COVID-19 pandemic is a relatively recent phenomenon.

Alternatively, if you cannot find a new topic to research, you can attempt to offer fresh perspectives on existing management, business or economic issues. For example, while thousands of studies have been previously conducted to study various aspects of leadership, this topic as far from being exhausted as a research area. Specifically, new studies can be conducted in the area of leadership to analyze the impacts of new communication mediums such as TikTok, and other social networking sites on leadership practices.

You can also discuss the shortcomings of previous works devoted to your research area. Shortcomings in previous studies can be divided into three groups:

a) Methodological limitations . Methodology employed in previous study may be flawed in terms of research design, research approach or sampling.

b) Contextual limitations . Relevance of previous works may be non-existent for the present because external factors have changed.

c) Conceptual limitations . Previous studies may be unjustifiably bound up to a particular model or an ideology.

While discussing the shortcomings of previous studies you should explain how you are going to correct them. This principle is true to almost all areas in business studies i.e. gaps or shortcomings in the literature can be found in relation to almost all areas of business and economics.

2. The research can be conducted to solve a specific problem. It helps if you can explain why you are the right person and in the right position to solve the problem. You have to explain the essence of the problem in a detailed manner and highlight practical benefits associated with the solution of the problem. Suppose, your dissertation topic is “a study into advantages and disadvantages of various entry strategies into Chinese market”. In this case, you can say that practical implications of your research relates to assisting businesses aiming to enter Chinese market to do more informed decision making.

Alternatively, if your research is devoted to the analysis of impacts of CSR programs and initiatives on brand image, practical contributions of your study would relate to contributing to the level of effectiveness of CSR programs of businesses.

Additional examples of studies that can assist to address specific practical problems may include the following:

• A study into the reasons of high employee turnover at Hanson Brick
• A critical analysis of employee motivation problems at Esporta, Finchley Road, London
• A research into effective succession planning at Microsoft
• A study into major differences between private and public primary education in the USA and implications of these differences on the quality of education

However, it is important to note that it is not an obligatory for a dissertation   to be associated with the solution of a specific problem. Dissertations can be purely theory-based as well. Examples of such studies include the following:

• Born or bred: revising The Great Man theory of leadership in the 21 st century
• A critical analysis of the relevance of McClelland’s Achievement theory to the US information technology industry
• Neoliberalism as a major reason behind the emergence of the global financial and economic crisis of 2007-2009
• Analysis of Lewin’s Model of Change and its relevance to pharmaceutical sector of France

3. Your study has to contribute to the level of professional development of the researcher . That is you. You have to explain in a detailed manner in what ways your research contributes to the achievement of your long-term career aspirations.

For example, you have selected a research topic of “ A critical analysis of the relevance of McClelland’s Achievement theory in the US information technology industry ”.  You may state that you associate your career aspirations with becoming an IT executive in the US, and accordingly, in-depth knowledge of employee motivation in this industry is going to contribute your chances of success in your chosen career path.

Therefore, you are in a better position if you have already identified your career objectives, so that during the research process you can get detailed knowledge about various aspects of your chosen industry.

My e-book, The Ultimate Guide to Writing a Dissertation in Business Studies: a step by step assistance offers practical assistance to complete a dissertation with minimum or no stress. The e-book covers all stages of writing a dissertation starting from the selection to the research area to submitting the completed version of the work within the deadline.

John Dudovskiy

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The goal of a research proposal is twofold: to present and justify the need to study a research problem and to present the practical ways in which the proposed study should be conducted. The design elements and procedures for conducting research are governed by standards of the predominant discipline in which the problem resides, therefore, the guidelines for research proposals are more exacting and less formal than a general project proposal. Research proposals contain extensive literature reviews. They must provide persuasive evidence that a need exists for the proposed study. In addition to providing a rationale, a proposal describes detailed methodology for conducting the research consistent with requirements of the professional or academic field and a statement on anticipated outcomes and benefits derived from the study's completion.

Krathwohl, David R. How to Prepare a Dissertation Proposal: Suggestions for Students in Education and the Social and Behavioral Sciences . Syracuse, NY: Syracuse University Press, 2005.

How to Approach Writing a Research Proposal

Your professor may assign the task of writing a research proposal for the following reasons:

• Develop your skills in thinking about and designing a comprehensive research study;
• Learn how to conduct a comprehensive review of the literature to determine that the research problem has not been adequately addressed or has been answered ineffectively and, in so doing, become better at locating pertinent scholarship related to your topic;
• Improve your general research and writing skills;
• Practice identifying the logical steps that must be taken to accomplish one's research goals;
• Critically review, examine, and consider the use of different methods for gathering and analyzing data related to the research problem; and,
• Nurture a sense of inquisitiveness within yourself and to help see yourself as an active participant in the process of conducting scholarly research.

A proposal should contain all the key elements involved in designing a completed research study, with sufficient information that allows readers to assess the validity and usefulness of your proposed study. The only elements missing from a research proposal are the findings of the study and your analysis of those findings. Finally, an effective proposal is judged on the quality of your writing and, therefore, it is important that your proposal is coherent, clear, and compelling.

Regardless of the research problem you are investigating and the methodology you choose, all research proposals must address the following questions:

• What do you plan to accomplish? Be clear and succinct in defining the research problem and what it is you are proposing to investigate.
• Why do you want to do the research? In addition to detailing your research design, you also must conduct a thorough review of the literature and provide convincing evidence that it is a topic worthy of in-depth study. A successful research proposal must answer the "So What?" question.
• How are you going to conduct the research? Be sure that what you propose is doable. If you're having difficulty formulating a research problem to propose investigating, go here for strategies in developing a problem to study.

Common Mistakes to Avoid

• Failure to be concise . A research proposal must be focused and not be "all over the map" or diverge into unrelated tangents without a clear sense of purpose.
• Failure to cite landmark works in your literature review . Proposals should be grounded in foundational research that lays a foundation for understanding the development and scope of the the topic and its relevance.
• Failure to delimit the contextual scope of your research [e.g., time, place, people, etc.]. As with any research paper, your proposed study must inform the reader how and in what ways the study will frame the problem.
• Failure to develop a coherent and persuasive argument for the proposed research . This is critical. In many workplace settings, the research proposal is a formal document intended to argue for why a study should be funded.
• Sloppy or imprecise writing, or poor grammar . Although a research proposal does not represent a completed research study, there is still an expectation that it is well-written and follows the style and rules of good academic writing.
• Too much detail on minor issues, but not enough detail on major issues . Your proposal should focus on only a few key research questions in order to support the argument that the research needs to be conducted. Minor issues, even if valid, can be mentioned but they should not dominate the overall narrative.

Procter, Margaret. The Academic Proposal.  The Lab Report. University College Writing Centre. University of Toronto; Sanford, Keith. Information for Students: Writing a Research Proposal. Baylor University; Wong, Paul T. P. How to Write a Research Proposal. International Network on Personal Meaning. Trinity Western University; Writing Academic Proposals: Conferences, Articles, and Books. The Writing Lab and The OWL. Purdue University; Writing a Research Proposal. University Library. University of Illinois at Urbana-Champaign.

Structure and Writing Style

Beginning the Proposal Process

As with writing most college-level academic papers, research proposals are generally organized the same way throughout most social science disciplines. The text of proposals generally vary in length between ten and thirty-five pages, followed by the list of references. However, before you begin, read the assignment carefully and, if anything seems unclear, ask your professor whether there are any specific requirements for organizing and writing the proposal.

A good place to begin is to ask yourself a series of questions:

• What do I want to study?
• Why is the topic important?
• How is it significant within the subject areas covered in my class?
• What problems will it help solve?
• How does it build upon [and hopefully go beyond] research already conducted on the topic?
• What exactly should I plan to do, and can I get it done in the time available?

In general, a compelling research proposal should document your knowledge of the topic and demonstrate your enthusiasm for conducting the study. Approach it with the intention of leaving your readers feeling like, "Wow, that's an exciting idea and I can’t wait to see how it turns out!"

Most proposals should include the following sections:

I.  Introduction

In the real world of higher education, a research proposal is most often written by scholars seeking grant funding for a research project or it's the first step in getting approval to write a doctoral dissertation. Even if this is just a course assignment, treat your introduction as the initial pitch of an idea based on a thorough examination of the significance of a research problem. After reading the introduction, your readers should not only have an understanding of what you want to do, but they should also be able to gain a sense of your passion for the topic and to be excited about the study's possible outcomes. Note that most proposals do not include an abstract [summary] before the introduction.

Think about your introduction as a narrative written in two to four paragraphs that succinctly answers the following four questions :

• What is the central research problem?
• What is the topic of study related to that research problem?
• What methods should be used to analyze the research problem?
• Answer the "So What?" question by explaining why this is important research, what is its significance, and why should someone reading the proposal care about the outcomes of the proposed study?

II.  Background and Significance

This is where you explain the scope and context of your proposal and describe in detail why it's important. It can be melded into your introduction or you can create a separate section to help with the organization and narrative flow of your proposal. Approach writing this section with the thought that you can’t assume your readers will know as much about the research problem as you do. Note that this section is not an essay going over everything you have learned about the topic; instead, you must choose what is most relevant in explaining the aims of your research.

To that end, while there are no prescribed rules for establishing the significance of your proposed study, you should attempt to address some or all of the following:

• State the research problem and give a more detailed explanation about the purpose of the study than what you stated in the introduction. This is particularly important if the problem is complex or multifaceted .
• Present the rationale of your proposed study and clearly indicate why it is worth doing; be sure to answer the "So What? question [i.e., why should anyone care?].
• Describe the major issues or problems examined by your research. This can be in the form of questions to be addressed. Be sure to note how your proposed study builds on previous assumptions about the research problem.
• Explain the methods you plan to use for conducting your research. Clearly identify the key sources you intend to use and explain how they will contribute to your analysis of the topic.
• Describe the boundaries of your proposed research in order to provide a clear focus. Where appropriate, state not only what you plan to study, but what aspects of the research problem will be excluded from the study.
• If necessary, provide definitions of key concepts, theories, or terms.

III.  Literature Review

Connected to the background and significance of your study is a section of your proposal devoted to a more deliberate review and synthesis of prior studies related to the research problem under investigation . The purpose here is to place your project within the larger whole of what is currently being explored, while at the same time, demonstrating to your readers that your work is original and innovative. Think about what questions other researchers have asked, what methodological approaches they have used, and what is your understanding of their findings and, when stated, their recommendations. Also pay attention to any suggestions for further research.

Since a literature review is information dense, it is crucial that this section is intelligently structured to enable a reader to grasp the key arguments underpinning your proposed study in relation to the arguments put forth by other researchers. A good strategy is to break the literature into "conceptual categories" [themes] rather than systematically or chronologically describing groups of materials one at a time. Note that conceptual categories generally reveal themselves after you have read most of the pertinent literature on your topic so adding new categories is an on-going process of discovery as you review more studies. How do you know you've covered the key conceptual categories underlying the research literature? Generally, you can have confidence that all of the significant conceptual categories have been identified if you start to see repetition in the conclusions or recommendations that are being made.

NOTE: Do not shy away from challenging the conclusions made in prior research as a basis for supporting the need for your proposal. Assess what you believe is missing and state how previous research has failed to adequately examine the issue that your study addresses. Highlighting the problematic conclusions strengthens your proposal. For more information on writing literature reviews, GO HERE .

To help frame your proposal's review of prior research, consider the "five C’s" of writing a literature review:

• Cite , so as to keep the primary focus on the literature pertinent to your research problem.
• Compare the various arguments, theories, methodologies, and findings expressed in the literature: what do the authors agree on? Who applies similar approaches to analyzing the research problem?
• Contrast the various arguments, themes, methodologies, approaches, and controversies expressed in the literature: describe what are the major areas of disagreement, controversy, or debate among scholars?
• Critique the literature: Which arguments are more persuasive, and why? Which approaches, findings, and methodologies seem most reliable, valid, or appropriate, and why? Pay attention to the verbs you use to describe what an author says/does [e.g., asserts, demonstrates, argues, etc.].
• Connect the literature to your own area of research and investigation: how does your own work draw upon, depart from, synthesize, or add a new perspective to what has been said in the literature?

IV.  Research Design and Methods

This section must be well-written and logically organized because you are not actually doing the research, yet, your reader must have confidence that you have a plan worth pursuing . The reader will never have a study outcome from which to evaluate whether your methodological choices were the correct ones. Thus, the objective here is to convince the reader that your overall research design and proposed methods of analysis will correctly address the problem and that the methods will provide the means to effectively interpret the potential results. Your design and methods should be unmistakably tied to the specific aims of your study.

Describe the overall research design by building upon and drawing examples from your review of the literature. Consider not only methods that other researchers have used, but methods of data gathering that have not been used but perhaps could be. Be specific about the methodological approaches you plan to undertake to obtain information, the techniques you would use to analyze the data, and the tests of external validity to which you commit yourself [i.e., the trustworthiness by which you can generalize from your study to other people, places, events, and/or periods of time].

When describing the methods you will use, be sure to cover the following:

• Specify the research process you will undertake and the way you will interpret the results obtained in relation to the research problem. Don't just describe what you intend to achieve from applying the methods you choose, but state how you will spend your time while applying these methods [e.g., coding text from interviews to find statements about the need to change school curriculum; running a regression to determine if there is a relationship between campaign advertising on social media sites and election outcomes in Europe ].
• Keep in mind that the methodology is not just a list of tasks; it is a deliberate argument as to why techniques for gathering information add up to the best way to investigate the research problem. This is an important point because the mere listing of tasks to be performed does not demonstrate that, collectively, they effectively address the research problem. Be sure you clearly explain this.
• Anticipate and acknowledge any potential barriers and pitfalls in carrying out your research design and explain how you plan to address them. No method applied to research in the social and behavioral sciences is perfect, so you need to describe where you believe challenges may exist in obtaining data or accessing information. It's always better to acknowledge this than to have it brought up by your professor!

V.  Preliminary Suppositions and Implications

Just because you don't have to actually conduct the study and analyze the results, doesn't mean you can skip talking about the analytical process and potential implications . The purpose of this section is to argue how and in what ways you believe your research will refine, revise, or extend existing knowledge in the subject area under investigation. Depending on the aims and objectives of your study, describe how the anticipated results will impact future scholarly research, theory, practice, forms of interventions, or policy making. Note that such discussions may have either substantive [a potential new policy], theoretical [a potential new understanding], or methodological [a potential new way of analyzing] significance.   When thinking about the potential implications of your study, ask the following questions:

• What might the results mean in regards to challenging the theoretical framework and underlying assumptions that support the study?
• What suggestions for subsequent research could arise from the potential outcomes of the study?
• What will the results mean to practitioners in the natural settings of their workplace, organization, or community?
• Will the results influence programs, methods, and/or forms of intervention?
• How might the results contribute to the solution of social, economic, or other types of problems?
• Will the results influence policy decisions?
• In what way do individuals or groups benefit should your study be pursued?
• What will be improved or changed as a result of the proposed research?
• How will the results of the study be implemented and what innovations or transformative insights could emerge from the process of implementation?

NOTE:   This section should not delve into idle speculation, opinion, or be formulated on the basis of unclear evidence . The purpose is to reflect upon gaps or understudied areas of the current literature and describe how your proposed research contributes to a new understanding of the research problem should the study be implemented as designed.

ANOTHER NOTE : This section is also where you describe any potential limitations to your proposed study. While it is impossible to highlight all potential limitations because the study has yet to be conducted, you still must tell the reader where and in what form impediments may arise and how you plan to address them.

VI.  Conclusion

The conclusion reiterates the importance or significance of your proposal and provides a brief summary of the entire study . This section should be only one or two paragraphs long, emphasizing why the research problem is worth investigating, why your research study is unique, and how it should advance existing knowledge.

Someone reading this section should come away with an understanding of:

• Why the study should be done;
• The specific purpose of the study and the research questions it attempts to answer;
• The decision for why the research design and methods used where chosen over other options;
• The potential implications emerging from your proposed study of the research problem; and
• A sense of how your study fits within the broader scholarship about the research problem.

VII.  Citations

As with any scholarly research paper, you must cite the sources you used . In a standard research proposal, this section can take two forms, so consult with your professor about which one is preferred.

• References -- a list of only the sources you actually used in creating your proposal.
• Bibliography -- a list of everything you used in creating your proposal, along with additional citations to any key sources relevant to understanding the research problem.

In either case, this section should testify to the fact that you did enough preparatory work to ensure the project will complement and not just duplicate the efforts of other researchers. It demonstrates to the reader that you have a thorough understanding of prior research on the topic.

Most proposal formats have you start a new page and use the heading "References" or "Bibliography" centered at the top of the page. Cited works should always use a standard format that follows the writing style advised by the discipline of your course [e.g., education=APA; history=Chicago] or that is preferred by your professor. This section normally does not count towards the total page length of your research proposal.

Develop a Research Proposal: Writing the Proposal. Office of Library Information Services. Baltimore County Public Schools; Heath, M. Teresa Pereira and Caroline Tynan. “Crafting a Research Proposal.” The Marketing Review 10 (Summer 2010): 147-168; Jones, Mark. “Writing a Research Proposal.” In MasterClass in Geography Education: Transforming Teaching and Learning . Graham Butt, editor. (New York: Bloomsbury Academic, 2015), pp. 113-127; Juni, Muhamad Hanafiah. “Writing a Research Proposal.” International Journal of Public Health and Clinical Sciences 1 (September/October 2014): 229-240; Krathwohl, David R. How to Prepare a Dissertation Proposal: Suggestions for Students in Education and the Social and Behavioral Sciences . Syracuse, NY: Syracuse University Press, 2005; Procter, Margaret. The Academic Proposal. The Lab Report. University College Writing Centre. University of Toronto; Punch, Keith and Wayne McGowan. "Developing and Writing a Research Proposal." In From Postgraduate to Social Scientist: A Guide to Key Skills . Nigel Gilbert, ed. (Thousand Oaks, CA: Sage, 2006), 59-81; Wong, Paul T. P. How to Write a Research Proposal. International Network on Personal Meaning. Trinity Western University; Writing Academic Proposals: Conferences , Articles, and Books. The Writing Lab and The OWL. Purdue University; Writing a Research Proposal. University Library. University of Illinois at Urbana-Champaign.

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How to Write a Rationale: A Guide for Research and Beyond

Ever found yourself scratching your head, wondering how to justify your choice of a research topic or project? You’re not alone! Writing a rationale, which essentially means explaining the ‘why’ behind your decisions, is crucial to any research process. It’s like the secret sauce that adds flavour to your research recipe. So, the only thing you need to know is how to write a rationale.

What is a Rationale?

A rationale in research is essentially the foundation of your study. It serves as the justification for undertaking a particular research project. At its core, the rationale explains why the research was conducted or needs to be conducted, thus addressing a specific knowledge gap or research question.

Here’s a breakdown of the key elements involved in crafting a rationale:

Linking Background to Research Question: 

The rationale should connect the background of the study to your specific research question. It involves presenting and discussing existing data on your topic, identifying gaps or issues in the current understanding, and explaining why addressing them is important​.

Objectives and Significance: 

Your rationale should clearly outline your research objectives – what you hope to discover or achieve through the study. It should also emphasize the subject’s significance in your field and explain why more or better research is needed​.

Methodological Approach: 

The rationale should briefly describe your proposed research method , whether qualitative (descriptive) or quantitative (experimental), and justify this choice​.

Justifying the Need for Research: 

The rationale isn’t just about what you’re doing and why it’s necessary. It can involve highlighting methodological, contextual, or conceptual limitations in previous studies and explaining how your research aims to overcome these limitations. Essentially, you’re making a case for why your research fills a crucial gap in existing knowledge​​.

Presenting Before and After Research: 

Interestingly, the rationale can be presented before and after the research. Before the research, it forms a central part of the research proposal, setting out the plan for the work. After the research, it’s presented in a research article or dissertation to explain the focus on a specific research question and link it to the study’s aims and outcomes​.

Elements to Include: 

A good rationale should include a summary of conclusions from your literature review, identify what is currently unknown, discuss inconclusive or contested results from previous studies, and emphasize the necessity to improve or build on previous research​.

Creating a rationale is a vital part of the research process, as it not only sets the stage for your study but also convinces readers of the value and necessity of your work.

How to Write a Rationale:

Writing a rationale for your research is crucial in conducting and presenting your study. It involves explaining why your research is necessary and important. Here’s a guide to help you craft a compelling rationale:

Identify the Problem or Knowledge Gap: 

Begin by clearly stating the issue or gap in knowledge that your research aims to address. Explain why this problem is important and merits investigation. It is the foundation of your rationale and sets the stage for the need for your research.​

Review the Literature: 

Conduct a thorough review of existing literature on your topic. It helps you understand what research has already been done and what gaps or open questions exist. Your rationale should build on this background by highlighting these gaps and emphasizing the importance of addressing them​​​​.

Define Your Research Questions/Hypotheses: 

Based on your understanding of the problem and literature review, clearly state the research questions or hypotheses that your study aims to explore. These should logically stem from the identified gaps or issues.

Explain Your Research Approach: 

Describe the methods you will use for your research, including data collection and analysis techniques. Justify why these methods are appropriate for addressing your research questions or hypotheses​​.

Discuss the Potential Impact of Your Research:  Explain the significance of your study. Consider both theoretical contributions and practical implications. For instance, how does your research advance existing knowledge? Does it have real-world applications? Is it relevant to a specific field or community?​

Consider Ethical Considerations: 

If your research involves human or animal subjects, discuss the ethical aspects and how you plan to conduct your study responsibly​.

Contextualise Your Study: 

Justify the relevance of your research by explaining how it fits into the broader context. Connect your study to current trends, societal needs, or academic discussions​​.

Support with Evidence: 

Provide evidence or examples that underscore the need for your research. It could include citing relevant studies, statistics, or scenarios that illustrate the problem or gap your research addresses​.

Methodological, Contextual, and Conceptual Limitations: 

Address any limitations of previous research and how your study aims to overcome them. It can include methodological flaws in previous studies, changes in external factors that make past research less relevant, or the need to study a phenomenon within a new conceptual framework​.

Placement in Your Paper: 

Typically, the rationale is written toward the end of the introduction section of your paper, providing a logical lead-in to your research questions and methodology​​.

By following these steps and considering your audience’s perspective, you can write a strong and compelling rationale that clearly communicates the significance and necessity of your research project.

Frequently Asked Questions:

What makes a good research rationale.

A good rationale clearly identifies a gap in existing knowledge, builds on previous research, and outlines why your study is necessary and significant.

How detailed should my literature review be in the rationale?

Your literature review should be comprehensive enough to highlight the gaps your research aims to fill, but it should not overshadow the rationale itself.

Conclusion: 

A well-crafted rationale is your ticket to making your research stand out. It’s about bridging gaps, challenging norms, and paving the way for new discoveries. So go ahead, make your rationale the cornerstone of your research narrative!

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How to Write a Study Rationale

Last Updated: May 19, 2023 Fact Checked

This article was co-authored by Jake Adams and by wikiHow staff writer, Jennifer Mueller, JD . Jake Adams is an academic tutor and the owner of Simplifi EDU, a Santa Monica, California based online tutoring business offering learning resources and online tutors for academic subjects K-College, SAT & ACT prep, and college admissions applications. With over 14 years of professional tutoring experience, Jake is dedicated to providing his clients the very best online tutoring experience and access to a network of excellent undergraduate and graduate-level tutors from top colleges all over the nation. Jake holds a BS in International Business and Marketing from Pepperdine University. This article has been fact-checked, ensuring the accuracy of any cited facts and confirming the authority of its sources. This article has been viewed 56,038 times.

A study rationale explains the reason for a study and the importance of its findings for a particular field. Commonly, you'll need to write a study rationale as part of a university course of study, although you may also need to write one as a professional researcher to apply for funding or other support. As a student, your study rationale also justifies how it fulfills the requirements for your degree program or course of study. Do research before you write your study rationale so that you can discuss the previous work your study builds on and explain its significance to your field. Thorough research is also important in the professional context because your rationale will likely become part of the contract if funding or support is approved. [1] X Research source

Describing What You Hope to Accomplish

• For example, suppose you want to study how working the night shift affects the academic performance of college students who are taking classes during the day. A narrow question would measure a specific impact based on a specific amount of hours worked.

• Justify the methodology you're using. If there's another methodology that might accomplish the same result, describe it and explain why your methodology is superior — perhaps because it's more efficient, takes less time, or uses fewer resources. For example, you might get more information out of personal interviews, but creating an online questionnaire is more cost-effective.
• Particularly if you're seeking funding or support, this section of your rationale will also include details about the cost of your study and the facilities or resources you'll need. [3] X Research source

Tip: A methodology that is more complex, difficult, or expensive requires more justification than one that is straightforward and simple.

• For example, if you're studying the effect of working the night shift on academic performance, you might hypothesize that working 4 or more nights a week lowers students' grade point averages by more than 1 point.

• Use action words, such as "quantify" or "establish," when writing your goals. For example, you might write that one goal of your study is to "quantify the degree to which working at night inhibits the academic performance of college students."
• If you are a professional researcher, your objectives may need to be more specific and concrete. The organization you submit your rationale to will have details about the requirements to apply for funding and other support. [5] X Research source

Explaining Your Study's Significance

• Going into extensive detail usually isn't necessary. Instead, highlight the findings of the most significant work in the field that addressed a similar question.
• Provide references so that your readers can examine the previous studies for themselves and compare them to your proposed study.

• Methodological limitations: Previous studies failed to measure the variables appropriately or used a research design that had problems or biases
• Contextual limitations: Previous studies aren't relevant because circumstances have changed regarding the variables measured
• Conceptual limitations: Previous studies are too tied up in a specific ideology or framework

• For example, if a previous study had been conducted to support a university's policy that full-time students were not permitted to work, you might argue that it was too tied up in that specific ideology and that this biased the results. You could then point out that your study is not intended to advance any particular policy.

Tip: If you have to defend or present your rationale to an advisor or team, try to anticipate the questions they might ask you and include the answers to as many of those questions as possible.

Including Academic Proposal Information

• As a student, you might emphasize your major and specific classes you've taken that give you particular knowledge about the subject of your study. If you've served as a research assistant on a study with a similar methodology or covering a similar research question, you might mention that as well.
• If you're a professional researcher, focus on the experience you have in a particular field as well as the studies you've done in the past. If you have done studies with a similar methodology that were important in your field, you might mention those as well.

Tip: If you don't have any particular credentials or experience that are relevant to your study, tell the readers of your rationale what drew you to this particular topic and how you became interested in it.

• For example, if you are planning to conduct the study as fulfillment of the research requirement for your degree program, you might discuss any specific guidelines for that research requirement and list how your study meets those criteria.

• In most programs, there will be specific wording for you to include in your rationale if you're submitting it for a certain number of credits. Your instructor or advisor can help make sure you've worded this appropriately.

Study Rationale Outline and Example

Expert Q&A

• This article presents an overview of how to write a study rationale. Check with your instructor or advisor for any specific requirements that apply to your particular project. Thanks Helpful 0 Not Helpful 0

You Might Also Like

• ↑ https://research.com/research/how-to-write-research-methodology
• ↑ https://ris.leeds.ac.uk/applying-for-funding/developing-your-proposal/resources-and-tips/key-questions-for-researchers/
• ↑ https://www.cwauthors.com/article/how-to-write-the-rationale-for-your-research
• ↑ http://www.writingcentre.uct.ac.za/sites/default/files/image_tool/images/167/Rationale.pdf
• ↑ https://www.niaid.nih.gov/grants-contracts/write-research-plan
• ↑ https://www.esc.edu/degree-planning-academic-review/degree-program/student-degree-planning-guide/rationale-essay-writing/writing-tips/

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The rationale for one’s research is the justification for undertaking a given study. It states the reason(s) why a researcher chooses to focus on the topic in question, including what the significance is and what gaps the research intends to fill. In short, it is an explanation that rationalises the need for the study. The rationale is typically followed by a hypothesis/ research question (s) and the study objectives.

When is the rationale for research written?

The rationale of a study can be presented both before and after the research is conducted. 

• Before : The rationale is a crucial part of your research proposal , representing the plan of your work as formulated before you execute your study.
• After : Once the study is completed, the rationale is presented in a research paper or dissertation to explain why you focused on the particular question. In this instance, you would link the rationale of your research project to the study aims and outcomes.

Basis for writing the research rationale

The study rationale is predominantly based on preliminary data . A literature review will help you identify gaps in the current knowledge base and also ensure that you avoid duplicating what has already been done. You can then formulate the justification for your study from the existing literature on the subject and the perceived outcomes of the proposed study.

Length of the research rationale

In a research proposal or research article, the rationale would not take up more than a few sentences . A thesis or dissertation would allow for a longer description, which could even run into a couple of paragraphs . The length might even depend on the field of study or nature of the experiment. For instance, a completely novel or unconventional approach might warrant a longer and more detailed justification.

Basic elements of the research rationale

Every research rationale should include some mention or discussion of the following: 

• An overview of your conclusions from your literature review
• Gaps in current knowledge
• Inconclusive or controversial findings from previous studies
• The need to build on previous research (e.g. unanswered questions, the need to update concepts in light of new findings and/or new technical advancements). 

Example of a research rationale

Note: This uses a fictional study.

Abc xyz is a newly identified microalgal species isolated from fish tanks. While Abc xyz algal blooms have been seen as a threat to pisciculture, some studies have hinted at their unusually high carotenoid content and unique carotenoid profile. Carotenoid profiling has been carried out only in a handful of microalgal species from this genus, and the search for microalgae rich in bioactive carotenoids has not yielded promising candidates so far. This in-depth examination of the carotenoid profile of Abc xyz will help identify and quantify novel and potentially useful carotenoids from an untapped aquaculture resource .

In conclusion

It is important to describe the rationale of your research in order to put the significance and novelty of your specific research project into perspective. Once you have successfully articulated the reason(s) for your research, you will have convinced readers of the importance of your work!

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Developing a Theoretical Framework and Rationale for a Research Proposal

• First Online: 01 January 2010

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• Gregory M. Herek 4  

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It is useful to recall that our work as scientists will be at its best when it simultaneously tackles real-world problems and enriches our understanding of basic biological, psychological, or social processes. A good theory can help us do both. All empirical research is based on assumptions. Even purely “descriptive” or “exploratory” studies necessarily involve choices about the phenomena and variables to observe and the level of detail at which to observe them. Researchers planning an empirical study confront the challenges of making these assumptions explicit, examining them critically, and designing the investigation to yield data that permit those assumptions to be evaluated and modified appropriately. This is the process of theory construction. Unfortunately, although all research is based on theory, many grant proposals lack a well-developed theoretical rationale. The theoretical framework often remains implicit in the proposal without being formally articulated. Consequently, even though the application may be based on a good idea, it is conceptually weak and receives a poor priority/impact score. This chapter will give you a useful strategy for developing a clearly articulated theoretical framework for your research project and using it to write your entire research plan.

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Acknowledgements

Preparation of this chapter was originally supported in part by a grant to the first author from the National Institute of Mental Health (K02 MH01455). The author gratefully acknowledges the assistance of Dr. William Woods, who gave insightful comments on an earlier draft.

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Herek, G.M. (2010). Developing a Theoretical Framework and Rationale for a Research Proposal. In: Pequegnat, W., Stover, E., Boyce, C. (eds) How to Write a Successful Research Grant Application. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-1454-5_12

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Writing a rationale

How to write a rationale.

What is a rationale?

A rationale is when you are asked to give the reasoning or justification for an action or a choice you make.

There is a focus on the ‘ why ’ in a rationale: why you chose to do something, study or focus on something. It is a set of statements of purpose and significance and often addresses a gap or a need.

A rationale in Australian academic writing is rarely a whole task by itself.  It is often a part of a bigger task. For example, a part of a lesson plan might be to provide a rationale for why you chose to teach particular content or use a certain resource or activity, or you may be asked to provide a rationale as to why you chose a particular theory to apply or a concept to support.

You may be called upon to provide a rationale:

prior to an action or decision; why you plan to do something and how, or

• after you have acted or decided something; reflecting, looking back, why you did something and how it worked or not.

You can use language to signal you are clearly providing a rationale in your writing. You can link your rationale to learning outcomes or aims for a lesson, activity or assessment task.

A model: problem-solution-rationale

A rationale can be provided by offering longer essay-based support for why it is important to do something in a certain way – in that sense, a whole paper can be a rationale.

However, a more specific or focused way of thinking about a rationale is how we can overtly show we are justifying our choices with the language we use.

One way of doing this is to consider the problem or issue requiring attention, the solution and then the rationale or justification for the solution (the ‘why’). This sets the rationale (the reason) within a context.

A diagnostic assessment determined that the students required more attention to addition and subtraction of mixed fractions. This activity intends to address this problem by having the children engage with the task with blocks before it is done with figures. The reason I chose to do this is because students have higher comprehension levels when presented with visual or tangible representations of abstract problems (Benson, 2016). I also did this as I wanted to allow the children to ‘play’ with maths, to see that it can be a fun activity and in doing so, to breakdown some of the ‘anti-mathematics prejudices’ that Gaines (2017, p. 4) talks about.

The important thing here is the language used to signal the rationale , in this case:

The reason I chose to do this is because … and I also did this as …

Another problem / solution / rationale example:

Scaffolding is the support provided by the teacher or a significant other, such as a classmate, which helps students in learning (Gibbons, 2015). Some students were having difficulty with the language at entry while others, particularly those who had completed the pre-tasks, had few problems. Therefore, in order to address this disparity in level and understanding, mixed-ability pairs were created where the more competent student helped the other. On reflection, this was an effective way to run the activity for two reasons : it allowed peer-to-peer teaching which solidified both students’ understanding; and it scaffolded the support in a way that allowed me to roam the room lending advice to pairs as needed.

The language used to signal our rationale in this example:

in order to and for two reasons …

Language to signal rationale

in order to

the reason this was done/chosen …

for the following reason(s) …

for two/three reasons …

Language for further justification - showing importance

This was important / significant because …

This meant that I could…

This enabled me to …

… which enabled / allowed me to…

… which pointed to / highlighted that / showed me that …

The key thing to remember about rationale writing is to stand back from the writing, look at it in a big picture sense and ask yourself, ‘ Have I explained why? ’ If that is clearly articulated, you have provided a rationale.

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• How to Write a Research Proposal | Examples & Templates

How to Write a Research Proposal | Examples & Templates

Published on 30 October 2022 by Shona McCombes and Tegan George. Revised on 13 June 2023.

A research proposal describes what you will investigate, why it’s important, and how you will conduct your research.

The format of a research proposal varies between fields, but most proposals will contain at least these elements:

Introduction

Literature review.

• Research design

Reference list

While the sections may vary, the overall objective is always the same. A research proposal serves as a blueprint and guide for your research plan, helping you get organised and feel confident in the path forward you choose to take.

Table of contents

Research proposal purpose, research proposal examples, research design and methods, contribution to knowledge, research schedule, frequently asked questions.

Academics often have to write research proposals to get funding for their projects. As a student, you might have to write a research proposal as part of a grad school application , or prior to starting your thesis or dissertation .

In addition to helping you figure out what your research can look like, a proposal can also serve to demonstrate why your project is worth pursuing to a funder, educational institution, or supervisor.

Research proposal length

The length of a research proposal can vary quite a bit. A bachelor’s or master’s thesis proposal can be just a few pages, while proposals for PhD dissertations or research funding are usually much longer and more detailed. Your supervisor can help you determine the best length for your work.

One trick to get started is to think of your proposal’s structure as a shorter version of your thesis or dissertation , only without the results , conclusion and discussion sections.

Download our research proposal template

Prevent plagiarism, run a free check.

Writing a research proposal can be quite challenging, but a good starting point could be to look at some examples. We’ve included a few for you below.

• Example research proposal #1: ‘A Conceptual Framework for Scheduling Constraint Management’
• Example research proposal #2: ‘ Medical Students as Mediators of Change in Tobacco Use’

Like your dissertation or thesis, the proposal will usually have a title page that includes:

• The proposed title of your project
• Your supervisor’s name
• Your institution and department

The first part of your proposal is the initial pitch for your project. Make sure it succinctly explains what you want to do and why.

Your introduction should:

• Introduce your topic
• Give necessary background and context
• Outline your  problem statement  and research questions

To guide your introduction , include information about:

• Who could have an interest in the topic (e.g., scientists, policymakers)
• How much is already known about the topic
• What is missing from this current knowledge
• What new insights your research will contribute
• Why you believe this research is worth doing

As you get started, it’s important to demonstrate that you’re familiar with the most important research on your topic. A strong literature review  shows your reader that your project has a solid foundation in existing knowledge or theory. It also shows that you’re not simply repeating what other people have already done or said, but rather using existing research as a jumping-off point for your own.

In this section, share exactly how your project will contribute to ongoing conversations in the field by:

• Comparing and contrasting the main theories, methods, and debates
• Examining the strengths and weaknesses of different approaches
• Explaining how will you build on, challenge, or synthesise prior scholarship

Following the literature review, restate your main  objectives . This brings the focus back to your own project. Next, your research design or methodology section will describe your overall approach, and the practical steps you will take to answer your research questions.

To finish your proposal on a strong note, explore the potential implications of your research for your field. Emphasise again what you aim to contribute and why it matters.

For example, your results might have implications for:

• Improving best practices
• Informing policymaking decisions
• Strengthening a theory or model
• Challenging popular or scientific beliefs
• Creating a basis for future research

Last but not least, your research proposal must include correct citations for every source you have used, compiled in a reference list . To create citations quickly and easily, you can use our free APA citation generator .

Some institutions or funders require a detailed timeline of the project, asking you to forecast what you will do at each stage and how long it may take. While not always required, be sure to check the requirements of your project.

Here’s an example schedule to help you get started. You can also download a template at the button below.

Download our research schedule template

If you are applying for research funding, chances are you will have to include a detailed budget. This shows your estimates of how much each part of your project will cost.

Make sure to check what type of costs the funding body will agree to cover. For each item, include:

• Cost : exactly how much money do you need?
• Justification : why is this cost necessary to complete the research?
• Source : how did you calculate the amount?

To determine your budget, think about:

• Travel costs : do you need to go somewhere to collect your data? How will you get there, and how much time will you need? What will you do there (e.g., interviews, archival research)?
• Materials : do you need access to any tools or technologies?
• Help : do you need to hire any research assistants for the project? What will they do, and how much will you pay them?

Once you’ve decided on your research objectives , you need to explain them in your paper, at the end of your problem statement.

Keep your research objectives clear and concise, and use appropriate verbs to accurately convey the work that you will carry out for each one.

I will compare …

A research aim is a broad statement indicating the general purpose of your research project. It should appear in your introduction at the end of your problem statement , before your research objectives.

Research objectives are more specific than your research aim. They indicate the specific ways you’ll address the overarching aim.

A PhD, which is short for philosophiae doctor (doctor of philosophy in Latin), is the highest university degree that can be obtained. In a PhD, students spend 3–5 years writing a dissertation , which aims to make a significant, original contribution to current knowledge.

A PhD is intended to prepare students for a career as a researcher, whether that be in academia, the public sector, or the private sector.

A master’s is a 1- or 2-year graduate degree that can prepare you for a variety of careers.

All master’s involve graduate-level coursework. Some are research-intensive and intend to prepare students for further study in a PhD; these usually require their students to write a master’s thesis . Others focus on professional training for a specific career.

Critical thinking refers to the ability to evaluate information and to be aware of biases or assumptions, including your own.

Like information literacy , it involves evaluating arguments, identifying and solving problems in an objective and systematic way, and clearly communicating your ideas.

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Examples of research proposals

How to write your research proposal, with examples of good proposals.

Research proposals

Your research proposal is a key part of your application. It tells us about the question you want to answer through your research. It is a chance for you to show your knowledge of the subject area and tell us about the methods you want to use.

We use your research proposal to match you with a supervisor or team of supervisors.

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When you write your proposal you need to:

• Highlight how it is original or significant
• Explain how it will develop or challenge current knowledge of your subject
• Identify the importance of your research
• Show why you are the right person to do this research
• Research Proposal Example 1 (DOC, 49kB)
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• Published: 13 May 2024

Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial

• Donna H. Ryan 1 ,
• Ildiko Lingvay   ORCID: orcid.org/0000-0001-7006-7401 2 ,
• John Deanfield 3 ,
• Steven E. Kahn 4 ,
• Eric Barros   ORCID: orcid.org/0000-0001-6613-4181 5 ,
• Bartolome Burguera 6 ,
• Helen M. Colhoun   ORCID: orcid.org/0000-0002-8345-3288 7 ,
• Cintia Cercato   ORCID: orcid.org/0000-0002-6181-4951 8 ,
• Dror Dicker 9 ,
• Deborah B. Horn 10 ,
• G. Kees Hovingh 5 ,
• Ole Kleist Jeppesen 5 ,
• Alexander Kokkinos 11 ,
• A. Michael Lincoff   ORCID: orcid.org/0000-0001-8175-2121 12 ,
• Sebastian M. Meyhöfer 13 ,
• Tugce Kalayci Oral 5 ,
• Jorge Plutzky   ORCID: orcid.org/0000-0002-7194-9876 14 ,
• André P. van Beek   ORCID: orcid.org/0000-0002-0335-8177 15 ,
• John P. H. Wilding   ORCID: orcid.org/0000-0003-2839-8404 16 &
• Robert F. Kushner 17  

Nature Medicine ( 2024 ) Cite this article

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In the SELECT cardiovascular outcomes trial, semaglutide showed a 20% reduction in major adverse cardiovascular events in 17,604 adults with preexisting cardiovascular disease, overweight or obesity, without diabetes. Here in this prespecified analysis, we examined effects of semaglutide on weight and anthropometric outcomes, safety and tolerability by baseline body mass index (BMI). In patients treated with semaglutide, weight loss continued over 65 weeks and was sustained for up to 4 years. At 208 weeks, semaglutide was associated with mean reduction in weight (−10.2%), waist circumference (−7.7 cm) and waist-to-height ratio (−6.9%) versus placebo (−1.5%, −1.3 cm and −1.0%, respectively; P  < 0.0001 for all comparisons versus placebo). Clinically meaningful weight loss occurred in both sexes and all races, body sizes and regions. Semaglutide was associated with fewer serious adverse events. For each BMI category (<30, 30 to <35, 35 to <40 and ≥40 kg m − 2 ) there were lower rates (events per 100 years of observation) of serious adverse events with semaglutide (43.23, 43.54, 51.07 and 47.06 for semaglutide and 50.48, 49.66, 52.73 and 60.85 for placebo). Semaglutide was associated with increased rates of trial product discontinuation. Discontinuations increased as BMI class decreased. In SELECT, at 208 weeks, semaglutide produced clinically significant weight loss and improvements in anthropometric measurements versus placebo. Weight loss was sustained over 4 years. ClinicalTrials.gov identifier: NCT03574597 .

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Effects of a personalized nutrition program on cardiometabolic health: a randomized controlled trial

Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial

What is the pipeline for future medications for obesity?

The worldwide obesity prevalence, defined by body mass index (BMI) ≥30 kg m − 2 , has nearly tripled since 1975 (ref. 1 ). BMI is a good surveillance measure for population changes over time, given its strong correlation with body fat amount on a population level, but it may not accurately indicate the amount or location of body fat at the individual level 2 . In fact, the World Health Organization defines clinical obesity as ‘abnormal or excessive fat accumulation that may impair health’ 1 . Excess abnormal body fat, especially visceral adiposity and ectopic fat, is a driver of cardiovascular (CV) disease (CVD) 3 , 4 , 5 , and contributes to the global chronic disease burden of diabetes, chronic kidney disease, cancer and other chronic conditions 6 , 7 .

Remediating the adverse health effects of excess abnormal body fat through weight loss is a priority in addressing the global chronic disease burden. Improvements in CV risk factors, glycemia and quality-of-life measures including personal well-being and physical functioning generally begin with modest weight loss of 5%, whereas greater weight loss is associated with more improvement in these measures 8 , 9 , 10 . Producing and sustaining durable and clinically significant weight loss with lifestyle intervention alone has been challenging 11 . However, weight-management medications that modify appetite can make attaining and sustaining clinically meaningful weight loss of ≥10% more likely 12 . Recently, weight-management medications, particularly those comprising glucagon-like peptide-1 receptor agonists, that help people achieve greater and more sustainable weight loss have been developed 13 . Once-weekly subcutaneous semaglutide 2.4 mg, a glucagon-like peptide-1 receptor agonist, is approved for chronic weight management 14 , 15 , 16 and at doses of up to 2.0 mg is approved for type 2 diabetes treatment 17 , 18 , 19 . In patients with type 2 diabetes and high CV risk, semaglutide at doses of 0.5 mg and 1.0 mg has been shown to significantly lower the risk of CV events 20 . The SELECT trial (Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity) studied patients with established CVD and overweight or obesity but without diabetes. In SELECT, semaglutide was associated with a 20% reduction in major adverse CV events (hazard ratio 0.80, 95% confidence interval (CI) 0.72 to 0.90; P  < 0.001) 21 . Data derived from the SELECT trial offer the opportunity to evaluate the weight loss efficacy, in a geographically and racially diverse population, of semaglutide compared with placebo over 208 weeks when both are given in addition to standard-of-care recommendations for secondary CVD prevention (but without a focus on targeting weight loss). Furthermore, the data allow examination of changes in anthropometric measures such as BMI, waist circumference (WC) and waist-to-height ratio (WHtR) as surrogates for body fat amount and location 22 , 23 . The diverse population can also be evaluated for changes in sex- and race-specific ‘cutoff points’ for BMI and WC, which have been identified as anthropometric measures that predict cardiometabolic risk 8 , 22 , 23 .

This prespecified analysis of the SELECT trial investigated weight loss and changes in anthropometric indices in patients with established CVD and overweight or obesity without diabetes, who met inclusion and exclusion criteria, within a range of baseline categories for glycemia, renal function and body anthropometric measures.

Study population

The SELECT study enrolled 17,604 patients (72.3% male) from 41 countries between October 2018 and March 2021, with a mean (s.d.) age of 61.6 (8.9) years and BMI of 33.3 (5.0) kg m − 2 (ref. 21 ). The baseline characteristics of the population have been reported 24 . Supplementary Table 1 outlines SELECT patients according to baseline BMI categories. Of note, in the lower BMI categories (<30 kg m − 2 (overweight) and 30 to <35 kg m − 2 (class I obesity)), the proportion of Asian individuals was higher (14.5% and 7.4%, respectively) compared with the proportion of Asian individuals in the higher BMI categories (BMI 35 to <40 kg m − 2 (class II obesity; 3.8%) and ≥40 kg m − 2 (class III obesity; 2.2%), respectively). As the BMI categories increased, the proportion of women was higher: in the class III BMI category, 45.5% were female, compared with 20.8%, 25.7% and 33.0% in the overweight, class I and class II categories, respectively. Lower BMI categories were associated with a higher proportion of patients with normoglycemia and glycated hemoglobin <5.7%. Although the proportions of patients with high cholesterol and history of smoking were similar across BMI categories, the proportion of patients with high-sensitivity C-reactive protein ≥2.0 mg dl −1 increased as the BMI category increased. A high-sensitivity C-reactive protein >2.0 mg dl −1 was present in 36.4% of patients in the overweight BMI category, with a progressive increase to 43.3%, 57.3% and 72.0% for patients in the class I, II and III obesity categories, respectively.

Weight and anthropometric outcomes

Percentage weight loss.

The average percentage weight-loss trajectories with semaglutide and placebo over 4 years of observation are shown in Fig. 1a (ref. 21 ). For those in the semaglutide group, the weight-loss trajectory continued to week 65 and then was sustained for the study period through week 208 (−10.2% for the semaglutide group, −1.5% for the placebo group; treatment difference −8.7%; 95% CI −9.42 to −7.88; P  < 0.0001). To estimate the treatment effect while on medication, we performed a first on-treatment analysis (observation period until the first time being off treatment for >35 days). At week 208, mean weight loss in the semaglutide group analyzed as first on-treatment was −11.7% compared with −1.5% for the placebo group (Fig. 1b ; treatment difference −10.2%; 95% CI −11.0 to −9.42; P  < 0.0001).

a , b , Observed data from the in-trial period ( a ) and first on-treatment ( b ). The symbols are the observed means, and error bars are ±s.e.m. Numbers shown below each panel represent the number of patients contributing to the means. Analysis of covariance with treatment and baseline values was used to estimate the treatment difference. Exact P values are 1.323762 × 10 −94 and 9.80035 × 10 −100 for a and b , respectively. P values are two-sided and are not adjusted for multiplicity. ETD, estimated treatment difference; sema, semaglutide.

Categorical weight loss and individual body weight change

Among in-trial (intention-to-treat principle) patients at week 104, weight loss of ≥5%, ≥10%, ≥15%, ≥20% and ≥25% was achieved by 67.8%, 44.2%, 22.9%, 11.0% and 4.9%, respectively, of those treated with semaglutide compared with 21.3%, 6.9%, 1.7%, 0.6% and 0.1% of those receiving placebo (Fig. 2a ). Individual weight changes at 104 weeks for the in-trial populations for semaglutide and placebo are depicted in Fig. 2b and Fig. 2c , respectively. These waterfall plots show the variation in weight-loss response that occurs with semaglutide and placebo and show that weight loss is more prominent with semaglutide than placebo.

a , Categorical weight loss from baseline at week 104 for semaglutide and placebo. Data from the in-trial period. Bars depict the proportion (%) of patients receiving semaglutide or placebo who achieved ≥5%, ≥10%, ≥15%, ≥20% and ≥25% weight loss. b , c , Percentage change in body weight for individual patients from baseline to week 104 for semaglutide ( b ) and placebo ( c ). Each patient’s percentage change in body weight is plotted as a single bar.

Change in WC

WC change from baseline to 104 weeks has been reported previously in the primary outcome paper 21 . The trajectory of WC change mirrored that of the change in body weight. At week 208, average reduction in WC was −7.7 cm with semaglutide versus −1.3 cm with placebo, with a treatment difference of −6.4 cm (95% CI −7.18 to −5.61; P  < 0.0001) 21 .

WC cutoff points

We analyzed achievement of sex- and race-specific cutoff points for WC by BMI <35 kg m − 2 or ≥35 kg m − 2 , because for BMI >35 kg m − 2 , WC is more difficult technically and, thus, less accurate as a risk predictor 4 , 25 , 26 . Within the SELECT population with BMI <35 kg m − 2 at baseline, 15.0% and 14.3% of the semaglutide and placebo groups, respectively, were below the sex- and race-specific WC cutoff points. At week 104, 41.2% fell below the sex- and race-specific cutoff points for the semaglutide group, compared with only 18.0% for the placebo group (Fig. 3 ).

WC cutoff points; Asian women <80 cm, non-Asian women <88 cm, Asian men <88 cm, non-Asian men <102 cm.

Waist-to-height ratio

At baseline, mean WHtR was 0.66 for the study population. The lowest tertile of the SELECT population at baseline had a mean WHtR <0.62, which is higher than the cutoff point of 0.5 used to indicate increased cardiometabolic risk 27 , suggesting that the trial population had high WCs. At week 208, in the group randomized to semaglutide, there was a relative reduction of 6.9% in WHtR compared with 1.0% in placebo (treatment difference −5.87% points; 95% CI −6.56 to −5.17; P  < 0.0001).

BMI category change

At week 104, 52.4% of patients treated with semaglutide achieved improvement in BMI category compared with 15.7% of those receiving placebo. Proportions of patients in the BMI categories at baseline and week 104 are shown in Fig. 4 , which depicts in-trial patients receiving semaglutide and placebo. The BMI category change reflects the superior weight loss with semaglutide, which resulted in fewer patients being in the higher BMI categories after 104 weeks. In the semaglutide group, 12.0% of patients achieved a BMI <25 kg m − 2 , which is considered the healthy BMI category, compared with 1.2% for placebo; per study inclusion criteria, no patients were in this category at baseline. The proportion of patients with obesity (BMI ≥30 kg m − 2 ) fell from 71.0% to 43.3% in the semaglutide group versus 71.9% to 67.9% in the placebo group.

In the semaglutide group, 12.0% of patients achieved normal weight status at week 104 (from 0% at baseline), compared with 1.2% (from 0% at baseline) for placebo. BMI classes: healthy (BMI <25 kg m − 2 ), overweight (25 to <30 kg m − 2 ), class I obesity (30 to <35 kg m − 2 ), class II obesity (35 to <40 kg m − 2 ) and class III obesity (BMI ≥40 kg m − 2 ).

Weight and anthropometric outcomes by subgroups

The forest plot illustrated in Fig. 5 displays mean body weight percentage change from baseline to week 104 for semaglutide relative to placebo in prespecified subgroups. Similar relationships are depicted for WC changes in prespecified subgroups shown in Extended Data Fig. 1 . The effect of semaglutide (versus placebo) on mean percentage body weight loss as well as reduction in WC was found to be heterogeneous across several population subgroups. Women had a greater difference in mean weight loss with semaglutide versus placebo (−11.1% (95% CI −11.56 to −10.66) versus −7.5% in men (95% CI −7.78 to −7.23); P  < 0.0001). There was a linear relationship between age category and degree of mean weight loss, with younger age being associated with progressively greater mean weight loss, but the actual mean difference by age group is small. Similarly, BMI category had small, although statistically significant, associations. Those with WHtR less than the median experienced slightly lower mean body weight change than those above the median, with estimated treatment differences −8.04% (95% CI −8.37 to −7.70) and −8.99% (95% CI −9.33 to −8.65), respectively ( P  < 0.0001). Patients from Asia and of Asian race experienced slightly lower mean weight loss (estimated treatment difference with semaglutide for Asian race −7.27% (95% CI −8.09 to −6.46; P  = 0.0147) and for Asia −7.30 (95% CI −7.97 to −6.62; P  = 0.0016)). There was no difference in weight loss with semaglutide associated with ethnicity (estimated treatment difference for Hispanic −8.53% (95% CI −9.28 to −7.76) or non-Hispanic −8.52% (95% CI −8.77 to 8.26); P  = 0.9769), glycemic status (estimated treatment difference for prediabetes −8.53% (95% CI −8.83 to −8.24) or normoglycemia −8.48% (95% CI −8.88 to −8.07; P  = 0.8188) or renal function (estimated treatment difference for estimated glomerular filtration rate (eGFR) <60 or ≥60 ml min −1  1.73 m − 2 being −8.50% (95% CI −9.23 to −7.76) and −8.52% (95% CI −8.77 to −8.26), respectively ( P  = 0.9519)).

Data from the in-trial period. N  = 17,604. P values represent test of no interaction effect. P values are two-sided and are not adjusted for multiplicity. The dots show estimated treatment differences, and the error bars show 95% CIs. Details of the statistical models are available in Methods . ETD, estimated treatment difference; HbA1c, glycated hemoglobin; MI, myocardial infarction; PAD, peripheral artery disease; sema, semaglutide.

Safety and tolerability according to baseline BMI category

We reported in the primary outcome of the SELECT trial that adverse events (AEs) leading to permanent discontinuation of the trial product occurred in 1,461 patients (16.6%) in the semaglutide group and 718 patients (8.2%) in the placebo group ( P  < 0.001) 21 . For this analysis, we evaluated the cumulative incidence of AEs leading to trial product discontinuation by treatment assignment and by BMI category (Fig. 6 ). For this analysis, with death modeled as a competing risk, we tracked the proportion of in-trial patients for whom drug was withdrawn or interrupted for the first time (Fig. 6 , left) or cumulative discontinuations (Fig. 6 , right). Both panels of Fig. 6 depict a graded increase in the proportion discontinuing semaglutide, but not placebo. For lower BMI classes, discontinuation rates are higher in the semaglutide group but not the placebo group.

Data are in-trial from the full analysis set. sema, semaglutide.

We reported in the primary SELECT analysis that serious adverse events (SAEs) were reported by 2,941 patients (33.4%) in the semaglutide arm and by 3,204 patients (36.4%) in the placebo arm ( P  < 0.001) 21 . For this study, we analyzed SAE rates by person-years of treatment exposure for BMI classes (<30 kg m − 2 , 30 to <35 kg m − 2 , 35 to <40 kg m − 2 , and ≥40 kg m − 2 ) and provide these data in Supplementary Table 2 . We also provide an analysis of the most common categories of SAEs. Semaglutide was associated with lower SAEs, primarily driven by CV event and infections. Within each obesity class (<30 kg m − 2 , 30 to <35 kg m − 2 , 35 to <40 kg m − 2 , and ≥40 kg m − 2 ), there were fewer SAEs in the group receiving semaglutide compared with placebo. Rates (events per 100 years of observation) of SAEs were 43.23, 43.54, 51.07 and 47.06 for semaglutide and 50.48, 49.66, 52.73 and 60.85 for placebo, with no evidence of heterogeneity. There was no detectable difference in hepatobiliary or gastrointestinal SAEs comparing semaglutide with placebo in any of the four BMI classes we evaluated.

The analyses of weight effects of the SELECT study presented here reveal that patients assigned to once-weekly subcutaneous semaglutide 2.4 mg lost significantly more weight than those receiving placebo. The weight-loss trajectory with semaglutide occurred over 65 weeks and was sustained up to 4 years. Likewise, there were similar improvements in the semaglutide group for anthropometrics (WC and WHtR). The weight loss was associated with a greater proportion of patients receiving semaglutide achieving improvement in BMI category, healthy BMI (<25 kg m − 2 ) and falling below the WC cutoff point above which increased cardiometabolic risk for the sex and race is greater 22 , 23 . Furthermore, both sexes, all races, all body sizes and those from all geographic regions were able to achieve clinically meaningful weight loss. There was no evidence of increased SAEs based on BMI categories, although lower BMI category was associated with increased rates of trial product discontinuation, probably reflecting exposure to a higher level of drug in lower BMI categories. These data, representing the longest clinical trial of the effects of semaglutide versus placebo on weight, establish the safety and durability of semaglutide effects on weight loss and maintenance in a geographically and racially diverse population of adult men and women with overweight and obesity but not diabetes. The implications of weight loss of this degree in such a diverse population suggests that it may be possible to impact the public health burden of the multiple morbidities associated with obesity. Although our trial focused on CV events, many chronic diseases would benefit from effective weight management 28 .

There were variations in the weight-loss response. Individual changes in body weight with semaglutide and placebo were striking; still, 67.8% achieved 5% or more weight loss and 44.2% achieved 10% weight loss with semaglutide at 2 years, compared with 21.3% and 6.9%, respectively, for those receiving placebo. Our first on-treatment analysis demonstrated that those on-drug lost more weight than those in-trial, confirming the effect of drug exposure. With semaglutide, lower BMI was associated with less percentage weight loss, and women lost more weight on average than men (−11.1% versus −7.5% treatment difference from placebo); however, in all cases, clinically meaningful mean weight loss was achieved. Although Asian patients lost less weight on average than patients of other races (−7.3% more than placebo), Asian patients were more likely to be in the lowest BMI category (<30 kg m − 2 ), which is known to be associated with less weight loss, as discussed below. Clinically meaningful weight loss was evident in the semaglutide group within a broad range of baseline categories for glycemia and body anthropometrics. Interestingly, at 2 years, a significant proportion of the semaglutide-treated group fell below the sex- and race-specific WC cutoff points, especially in those with BMI <35 kg m − 2 , and a notable proportion (12.0%) fell below the BMI cutoff point of 25 kg m − 2 , which is deemed a healthy BMI in those without unintentional weight loss. As more robust weight loss is possible with newer medications, achieving and maintaining these cutoff point targets may become important benchmarks for tracking responses.

The overall safety profile did not reveal any new signals from prior studies, and there were no BMI category-related associations with AE reporting. The analysis did reveal that tolerability may differ among specific BMI classes, since more discontinuations occurred with semaglutide among lower BMI classes. Potential contributors may include a possibility of higher drug exposure in lower BMI classes, although other explanations, including differences in motivation and cultural mores regarding body size, cannot be excluded.

Is the weight loss in SELECT less than expected based on prior studies with the drug? In STEP 1, a large phase 3 study of once-weekly subcutaneous semaglutide 2.4 mg in individuals without diabetes but with BMI >30 kg m − 2 or 27 kg m − 2 with at least one obesity-related comorbidity, the mean weight loss was −14.9% at week 68, compared with −2.4% with placebo 14 . Several reasons may explain the observation that the mean treatment difference was −12.5% in STEP 1 and −8.7% in SELECT. First, SELECT was designed as a CV outcomes trial and not a weight-loss trial, and weight loss was only a supportive secondary endpoint in the trial design. Patients in STEP 1 were desirous of weight loss as a reason for study participation and received structured lifestyle intervention (which included a −500 kcal per day diet with 150 min per week of physical activity). In the SELECT trial, patients did not enroll for the specific purpose of weight loss and received standard of care covering management of CV risk factors, including medical treatment and healthy lifestyle counseling, but without a specific focus on weight loss. Second, the respective study populations were quite different, with STEP 1 including a younger, healthier population with more women (73.1% of the semaglutide arm in STEP 1 versus 27.7% in SELECT) and higher mean BMI (37.8 kg m − 2 versus 33.3 kg m − 2 , respectively) 14 , 21 . Third, major differences existed between the respective trial protocols. Patients in the semaglutide treatment arm of STEP 1 were more likely to be exposed to the medication at the full dose of 2.4 mg than those in SELECT. In SELECT, investigators were allowed to slow, decrease or pause treatment. By 104 weeks, approximately 77% of SELECT patients on dose were receiving the target semaglutide 2.4 mg weekly dose, which is lower than the corresponding proportion of patients in STEP 1 (89.6% were receiving the target dose at week 68) 14 , 21 . Indeed, in our first on-treatment analysis at week 208, weight loss was greater (−11.7% for semaglutide) compared with the in-trial analysis (−10.2% for semaglutide). Taken together, all these issues make less weight loss an expected finding in SELECT, compared with STEP 1.

The SELECT study has some limitations. First, SELECT was not a primary prevention trial, and the data should not be extrapolated to all individuals with overweight and obesity to prevent major adverse CV events. Although the data set is rich in numbers and diversity, it does not have the numbers of individuals in racial subgroups that may have revealed potential differential effects. SELECT also did not include individuals who have excess abnormal body fat but a BMI <27 kg m − 2 . Not all individuals with increased CV risk have BMI ≥27 kg m − 2 . Thus, the study did not include Asian patients who qualify for treatment with obesity medications at lower BMI and WC cutoff points according to guidelines in their countries 29 . We observed that Asian patients were less likely to be in the higher BMI categories of SELECT and that the population of those with BMI <30 kg m − 2 had a higher percentage of Asian race. Asian individuals would probably benefit from weight loss and medication approaches undertaken at lower BMI levels in the secondary prevention of CVD. Future studies should evaluate CV risk reduction in Asian individuals with high CV risk and BMI <27 kg m − 2 . Another limitation is the lack of information on body composition, beyond the anthropometric measures we used. It would be meaningful to have quantitation of fat mass, lean mass and muscle mass, especially given the wide range of body size in the SELECT population.

An interesting observation from this SELECT weight loss data is that when BMI is ≤30 kg m − 2 , weight loss on a percentage basis is less than that observed across higher classes of BMI severity. Furthermore, as BMI exceeds 30 kg m − 2 , weight loss amounts are more similar for class I, II and III obesity. This was also observed in Look AHEAD, a lifestyle intervention study for weight loss 30 . The proportion (percentage) of weight loss seems to be less, on average, in the BMI <30 kg m − 2 category relative to higher BMI categories, despite their receiving of the same treatment and even potentially higher exposure to the drug for weight loss 30 . Weight loss cannot continue indefinitely. There is a plateau of weight that occurs after weight loss with all treatments for weight management. This plateau has been termed the ‘set point’ or ‘settling point’, a body weight that is in harmony with the genetic and environmental determinants of body weight and adiposity 31 . Perhaps persons with BMI <30 kg m − 2 are closer to their settling point and have less weight to lose to reach it. Furthermore, the cardiometabolic benefits of weight loss are driven by reduction in the abnormal ectopic and visceral depots of fat, not by reduction of subcutaneous fat stores in the hips and thighs. The phenotype of cardiometabolic disease but lower BMI (<30 kg m − 2 ) may be one where reduction of excess abnormal and dysfunctional body fat does not require as much body mass reduction to achieve health improvement. We suspect this may be the case and suggest further studies to explore this aspect of weight-loss physiology.

In conclusion, this analysis of the SELECT study supports the broad use of once-weekly subcutaneous semaglutide 2.4 mg as an aid to CV event reduction in individuals with overweight or obesity without diabetes but with preexisting CVD. Semaglutide 2.4 mg safely and effectively produced clinically significant weight loss in all subgroups based on age, sex, race, glycemia, renal function and anthropometric categories. Furthermore, the weight loss was sustained over 4 years during the trial.

Trial design and participants

The current work complies with all relevant ethical regulations and reports a prespecified analysis of the randomized, double-blind, placebo-controlled SELECT trial ( NCT03574597 ), details of which have been reported in papers describing study design and rationale 32 , baseline characteristics 24 and the primary outcome 21 . SELECT evaluated once-weekly subcutaneous semaglutide 2.4 mg versus placebo to reduce the risk of major adverse cardiac events (a composite endpoint comprising CV death, nonfatal myocardial infarction or nonfatal stroke) in individuals with established CVD and overweight or obesity, without diabetes. The protocol for SELECT was approved by national and institutional regulatory and ethical authorities in each participating country. All patients provided written informed consent before beginning any trial-specific activity. Eligible patients were aged ≥45 years, with a BMI of ≥27 kg m − 2 and established CVD defined as at least one of the following: prior myocardial infarction, prior ischemic or hemorrhagic stroke, or symptomatic peripheral artery disease. Additional inclusion and exclusion criteria can be found elsewhere 32 .

Human participants research

The trial protocol was designed by the trial sponsor, Novo Nordisk, and the academic Steering Committee. A global expert panel of physician leaders in participating countries advised on regional operational issues. National and institutional regulatory and ethical authorities approved the protocol, and all patients provided written informed consent.

Study intervention and patient management

Patients were randomly assigned in a double-blind manner and 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo. The starting dose was 0.24 mg once weekly, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) until the target dose of 2.4 mg was reached after 16 weeks. Patients who were unable to tolerate dose escalation due to AEs could be managed by extension of dose-escalation intervals, treatment pauses or maintenance at doses below the 2.4 mg per week target dose. Investigators were allowed to reduce the dose of study product if tolerability issues arose. Investigators were provided with guidelines for, and encouraged to follow, evidence-based recommendations for medical treatment and lifestyle counseling to optimize management of underlying CVD as part of the standard of care. The lifestyle counseling was not targeted at weight loss. Additional intervention descriptions are available 32 .

Sex, race, body weight, height and WC measurements

Sex and race were self-reported. Body weight was measured without shoes and only wearing light clothing; it was measured on a digital scale and recorded in kilograms or pounds (one decimal with a precision of 0.1 kg or lb), with preference for using the same scale throughout the trial. The scale was calibrated yearly as a minimum unless the manufacturer certified that calibration of the weight scales was valid for the lifetime of the scale. Height was measured without shoes in centimeters or inches (one decimal with a precision of 0.1 cm or inches). At screening, BMI was calculated by the electronic case report form. WC was defined as the abdominal circumference located midway between the lower rib margin and the iliac crest. Measures were obtained in a standing position with a nonstretchable measuring tape and to the nearest centimeter or inch. The patient was asked to breathe normally. The tape touched the skin but did not compress soft tissue, and twists in the tape were avoided.

The following endpoints relevant to this paper were assessed at randomization (week 0) to years 2, 3 and 4: change in body weight (%); proportion achieving weight loss ≥5%, ≥10%, ≥15% and ≥20%; change in WC (cm); and percentage change in WHtR (cm cm −1 ). Improvement in BMI category (defined as being in a lower BMI class) was assessed at week 104 compared with baseline according to BMI classes: healthy (BMI <25 kg m − 2 ), overweight (25 to <30 kg m − 2 ), class I obesity (30 to <35 kg m − 2 ), class II obesity (35 to <40 kg m − 2 ) and class III obesity (≥40 kg m − 2 ). The proportions of individuals with BMI <35 or ≥35 kg m − 2 who achieved sex- and race-specific cutoff points for WC (indicating increased metabolic risk) were evaluated at week 104. The WC cutoff points were as follows: Asian women <80 cm, non-Asian women <88 cm, Asian men <88 cm and non-Asian men <102 cm.

Overall, 97.1% of the semaglutide group and 96.8% of the placebo group completed the trial. During the study, 30.6% of those assigned to semaglutide did not complete drug treatment, compared with 27.0% for placebo.

Statistical analysis

The statistical analyses for the in-trial period were based on the intention-to-treat principle and included all randomized patients irrespective of adherence to semaglutide or placebo or changes to background medications. Continuous endpoints were analyzed using an analysis of covariance model with treatment as a fixed factor and baseline value of the endpoint as a covariate. Missing data at the landmark visit, for example, week 104, were imputed using a multiple imputation model and done separately for each treatment arm and included baseline value as a covariate and fit to patients having an observed data point (irrespective of adherence to randomized treatment) at week 104. The fit model is used to impute values for all patients with missing data at week 104 to create 500 complete data sets. Rubin’s rules were used to combine the results. Estimated means are provided with s.e.m., and estimated treatment differences are provided with 95% CI. Binary endpoints were analyzed using logistic regression with treatment and baseline value as a covariate, where missing data were imputed by first using multiple imputation as described above and then categorizing the imputed data according to the endpoint, for example, body weight percentage change at week 104 of <0%. Subgroup analyses for continuous and binary endpoints also included the subgroup and interaction between treatment and subgroup as fixed factors. Because some patients in both arms continued to be followed but were off treatment, we also analyzed weight loss by first on-treatment group (observation period until first time being off treatment for >35 days) to assess a more realistic picture of weight loss in those adhering to treatment. CIs were not adjusted for multiplicity and should therefore not be used to infer definitive treatment effects. All statistical analyses were performed with SAS software, version 9.4 TS1M5 (SAS Institute).

Reporting summary

Further information on research design is available in the Nature Portfolio Reporting Summary linked to this article.

Data availability

Data will be shared with bona fide researchers who submit a research proposal approved by the independent review board. Individual patient data will be shared in data sets in a deidentified and anonymized format. Information about data access request proposals can be found at https://www.novonordisk-trials.com/ .

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Acknowledgements

Editorial support was provided by Richard Ogilvy-Stewart of Apollo, OPEN Health Communications, and funded by Novo Nordisk A/S, in accordance with Good Publication Practice guidelines ( www.ismpp.org/gpp-2022 ).

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Department of Internal Medicine/Endocrinology and Peter O’ Donnell Jr. School of Public Health, University of Texas Southwestern Medical Center, Dallas, TX, USA

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Steven E. Kahn

Novo Nordisk A/S, Søborg, Denmark

Eric Barros, G. Kees Hovingh, Ole Kleist Jeppesen & Tugce Kalayci Oral

Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH, USA

Bartolome Burguera

Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK

Helen M. Colhoun

Obesity Unit, Department of Endocrinology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil

Cintia Cercato

Internal Medicine Department D, Hasharon Hospital-Rabin Medical Center, Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

Dror Dicker

Center for Obesity Medicine and Metabolic Performance, Department of Surgery, University of Texas McGovern Medical School, Houston, TX, USA

Deborah B. Horn

First Department of Propaedeutic Internal Medicine, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece

Alexander Kokkinos

Department of Cardiovascular Medicine, Cleveland Clinic, and Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, USA

A. Michael Lincoff

Institute of Endocrinology & Diabetes, University of Lübeck, Lübeck, Germany

Sebastian M. Meyhöfer

Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

Jorge Plutzky

University of Groningen, University Medical Center Groningen, Department of Endocrinology, Groningen, the Netherlands

André P. van Beek

Department of Cardiovascular and Metabolic Medicine, University of Liverpool, Liverpool, UK

John P. H. Wilding

Northwestern University Feinberg School of Medicine, Chicago, IL, USA

Robert F. Kushner

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Contributions

D.H.R., I.L. and S.E.K. contributed to the study design. D.B.H., I.L., D.D., A.K., S.M.M., A.P.v.B., C.C. and J.P.H.W. were study investigators. D.B.H., I.L., D.D., A.K., S.M.M., A.P.v.B., C.C. and J.P.H.W. enrolled patients. D.H.R. was responsible for data analysis and manuscript preparation. All authors contributed to data interpretation, review, revisions and final approval of the manuscript.

Corresponding author

Correspondence to Donna H. Ryan .

Ethics declarations

Competing interests.

D.H.R. declares having received consulting honoraria from Altimmune, Amgen, Biohaven, Boehringer Ingelheim, Calibrate, Carmot Therapeutics, CinRx, Eli Lilly, Epitomee, Gila Therapeutics, IFA Celtics, Novo Nordisk, Pfizer, Rhythm, Scientific Intake, Wondr Health and Zealand Pharma; she declares she received stock options from Calibrate, Epitomee, Scientific Intake and Xeno Bioscience. I.L. declares having received research funding (paid to institution) from Novo Nordisk, Sanofi, Mylan and Boehringer Ingelheim. I.L. received advisory/consulting fees and/or other support from Altimmune, AstraZeneca, Bayer, Biomea, Boehringer Ingelheim, Carmot Therapeutics, Cytoki Pharma, Eli Lilly, Intercept, Janssen/Johnson & Johnson, Mannkind, Mediflix, Merck, Metsera, Novo Nordisk, Pharmaventures, Pfizer, Regeneron, Sanofi, Shionogi, Structure Therapeutics, Target RWE, Terns Pharmaceuticals, The Comm Group, Valeritas, WebMD and Zealand Pharma. J.D. declares having received consulting honoraria from Amgen, Boehringer Ingelheim, Merck, Pfizer, Aegerion, Novartis, Sanofi, Takeda, Novo Nordisk and Bayer, and research grants from British Heart Foundation, MRC (UK), NIHR, PHE, MSD, Pfizer, Aegerion, Colgate and Roche. S.E.K. declares having received consulting honoraria from ANI Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Merck, Novo Nordisk and Oramed, and stock options from AltPep. B.B. declares having received honoraria related to participation on this trial and has no financial conflicts related to this publication. H.M.C. declares being a stockholder and serving on an advisory panel for Bayer; receiving research grants from Chief Scientist Office, Diabetes UK, European Commission, IQVIA, Juvenile Diabetes Research Foundation and Medical Research Council; serving on an advisory board and speaker’s bureau for Novo Nordisk; and holding stock in Roche Pharmaceuticals. C.C. declares having received consulting honoraria from Novo Nordisk, Eli Lilly, Merck, Brace Pharma and Eurofarma. D.D. declares having received consulting honoraria from Novo Nordisk, Eli Lilly, Boehringer Ingelheim and AstraZeneca, and received research grants through his affiliation from Novo Nordisk, Eli Lilly, Boehringer Ingelheim and Rhythm. D.B.H. declares having received research grants through her academic affiliation from Novo Nordisk and Eli Lilly, and advisory/consulting honoraria from Novo Nordisk, Eli Lilly and Gelesis. A.K. declares having received research grants through his affiliation from Novo Nordisk and Pharmaserve Lilly, and consulting honoraria from Pharmaserve Lilly, Sanofi-Aventis, Novo Nordisk, MSD, AstraZeneca, ELPEN Pharma, Boehringer Ingelheim, Galenica Pharma, Epsilon Health and WinMedica. A.M.L. declares having received honoraria from Novo Nordisk, Eli Lilly, Akebia Therapeutics, Ardelyx, Becton Dickinson, Endologix, FibroGen, GSK, Medtronic, Neovasc, Provention Bio, ReCor, BrainStorm Cell Therapeutics, Alnylam and Intarcia for consulting activities, and research funding to his institution from AbbVie, Esperion, AstraZeneca, CSL Behring, Novartis and Eli Lilly. S.M.M. declares having received consulting honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Daichii-Sankyo, esanum, Gilead, Ipsen, Eli Lilly, Novartis, Novo Nordisk, Sandoz and Sanofi; he declares he received research grants from AstraZeneca, Eli Lilly and Novo Nordisk. J.P. declares having received consulting honoraria from Altimmune, Amgen, Esperion, Merck, MJH Life Sciences, Novartis and Novo Nordisk; he has received a grant, paid to his institution, from Boehringer Ingelheim and holds the position of Director, Preventive Cardiology, at Brigham and Women’s Hospital. A.P.v.B. is contracted via the University of Groningen (no personal payment) to undertake consultancy for Novo Nordisk, Eli Lilly and Boehringer Ingelheim. J.P.H.W. is contracted via the University of Liverpool (no personal payment) to undertake consultancy for Altimmune, AstraZeneca, Boehringer Ingelheim, Cytoki, Eli Lilly, Napp, Novo Nordisk, Menarini, Pfizer, Rhythm Pharmaceuticals, Sanofi, Saniona, Tern Pharmaceuticals, Shionogi and Ysopia. J.P.H.W. also declares personal honoraria/lecture fees from AstraZeneca, Boehringer Ingelheim, Medscape, Napp, Menarini, Novo Nordisk and Rhythm. R.F.K. declares having received consulting honoraria from Novo Nordisk, Weight Watchers, Eli Lilly, Boehringer Ingelheim, Pfizer, Structure and Altimmune. E.B., G.K.H., O.K.J. and T.K.O. are employees of Novo Nordisk A/S.

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Nature Medicine thanks Christiana Kartsonaki, Peter Rossing, Naveed Sattar and Vikas Sridhar for their contribution to the peer review of this work. Primary Handling Editor: Sonia Muliyil, in collaboration with the Nature Medicine team.

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Extended data

Extended data fig. 1 effect of semaglutide treatment or placebo on waist circumference from baseline to week 104 by subgroups..

Data from the in-trial period. N  = 17,604. P values represent test of no interaction effect. P values are two-sided and not adjusted for multiplicity. The dots show estimated treatment differences and the error bars show 95% confidence intervals. Details of the statistical models are available in Methods . BMI, body mass index; CI, confidence interval; CV, cardiovascular; CVD, cardiovascular disease; eGFR, estimated glomerular filtration rate; ETD, estimated treatment difference; HbA1c, glycated hemoglobin; MI, myocardial infarction; PAD, peripheral artery disease; sema, semaglutide.

Supplementary information

Reporting summary, supplementary tables 1 and 2.

Supplementary Table 1. Baseline characteristics by BMI class. Data are represented as number and percentage of patients. Renal function categories were based on the eGFR as per Chronic Kidney Disease Epidemiology Collaboration. Albuminuria categories were based on UACR. Smoking was defined as smoking at least one cigarette or equivalent daily. The category ‘Other’ for CV inclusion criteria includes patients where it is unknown if the patient fulfilled only one or several criteria and patients who were randomized in error and did not fulfill any criteria. Supplementary Table 2. SAEs according to baseline BMI category. P value: two-sided P value from Fisher’s exact test for test of no difference.

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Ryan, D.H., Lingvay, I., Deanfield, J. et al. Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial. Nat Med (2024). https://doi.org/10.1038/s41591-024-02996-7

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Accepted : 12 April 2024

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DOI : https://doi.org/10.1038/s41591-024-02996-7

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Innovating Urban Mosquito Control: Introducing Human-Controlled Breeding Sites as a Component of Integrated Mosquito Management (IMM)

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This study introduces a novel method for mosquito control tailored specifically for urban and suburban areas, addressing their unique challenges. The concept of Human-Controlled Breeding Sites (HCBS) is presented as an innovative approach to reducing mosquito populations by providing controlled oviposition sites within households. The paper is structured into three main components. The first details the meticulous development of the HCBS method, the second explores the intricate development of the HCBS device, crucial for effective implementation of the HCBS approach. Finally, the experiment validating the HCBS methodology is described, offering insights into its practical application and efficacy in mosquito population control. Our proposal emphasizes the importance of considering mosquito needs, behavior and preferences in designing effective mosquito control strategies. Gravid mosquitoes must find a suitable place for oviposition, and HCBS provides an easy-access controlled environment for them to do so within households. Contrary to the commonly current recommendation to destroy all possible locations where mosquitoes can lay their eggs, the HCBS methodology provides an opportunity for gravid mosquitoes to oviposit their eggs without being deterred by chemical odors or dead larvae or pupae. It involves waiting for a timespan before effectively collecting and destroying the individuals in one concerted effort with zero impact on the environment and at minimal cost. Successful deposition of eggs by gravid mosquitoes into HCBS devices, followed by their destruction within the designated timeframe, validates the system's efficacy in disrupting the mosquito life cycle. Moreover, our findings demonstrate the significant influence of color selection on HCBS effectiveness, with green HCBS devices attracting the highest number of gravid female mosquitoes for oviposition. These integrated components offer a comprehensive understanding of the HCBS approach, effectively bridging the gap between methodological development, device design, and practical application. The findings underscore HCBS as a valuable addition to mosquito control strategies, with potential applications in diverse environments. Further research is essential to delve into and model the long-term effectiveness of HCBS, aiming to optimize its design for maximum efficacy and scalability. This includes studying its performance over extended periods and refining the design parameters to enhance its functionality and widespread applicability including the use of disaster risk management systems.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

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All data produced in the present work are contained in the manuscript

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