a case study nutrition

Case report

Nutrition Journal  welcomes well-described reports of cases that include the following:

• Unreported or unusual side effects or adverse interactions involving medications
• Unexpected or unusual presentations of a disease
• New associations or variations in disease processes
• Presentations, diagnoses and/or management of new and emerging diseases
• An unexpected association between diseases or symptoms
• An unexpected event in the course of observing or treating a patient
• Findings that shed new light on the possible pathogenesis of a disease or an adverse effect

Case reports submitted to  Nutrition Journal  should make a contribution to medical knowledge and must have educational value or highlight the need for a change in clinical practice or diagnostic/prognostic approaches. The journal will not consider case reports describing preventive or therapeutic interventions, as these generally require stronger evidence.

Authors are encouraged to describe how the case report is rare or unusual as well as its educational and/or scientific merits in the covering letter that accompanies the submission of the manuscript.

For case reports,  Nutrition Journal  requires authors to follow the CARE guidelines . The  CARE checklist should be provided as an additional files. Submissions received without these elements will be returned to the authors as incomplete.

Nutrition Journal recommends the use of person-first language to speak appropriately about individuals with a disability. For example, when referring to a person with a stroke or diabetes, refer to the person first using a phrase such as 'a person with a stroke' or 'a person affected by diabetes’. This also pertains to descriptions of body weight and eating disturbances, for example, refer to ‘people with obesity’ or ‘people affected by overweight and obesity’ or ‘people affected by disordered eating’.

Preparing your manuscript

The information below details the section headings that you should include in your manuscript and what information should be within each section.

Please note that your manuscript must include a 'Declarations' section including all of the subheadings (please see below for more information).

Title page 

The title page should:

• "A versus B in the treatment of C: a randomized controlled trial", "X is a risk factor for Y: a case control study", "What is the impact of factor X on subject Y: A systematic review, A case report etc."
• or, for non-clinical or non-research studies: a description of what the article reports
• if a collaboration group should be listed as an author, please list the Group name as an author. If you would like the names of the individual members of the Group to be searchable through their individual PubMed records, please include this information in the “Acknowledgements” section in accordance with the instructions below
• Large Language Models (LLMs), such as ChatGPT , do not currently satisfy our authorship criteria . Notably an attribution of authorship carries with it accountability for the work, which cannot be effectively applied to LLMs. Use of an LLM should be properly documented in the Methods section (and if a Methods section is not available, in a suitable alternative part) of the manuscript
•  indicate the corresponding author

The Abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. The abstract must include the following separate sections:

• Background: why the case should be reported and its novelty
• Case presentation: a brief description of the patient’s clinical and demographic details, the diagnosis, any interventions and the outcomes
• Conclusions: a brief summary of the clinical impact or potential implications of the case report

Keywords 

Three to ten keywords representing the main content of the article.

The Background section should explain the background to the case report or study, its aims, a summary of the existing literature.

Case presentation

This section should include a description of the patient’s relevant demographic details, medical history, symptoms and signs, treatment or intervention, outcomes and any other significant details.

Discussion and Conclusions

This should discuss the relevant existing literature and should state clearly the main conclusions, including an explanation of their relevance or importance to the field.

List of abbreviations

If abbreviations are used in the text they should be defined in the text at first use, and a list of abbreviations should be provided.

Declarations

All manuscripts must contain the following sections under the heading 'Declarations':

Ethics approval and consent to participate

Consent for publication, availability of data and materials, competing interests, authors' contributions, acknowledgements.

• Authors' information (optional)

Please see below for details on the information to be included in these sections.

If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section. 

Manuscripts reporting studies involving human participants, human data or human tissue must:

• include a statement on ethics approval and consent (even where the need for approval was waived)
• include the name of the ethics committee that approved the study and the committee’s reference number if appropriate

Studies involving animals must include a statement on ethics approval and for experimental studies involving client-owned animals, authors must also include a statement on informed consent from the client or owner.

See our editorial policies for more information.

If your manuscript does not report on or involve the use of any animal or human data or tissue, please state “Not applicable” in this section.

If your manuscript contains any individual person’s data in any form (including any individual details, images or videos), consent for publication must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent for publication.

You can use your institutional consent form or our consent form if you prefer. You should not send the form to us on submission, but we may request to see a copy at any stage (including after publication).

See our editorial policies for more information on consent for publication.

If your manuscript does not contain data from any individual person, please state “Not applicable” in this section.

All manuscripts must include an ‘Availability of data and materials’ statement. Data availability statements should include information on where data supporting the results reported in the article can be found including, where applicable, hyperlinks to publicly archived datasets analysed or generated during the study. By data we mean the minimal dataset that would be necessary to interpret, replicate and build upon the findings reported in the article. We recognise it is not always possible to share research data publicly, for instance when individual privacy could be compromised, and in such instances data availability should still be stated in the manuscript along with any conditions for access.

Authors are also encouraged to preserve search strings on searchRxiv https://searchrxiv.org/ , an archive to support researchers to report, store and share their searches consistently and to enable them to review and re-use existing searches. searchRxiv enables researchers to obtain a digital object identifier (DOI) for their search, allowing it to be cited. 

Data availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):

• The datasets generated and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
• The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
• All data generated or analysed during this study are included in this published article [and its supplementary information files].
• The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.
• Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
• The data that support the findings of this study are available from [third party name] but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of [third party name].
• Not applicable. If your manuscript does not contain any data, please state 'Not applicable' in this section.

More examples of template data availability statements, which include examples of openly available and restricted access datasets, are available here .

BioMed Central strongly encourages the citation of any publicly available data on which the conclusions of the paper rely in the manuscript. Data citations should include a persistent identifier (such as a DOI) and should ideally be included in the reference list. Citations of datasets, when they appear in the reference list, should include the minimum information recommended by DataCite and follow journal style. Dataset identifiers including DOIs should be expressed as full URLs. For example:

Hao Z, AghaKouchak A, Nakhjiri N, Farahmand A. Global integrated drought monitoring and prediction system (GIDMaPS) data sets. figshare. 2014. http://dx.doi.org/10.6084/m9.figshare.853801

With the corresponding text in the Availability of data and materials statement:

The datasets generated during and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]. [Reference number]  

If you wish to co-submit a data note describing your data to be published in BMC Research Notes , you can do so by visiting our submission portal . Data notes support open data and help authors to comply with funder policies on data sharing. Co-published data notes will be linked to the research article the data support ( example ).

All financial and non-financial competing interests must be declared in this section.

See our editorial policies for a full explanation of competing interests. If you are unsure whether you or any of your co-authors have a competing interest please contact the editorial office.

Please use the authors initials to refer to each authors' competing interests in this section.

If you do not have any competing interests, please state "The authors declare that they have no competing interests" in this section.

All sources of funding for the research reported should be declared. If the funder has a specific role in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript, this should be declared.

The individual contributions of authors to the manuscript should be specified in this section. Guidance and criteria for authorship can be found in our editorial policies .

Please use initials to refer to each author's contribution in this section, for example: "FC analyzed and interpreted the patient data regarding the hematological disease and the transplant. RH performed the histological examination of the kidney, and was a major contributor in writing the manuscript. All authors read and approved the final manuscript."

Please acknowledge anyone who contributed towards the article who does not meet the criteria for authorship including anyone who provided professional writing services or materials.

Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements section.

See our editorial policies for a full explanation of acknowledgements and authorship criteria.

If you do not have anyone to acknowledge, please write "Not applicable" in this section.

Group authorship (for manuscripts involving a collaboration group): if you would like the names of the individual members of a collaboration Group to be searchable through their individual PubMed records, please ensure that the title of the collaboration Group is included on the title page and in the submission system and also include collaborating author names as the last paragraph of the “Acknowledgements” section. Please add authors in the format First Name, Middle initial(s) (optional), Last Name. You can add institution or country information for each author if you wish, but this should be consistent across all authors.

Please note that individual names may not be present in the PubMed record at the time a published article is initially included in PubMed as it takes PubMed additional time to code this information.

Authors' information

This section is optional.

You may choose to use this section to include any relevant information about the author(s) that may aid the reader's interpretation of the article, and understand the standpoint of the author(s). This may include details about the authors' qualifications, current positions they hold at institutions or societies, or any other relevant background information. Please refer to authors using their initials. Note this section should not be used to describe any competing interests.

Footnotes can be used to give additional information, which may include the citation of a reference included in the reference list. They should not consist solely of a reference citation, and they should never include the bibliographic details of a reference. They should also not contain any figures or tables.

Footnotes to the text are numbered consecutively; those to tables should be indicated by superscript lower-case letters (or asterisks for significance values and other statistical data). Footnotes to the title or the authors of the article are not given reference symbols.

Always use footnotes instead of endnotes.

Examples of the Vancouver reference style are shown below.

See our editorial policies for author guidance on good citation practice

Web links and URLs: All web links and URLs, including links to the authors' own websites, should be given a reference number and included in the reference list rather than within the text of the manuscript. They should be provided in full, including both the title of the site and the URL, as well as the date the site was accessed, in the following format: The Mouse Tumor Biology Database. http://tumor.informatics.jax.org/mtbwi/index.do . Accessed 20 May 2013. If an author or group of authors can clearly be associated with a web link, such as for weblogs, then they should be included in the reference.

Example reference style:

Article within a journal

Smith JJ. The world of science. Am J Sci. 1999;36:234-5.

Article within a journal (no page numbers)

Rohrmann S, Overvad K, Bueno-de-Mesquita HB, Jakobsen MU, Egeberg R, Tjønneland A, et al. Meat consumption and mortality - results from the European Prospective Investigation into Cancer and Nutrition. BMC Medicine. 2013;11:63.

Article within a journal by DOI

Slifka MK, Whitton JL. Clinical implications of dysregulated cytokine production. Dig J Mol Med. 2000; doi:10.1007/s801090000086.

Article within a journal supplement

Frumin AM, Nussbaum J, Esposito M. Functional asplenia: demonstration of splenic activity by bone marrow scan. Blood 1979;59 Suppl 1:26-32.

Book chapter, or an article within a book

Wyllie AH, Kerr JFR, Currie AR. Cell death: the significance of apoptosis. In: Bourne GH, Danielli JF, Jeon KW, editors. International review of cytology. London: Academic; 1980. p. 251-306.

OnlineFirst chapter in a series (without a volume designation but with a DOI)

Saito Y, Hyuga H. Rate equation approaches to amplification of enantiomeric excess and chiral symmetry breaking. Top Curr Chem. 2007. doi:10.1007/128_2006_108.

Complete book, authored

Blenkinsopp A, Paxton P. Symptoms in the pharmacy: a guide to the management of common illness. 3rd ed. Oxford: Blackwell Science; 1998.

Online document

Doe J. Title of subordinate document. In: The dictionary of substances and their effects. Royal Society of Chemistry. 1999. http://www.rsc.org/dose/title of subordinate document. Accessed 15 Jan 1999.

Online database

Healthwise Knowledgebase. US Pharmacopeia, Rockville. 1998. http://www.healthwise.org. Accessed 21 Sept 1998.

Supplementary material/private homepage

Doe J. Title of supplementary material. 2000. http://www.privatehomepage.com. Accessed 22 Feb 2000.

University site

Doe, J: Title of preprint. http://www.uni-heidelberg.de/mydata.html (1999). Accessed 25 Dec 1999.

Doe, J: Trivial HTTP, RFC2169. ftp://ftp.isi.edu/in-notes/rfc2169.txt (1999). Accessed 12 Nov 1999.

Organization site

ISSN International Centre: The ISSN register. http://www.issn.org (2006). Accessed 20 Feb 2007.

Dataset with persistent identifier

Zheng L-Y, Guo X-S, He B, Sun L-J, Peng Y, Dong S-S, et al. Genome data from sweet and grain sorghum (Sorghum bicolor). GigaScience Database. 2011. http://dx.doi.org/10.5524/100012 .

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Creative Steps to Write a Nutrition Case Study

Table of Contents

Nutrition plays a vital role in improving a patient’s health. However, each patient has unique nutritional needs requiring a personalized healthcare approach. That’s where nutrition case studies come in. These case studies comprehensively assess a patient’s nutritional status and help develop an individualized nutrition plan. They also help to monitor and evaluate the patient’s progress toward their health goals over time. In this article, we will provide a step-by-step guide on  how to write a nutrition case study . This post will help you understand the importance of nutrition case studies, whether you are a healthcare professional or a student.

What Is a Nutrition Case Study?

A nutrition case study comprehensively reports an individual’s nutritional status, dietary habits, and health outcomes . Healthcare professionals typically use these case studies to evaluate and treat patients. This is with various nutritional concerns, such as obesity, malnutrition, or chronic diseases. If you are a nutrition student or practitioner, learning how to write a nutrition case study is an essential skill to have. 

Importance of Nutrition Case Study

Nutrition case studies are a crucial tool for healthcare professionals in nutrition and dietetics. Here are some of the reasons why nutrition case studies are essential:

Provides a Comprehensive Assessment of a Patient’s Nutritional Status

 Nutrition case studies involve a detailed analysis of a patient’s dietary intake, medical history, and lifestyle factors that may impact their nutritional status. This information is used to develop a personalized nutrition plan tailored to the patient’s needs.

Develops an Individualized Nutrition Plan

A nutrition case study’s personalized approach to healthcare leads to an individualized nutrition plan. This approach can lead to better patient outcomes, improved health outcomes, and a higher quality of life for the patient.

Monitors and Evaluates Progress Over Time

Nutrition case studies track a patient’s food intake, weight, body composition, and other health outcomes over time. This enables healthcare professionals to monitor and evaluate the patient’s progress toward their health goals and adjust the nutrition plan as needed.

Provides Education About Healthy Eating Habits and Lifestyle Changes

Nutrition case studies can help educate patients about healthy eating habits and lifestyle changes. By providing a detailed assessment of a patient’s nutritional status, healthcare professionals can help patients make sustainable changes to their diet and lifestyle.

Supports Evidence-Based Practice

Nutrition case studies are based on evidence-based practice, meaning the nutrition plan is grounded in scientific research and clinical expertise. This approach ensures that the patient receives the best care based on the latest research and clinical knowledge.

Steps on How to Write a Nutrition Case Study

Selecting the patient.

The first step in writing a nutrition case study is selecting the patient. Typically, the patient has sought out nutritional counseling or treatment for a specific reason. These reasons include weight management, a chronic disease, or a food allergy. The patient should be willing to participate in the case study and provide detailed information about their diet, health history, and lifestyle habits. When selecting a patient, obtaining their written consent to participate in the case study is essential. This should include an explanation of the purpose of the case study and how their information will be used. It should also add any potential risks or benefits of participating. The patient should know that they can stop participating in the research at any moment if they don’t want to.

Gathering Information

The next step in writing a nutrition case study is gathering information about the patient. This includes a comprehensive assessment of their dietary habits, health status, medical history, and lifestyle factors that may impact their nutrition. To gather this information, you may need to conduct a nutrition assessment, which typically includes the following components:

Anthropometric Measurements

This involves measuring the patient’s height, weight, body mass index (BMI), and other body composition measures.

Dietary Intake Assessment

This involves collecting information about the patient’s dietary habits, including food preferences, allergies, and cultural or religious dietary restrictions.

Biochemical Assessment

This involves analyzing the patient’s blood, urine, or other biological samples to assess their nutritional status.

Medical History

This involves collecting information about the patient’s past and current medical conditions, medications, and surgeries.

Lifestyle Assessment

This involves collecting information about the patient’s physical activity, stress, and other lifestyle factors that may impact their nutrition status. Gathering as much information as possible is essential to create a comprehensive nutrition case study. This information will help you develop an individualized nutrition plan addressing the patient’s needs and concerns.

Developing a Nutrition Plan

Once you have gathered all the necessary information, the next step is to develop a nutrition plan for the patient. The nutrition plan should be based on the patient’s dietary needs, health goals, and lifestyle factors. It should also consider any medical conditions or medications that may impact the patient’s nutritional status. The nutrition plan should include the following components:

Macronutrient and Micronutrient Recommendations

This involves recommending specific amounts of carbohydrates, protein, fat, and other essential nutrients the patient should consume daily.

Food Group Recommendations

This involves recommending specific food groups for the patient, such as fruits, vegetables, whole grains, and lean proteins.

Meal and Snack Recommendations

This involves recommending specific meals and snacks for the patient to meet their nutritional needs throughout the day.

Nutritional Supplements

This involves recommending specific nutritional supplements, such as vitamins, minerals, or protein powders, that may help patients meet their nutritional needs.

Behavioral Recommendations

This involves recommending specific behavioral changes that may impact the patient’s nutrition status, such as increasing physical activity or reducing stress. The nutrition plan should be individualized to the patient’s needs and preferences. It should also be realistic and achievable, considering any barriers the patient may face in following the plan.

Implementing the Nutrition Plan

Once the nutrition plan has been developed, the next step is implementing it with the patient. This may involve educating the patient about healthy eating habits and strategies for making dietary changes. The patient should also be encouraged to track their food intake and monitor their progress toward their health goals. Working collaboratively with the patient throughout the implementation process is essential, as ongoing support and guidance are needed. This may involve regular follow-up appointments or communication via phone or email. The patient should be encouraged to ask questions and share any concerns or challenges they may be experiencing.

Monitoring and Evaluating Progress

The final step in writing a nutrition case study is monitoring and evaluating the patient’s progress. This involves tracking the patient’s food intake, weight, body composition, and other health outcomes. The patient’s progress should be regularly assessed, and adjustments made to the nutrition plan as needed. Objective measures such as laboratory values or body composition assessments are essential to evaluate the patient’s progress. This can help ensure that the nutrition plan is effective and that the patient is progressing toward their health goals.

How to Write a Nutrition Case Study

Once the nutrition plan has been implemented and the patient’s progress has been evaluated, it is time to write the case study. The case study should be organized in a logical and easy-to-read format, and should include the following sections:

Introduction

This should provide an overview of the patient’s case and outline the purpose of the case study.

Patient History

You should provide a comprehensive overview of the patient’s medical history, dietary habits, and lifestyle factors that may impact their nutritional status.

Nutrition Assessment

This should provide a detailed assessment of the patient’s nutritional status, including anthropometric measurements, dietary intake, biochemical markers, and medical history.

Nutrition Plan

This should provide a comprehensive overview of the patient’s individualized nutrition plan. They include macronutrient and micronutrient recommendations, food group recommendations, meal and snack recommendations, nutritional supplement recommendations, and behavioral recommendations.

Implementation and Follow-Up

This should provide an overview of the patient’s progress in implementing the nutrition plan, including any challenges or barriers encountered. It should also outline the follow-up appointments or communication that took place between the patient and healthcare provider.

This should provide an overview of the patient’s progress towards their health goals, including any changes in weight, body composition, or laboratory values.

This should provide an interpretation of the patient’s results, including any limitations or strengths of the case study. It should also provide a summary of the key takeaways and implications for future practice.

Writing a nutrition case study may not be the most exciting task in the world, but it is a crucial one. By following these steps and using a bit of wit and creativity, healthcare professionals can effectively communicate their patient’s nutritional needs . This shows progress toward their health goals. Who knows, maybe writing a nutrition case study will be more fun than you thought!

Abir Ghenaiet

Abir is a data analyst and researcher. Among her interests are artificial intelligence, machine learning, and natural language processing. As a humanitarian and educator, she actively supports women in tech and promotes diversity.

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Science Based Nutrition

Case studies.

Our case studies consist of documented information related to patients who have used the Science Based Nutrition™ blood analysis and nutritional healthcare program to assist their body in healing. Rather than using samples to examine a limited number of variables, case study methods involve an in-depth, longitudinal examination of a single instance or event.

All of our case studies:

Use objective testing to measure progress., consist of 100% drug free solutions., include an analysis by the healthcare professional., alzheimers disease.

In Just 4 months:

• Memory improving
• Anxiety and stress reduced
• Able to concentrate
• Sense of humor returning
• No longer depressed
• More animated

Ankylosing Spondylitis

In Just 3 months:

• Right knee completely healed
• Increased energy
• Off all medications
• No joint pain or stiffness
• Grew 2 inches and gaines 10lbs

Anxiety & Poor Concentration

In just 2 months:

• Night sweats nearly gone
• Excessive hunger under control
• No depression symptoms
• Off all 5 medications

Breast Cancer

In Just 2 weeks:

• Tumor marker dropped 106.9 points
• Patient refused Chemo & Radiation therapy due to outstanding results
• Blood pressure shows improvement
• Update:  CA 27.29 has dropped to 19.5!

Chronic Skin Rash

In just 3 months:

• Triglycerides dropped 88 pts
• Cholesterol dropped 43 pts
• Vitamin D levels optimal!
• Better Energy/Stamina
• Glucose dropped 13 pts

Crohn’s Disease

• Digestion under control
• Fingernails are healthy and strong
• Dermatitis gone

Diabetes and High Blood Pressure

• Triglycerides down 129 points
• Off all 6 medications
• Glucose level dropped from 274 to 120
• Thyroid showing improvement

Fibromyalgia/ Chronic Fatigue

• Liver Enzymes Within Normal Ranges
• Thyroid Steadily Improving
• Allergies Improved
• Dismissed By Neurologist
• Down To Just 1 Medication
• Thyroid Nodule Disappeared

Gout & Poor Memory

• Lost 21 lbs
• No Pain in Feet
• Memory & Concentration Improved

Kidney Cancer

In just 6 months:

• No longer needs inhaler
• Tumor has nearly stabilized
• 56 year old patient felt as good as he did at age 30

Liver Cancer

• Cancer marker PLUNGED from 4,163 to 128
• Patient can sleep through the night
• Off 2 medications
• Multiple Liver Pulmonary Nodules gone
• No growth in other nodules
• Reached a healthy weight

Lung Cancer

• Triglycerides down from 227 to 151
• Immune system strong
• Cancer markers steady
• Glucose level down from 113 to 99
• Chronic cough virtually gone

Menopause & Insomnia

• Night sweats gone
• Weight stabilized
• Stopped taking Xanax

In just 9 months:

• Anxious feelings dissipated
• Appetite returning
• Blood pressure back to normal
• Hot flashes significantly improved
• Shakiness subsided

Methicillin Resistant Staphylococcus Aureus (MRSA)

• Infections cleared
• No more pus-like discharge
• No more boils

Multiple Sclerosis

In just 5 months:

• Can walk up/down stairs
• More independent
• Vision improving
• Able to walk on toes

Parkinsons Disease

In just 4 months:

• More energy
• Can go jogging
• Less stuttering
• Started preaching again
• Emotions under control

After parasite cleanse:

• Hormone problems resolved
• No sensitivity to light

PSA/High Cholesterol

• Lost 22 lbs
• Off Cholesterol Medication
• Decreased/Stable PSA
• Blood Pressure Improved

Rosacea, Chronic Fatigue & Poor Digestion

In just 4.5 months:

• Rosacea gone
• Better digestion
• Memory and concentration improving
• Diarrhea subsided
• Anxiety significantly reduced

Viral Warts

• All warts gone
• Increase in energy

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• Open access
• Published: 09 April 2024

Creating culturally-informed protocols for a stunting intervention using a situated values-based approach ( WeValue InSitu ): a double case study in Indonesia and Senegal

• Annabel J. Chapman 1 ,
• Chike C. Ebido 2 , 3 ,
• Rahel Neh Tening 2 ,
• Yanyan Huang 2 ,
• Ndèye Marème Sougou 4 ,
• Risatianti Kolopaking 5 , 6 ,
• Amadou H. Diallo 7 ,
• Rita Anggorowati 6 , 8 ,
• Fatou B. Dial 9 ,
• Jessica Massonnié 10 , 11 ,
• Mahsa Firoozmand 1 ,
• Cheikh El Hadji Abdoulaye Niang 9 &
• Marie K. Harder 1 , 2  

BMC Public Health volume  24 , Article number:  987 ( 2024 ) Cite this article

200 Accesses

Metrics details

International development work involves external partners bringing expertise, resources, and management for local interventions in LMICs, but there is often a gap in understandings of relevant local shared values. There is a widespread need to better design interventions which accommodate relevant elements of local culture, as emphasised by recent discussions in global health research regarding neo-colonialism. One recent innovation is the concept of producing ‘cultural protocols’ to precede and guide community engagement or intervention design, but without suggestions for generating them. This study explores and demonstrates the potential of an approach taken from another field, named WeValue InSitu , to generate local culturally-informed protocols. WeValue InSitu engages stakeholder groups in meaning-making processes which ‘crystallize’ their envelope of local shared values, making them communicable to outsiders.

Our research context is understanding and reducing child stunting, including developing interventions, carried out at the Senegal and Indonesia sites of the UKRI GCRF Action Against Stunting Hub. Each national research team involves eight health disciplines from micro-nutrition to epigenetics, and extensive collection of samples and questionnaires. Local culturally-informed protocols would be generally valuable to pre-inform engagement and intervention designs. Here we explore generating them by immediately following the group WeValue InSitu crystallization process with specialised focus group discussions exploring: what local life practices potentially have significant influence on the environments affecting child stunting, and which cultural elements do they highlight as relevant. The discussions will be framed by the shared values, and reveal linkages to them. In this study, stakeholder groups like fathers, mothers, teachers, market traders, administrators, farmers and health workers were recruited, totalling 83 participants across 20 groups. Themes found relevant for a culturally-informed protocol for locally-acceptable food interventions included: specific gender roles; social hierarchies; health service access challenges; traditional beliefs around malnutrition; and attitudes to accepting outside help. The concept of a grounded culturally-informed protocol, and the use of WeValue InSitu to generate it, has thus been demonstrated here. Future work to scope out the advantages and limitations compared to deductive culture studies, and to using other formative research methods would now be useful.

Peer Review reports

Although progress has been made towards the SDG of ‘Zero Hunger by 2025’, the global rates of malnutrition and stunting are still high [ 1 ]. Over the past 20 years, researchers have implemented interventions to reduce undernutrition, specifically focussing on the first 1000 days of life, from conception to 24 months [ 2 ]. However, due to both differing determinants between countries [ 3 , 4 ] as well as varying contextual factors, it is clear that no single fixed approach or combination of approaches can be relied on when implementing stunting interventions [ 5 , 6 , 7 ]. Furthermore, when external researchers design interventions for local areas in Low- and Middle-Income Countries (LMICs) they can often overlook relevant local cultural factors that consequently act as barriers to intervention uptake and reduce their effectiveness, such as geographical factors and the levels of migration in certain populations [ 8 , 9 ], or social norms or perceptions relating to accepting outside help, and power dynamics related to gender [ 10 , 11 , 12 ]. The inclusion of cultural level factors in behaviour change interventions has been proposed as a requirement for effective interventions [ 13 ]. However, despite the breadth of literature highlighting the negative impacts from failing to do this, the lack of integration or even regard of local culture remains a persistent problem in Global Health Research [ 14 ], possibly hindering progress towards the SDGs. Thus, there is a need for approaches to integrate local cultural elements into intervention design.

This lack of understanding of relevant local culture, social norms and shared values also has ethical implications. The field of Global Health Ethics was predominantly developed in the Global North, in High Income Countries (HICs), embedding values common in those countries such as the prominence of individual autonomy [ 15 , 16 ]. Researchers from HICs carrying out research in LMICs may wrongly assume that values held in the Global North are universal [ 14 ] and disregard some local values, such as those related to family and collective decision making, which are core to many communities in LMICs. It is therefore important for outside researchers to have an understanding of relevant local values, culture and social norms before conducting research in LMICs so as not to impose values that do not align with local culture and inadvertently cause harm or offence [ 16 , 17 ]. The importance of this is compounded by the colonial history that is often present in relationships between research communities in HICs and LMICs, and the fact that the majority of the funding and leading institutions are still located in the Global North [ 18 , 19 ]. Thus, conscious steps must be taken to avoid neo-colonialism in Global Health Research [ 20 ]. From a health-equity perspective, it is essential to ensure that those in vulnerable communities are not hindered from involvement in interventions to improve nutrition. Encouraging uptake by such communities could be provided if salient local shared values, norms and culture were taken into account [ 21 ].

In a recent paper, Memon et al., (2021) highlight the usefulness of first creating a cultural protocol that can precede and guide subsequent stages of community engagement or intervention design to ensure that salient local values are known to external researchers coming into the community [ 16 ]. We adopt the use of the concept of a cultural protocol, referring to locally-generated guidance about key values, norms, behaviours and customs relevant to working with the local community. However, we prefer the term, ‘culturally-informed protocol’ since this relates to only cultural elements deemed salient by the researchers, and locally, rather than any comprehensive notion of culture, nor extending beyond the research context.

Memon et al. (2021), point out links between the creation of such a protocol and existing codes of practice that have already been created for some cultures such as the Te Ara Tika, a Guideline for Māori Research Ethics [ 22 ]. Currently, research and interventions in Global Health can be informed by a stage of formative research involving one-to-one interviews, focus groups or direct observations, which can sometimes be ethnographic in nature such as within Focussed Ethnographic Studies or Rapid Assessment Procedures [ 23 , 24 , 25 ]. Although these methods can be effective to inform intervention designs, they have disadvantages like: can take long periods to complete [ 26 ], can be resource intensive [ 26 ] and can lack cultural acceptability [ 27 ]. These limitations may account for the frequent neglect of their use generally, highlighted by Aubel and Chibanda (2022) [ 14 ]. Additionally, none of these methods work towards making explicit local values, or towards the creation of a culturally-informed protocol. In brief, the literature suggests a need to develop alternative methods of Formative Research for understanding locally relevant cultural elements, that are less time-consuming and can generate data that is more easily translatable to intervention design. In addition, these approaches must be applicable in different cultures. Additionally, the protocols produced must be actionable and practical not only for guiding interactions between research teams but also for guiding the initial stages of intervention design.

The work presented here aims to address several of these needs. It includes an exploration of the usefulness of the WeValue InSitu ( WVIS ) approach because that has previously been shown, in environmental management domains, to offer a way to gather in-depth values-based perspectives from a target population [ 28 , 29 ] It was first created through action research, and co-designed to enable civil society organisations to better understand and measure the values-based aspects of their work [ 30 ]. The core WeValue InSitu process (detailed in Table 1 ) involves the crystallization of shared values, with a facilitator guiding a group of participants with shared experiences, through cycles of tacit meaning-making (using a stage of photo-elicitation and triggering) [ 31 ], until they can articulate more explicitly their shared values, in concise and precise statements. These statements are then linked together in a framework by the participants. In an example case in Nigeria, the results of the WVIS approach hinted at the creation of a culturally-informed protocol through an analysis of the shared values frameworks to find cultural themes for the creation of an indicator tool that was used to evaluate several development scenarios based on their social acceptability [ 29 ].

Furthermore, it has been found that if a group of WVIS participants take part in a specialised focus group discussion (FGD), named Perspectives EXploration (PEX:FGD) immediately afterward the main workshop, then they easily and articulately express their perspectives on the topics raised for discussion - and with allusions to the shared values they had crystallised just prior. In an example from Shanghai, the PEX:FGDs focussed on eliciting perspectives on climate change, which were shown to be closely linked with the cultural themes existing within the shared values frameworks produced immediately prior [ 32 ]. In that case, the PEX:FGDs allowed the cultural themes generated during the main WVIS workshop to be linked more closely to the research question. Those results suggested that the WVIS plus PEX:FGD approach could be used to create a specialised culturally-informed protocol for improved intervention design.

In the study presented here, the WVIS approach was explored for the purpose of creating culturally-informed protocols to inform the planning of interventions within two localities of the UKRI GCRF Action Against Stunting Hub [ 33 ]. The work was carried out in two parts. Firstly, the WVIS main workshop was used to elicit cultural themes within the target communities, indicating key elements to consider to ensure ethical engagement. Secondly, the PEX focus group discussions focussed on life practices related to stunting which we explored for the purpose of tailoring the culturally-informed protocols to the specific purpose of improving the design of an example intervention. The Action Against Stunting Hub works across three sites where stunting is highly prevalent but via different determinants: East Lombok in Indonesia (estimated 36% of under-fives stunted), Kaffrine in Senegal (estimated 16% of under-fives stunted) and Hyderabad in India (estimated 48% of under-fives stunted) [ 34 ]. We propose that, the information about local shared values in a given site could be used to inform the design of several interventions, but for our specific exploration the focus here is a proposed ‘egg intervention’, in which pregnant women would be provided with an egg three times per week as supplement to their diet. This study proposes that identifying shared values within a community, alongside information about local life practices, provides critical cultural information on the potential acceptability and uptake of this intervention which can be used to generate culturally-informed protocols consisting of recommendations for improved intervention design.

In this paper we aim to explore the use of the WVIS approach to create culturally-informed protocols to guide engagement and inform the design of localised egg interventions to alleviate stunting in East Lombok, Indonesia and Kaffrine, Senegal. We do this by analysing data about local shared values that are crystallized using the WeValue InSitu ( WVIS ) process to provide clear articulation of local values, followed by an analysis of life practices discussed during PEX:FGD to tailor the culturally-informed protocols for the specific intervention design.

Study setting

This research was exploratory rather than explanatory in nature. The emphasis was on demonstrating the usefulness of the WeValue InSitu ( WVIS ) approach to develop culturally-informed protocols of practical use in intervention design, in different cultural sites. This study was set within a broader shared-values workstream within the UKRI GCRF Action Against Stunting Hub project [ 33 ]. The Hub project, which was co-designed and co-researched by researchers from UK, Indonesia, Senegal and India, involves cohorts of 500 women and their babies in each site through pregnancy to 24 months old, using cross-disciplinary studies across gut health, nutrition, food systems, micro-nutrition, home environment, WASH, epigenetics and child development to develop a typology of stunting. Alongside these health studies are studies of the shared values of the communities, obtained via the WVIS approach described here, to understand the cultural contexts of that diverse health data. In this study the data from East Lombok, Indonesia and Kaffrine, Senegal were used: India’s data were not yet ready, and these two countries were deemed sufficient for this exploratory investigation.

The WVIS approach

The WVIS approach is a grounded scaffolding process which facilitates groups of people to make explicit their shared values in their own vocabulary and within their own frames (details in Fig. 1 and activities in Table 1 ). The first stage of the WVIS is Contextualisation, whereby the group identifies themselves and set the context of their shared experiences, for example, as ‘mothers in East Lombok, Indonesia’. Subsequently, there is a stage of Photo Elicitation, in which the group are first asked to consider what is important, meaningful or worthwhile to them about their context (e.g., ‘being mothers in East Lombok, Indonesia’) and then asked to choose photos from a localised set that they can use as props to help describe their answer to the group [ 29 ]. After this, a localised Trigger List is used. This Trigger List consists of 109 values statements that act as prompts for the group. Examples of these values statements are included below but all the statements begin with “it is important to me/us that…”. The group are asked to choose which statements within the trigger list resonate with them, and those are taken forward for group intersubjective discussion. After a topic of their shared values has been explored, the group begin to articulate and write down their own unique statements of them. These also all begin with “It is important to me/us that…”. After discussing all pressing topics, the group links the written statements on the table into a unique Framework, and one member provides a narrative to communicate it to ‘outsiders’. The WVIS provides a lens of each group’s local shared values, and it is through this lens that they view the topics in the focus group discussions which immediately follow, termed Perspectives EXplorations (PEX:FGDs).

Schematic of the macro-level activities carried out during the WeValue InSitu ( WVIS ) main workshop session

This results in very grounded perspectives being offered, of a different nature to those obtained in questionnaires or using external frameworks [ 31 ]. The specific PEX:FGD topics are chosen as pertinent to stunting contextual issues, including eating habits, food systems and environments, early educational environments, and perceptions of stunting. The local researchers ensured that all topics were handled sensitively, with none that could cause distress to the participants. The data for this study were collected over 2 weeks within December 2019–January 2020 in workshops in East Lombok, Indonesia, and 2 weeks within December 2020 in Kaffrine, Senegal.

The PEX:FGDs were kept open-ended so that participants could dictate the direction of the discussion, which allowed for topics that may not have been pre-considered by the facilitators to arise. Sessions were facilitated by local indigenous researchers, guided in process by researchers more experienced in the approach, and were carried out in the local languages, Bahasa in East Lombok, Indonesia and French or Wolof in Kaffrine, Senegal.

Development of localised WVIS materials

Important to the WVIS approach is the development of localised materials (Table 1 ). The main trigger list has been found applicable in globalised places where English is the first language, but otherwise the trigger lists are locally generated in the local language, incorporating local vocabulary and ways of thinking. To generate these, 5–8 specific interviews are taken with local community members, by indigenous university researchers, eliciting local phrases and ways of thinking. This is a necessary step because shared tacit values cannot be easily accessed without using local language. Examples of localised Trigger Statements produced this way are given below: (they all start with: “It is important to me/us that…”):

…there is solidarity and mutual aid between the people

…I can still be in communication with my children, even if far away

…husbands are responsible for the care of their wives and family

…the town council fulfils its responsibility to meet our needs

…people are not afraid of hard, and even manual work

Study participants

The group participants targeted for recruitment, were selected by local country Hub co-researchers to meet two sets of requirements. For suitability for the WVIS approach they should be between 3 and 12 in number; belong to naturally existing groups that have some history of shared experiences; are over 18 years old; do not include members holding significantly more power than others; and speak the same native language. For suitability in the PEX:FGD to offer life practices with relevance to the research topic of stunting, the groups were chosen to represent stakeholders with connections to the food or learning environment of children (which the Action Against Stunting Hub refer to as the Whole Child approach) [ 33 ]. The university researchers specialising in shared values from the UK, and Senegal and Indonesia respectively, discussed together which stakeholder groups might be appropriate to recruit. The local researchers made the final decisions. Each group was taken through both a WVIS workshop and the immediately-subsequent PEX:FGD.

Data collection and analysis

Standard data output from the WeValue session includes i) the jointly-negotiated bespoke Statements of shared values, linked together in their unique Framework, and ii) an oral recording of a descriptive Narrative of it, given by the group. These were digitized to produce a single presentation for each group as in Fig. 2 . It represents the synthesised culmination of the crystallisation process: a portrait of what was ‘important’ to each stakeholder group. Separately, statements from the group about the authenticity/ownership of the statements are collected.

An illustrative example of one digitized Shared Values Framework and accompanying Narrative from a teacher’s group in East Lombok, Indonesia. The “…” refers to each statement being preceded by “It is important to us that…”

When these Frameworks of ‘Statements of Shared Values’ are viewed across all the groups from one locality (Locality Shared Values Statements), they provide portraits of ‘what is important’ to people living there, often in intimate detail and language. They can be used to communicate to ‘outsiders’ what the general cultural shared values are. In this work the researchers thematically coded them using Charmaz constructionist grounded theory coding [ 35 ] to find broad Major Cultural Themes within each separate locality.

The second area of data collection was in the post- WVIS event: the PEX:FGD for each group. A translator/interpreter provided a running commentary during these discussions, which was audio recorded and then transcribed. The specific topics raised for each group to discuss varied depending on their local expertise. This required completely separate workstreams of coding of the dataset with respect to each topic. This was carried out independently by two researchers: one from UK (using NVivo software (Release 1.3.1)) and one from the local country, who resolved any small differences. All the transcripts were then collated and inductively, interpretively analysed to draw out insights that should be relayed back to the Action Against Stunting Hub teams as contextual material.

The extracts of discussion which were identified as relevant within a particular Hub theme (e.g. hygiene) were then meta-ethnographically synthesised [ 36 ] into ‘Hub Theme Statements’ on each topic, which became the core data for later communication and interrogation by other researchers within the Action Against Stunting Hub. These statements are interpretations of participants’ intended meanings, and links from each of them to data quotes were maintained, enabling future interpretations to refer to them for consistency checks between received and intended meaning.

In this investigation, those Hub Theme Statements (derived from PEX:FGD transcripts) were then deductively coded with respect to any topics with potential implications of the egg intervention. Literature regarding barriers and facilitators to nutrition interventions indicated the following topics could be relevant: attitudes to accepting help; community interactions; cooking and eating habits; traditional beliefs about malnutrition; sharing; social hierarchies [ 12 , 37 , 38 ] to which we added anything related to pregnancy or eggs. This analysis produced our Egg Intervention Themes from the data.

The Major Cultural Themes and Egg Intervention Themes were then used to create a set of culture-based recommendations and intervention specific recommendations respectively for each locality. These recommendations were then combined to form specialized culturally-informed protocols for the egg intervention in each locality: East Lombok, Indonesia and Kaffrine, Senegal. The process is displayed schematically in Fig.  3 .

Schematic representation of the method of production of the culturally-informed protocol for each locality

The preparation of the localised WVIS materials at each site took 6 hours of interview field work, and 40 person hours for analysis. The 10 workshops and data summaries were concluded within 10 workdays by two people (80 person hours). The analysis of the PEX:FGD data took a further 80 person hours. Thus, the total research time was approximately 200 person hours.

The stakeholder group types are summarised in Table 2 . The data is presented in three parts. Firstly, the Major Cultural Themes found in East Lombok, Indonesia and in Kaffrine, Senegal are described – the ones most heavily emphasised by participants. Then, the Egg Intervention Themes and finally, the combined set of Recommendations to comprise a culturally-informed protocol for intervention design for each location. Quotations are labelled INDO or SEN for East Lombok, Indonesia and Kaffrine, Senegal, respectively.

Major cultural themes from frameworks and narratives

These were derived from the Locality Shared Values Statements produced in the WVIS .

East Lombok, Indonesia

Religious values.

Islamic values were crucially important for participants from East Lombok, Indonesia and to their way of life. Through living by the Quran, participating in Islamic community practices, and teaching Islamic values to their children, participants felt they develop their spirituality and guarantee a better afterlife for themselves and their children. Participants stated the Quran tells them to breastfeed their children for 2 years, so they do. Despite no explicit religious official curriculum in Kindergarten, the teachers stated that it was important to incorporate religious teaching.

“East Lombok people always uphold the religious values of all aspects of social life.”

“It is important for me to still teach religious values even though they are not clearly stated in the curriculum.” – Workshop 1 INDO (teachers).

“In Quran for instance, we are told to breastfeed our kids for 2 years. We can even learn about that ” – Workshop 3 INDO (mothers).

Related to this was the importance of teaching manners to children and preventing them from saying harsh words. Teachers stated that it was important to create a happy environment for the children and to ensure that they are polite and well-behaved. Similarly, mothers emphasised the need to teach their children good religious values to ensure they will be polite and helpful to their elders.

“Children don’t speak harsh words.”

“My children can help me like what I did to my parents”.

– Workshop 8 INDO (mothers).

Togetherness within families and the community

The Locality Shared Values Frameworks stressed the importance of togetherness, both within family and community. Comments mentioned it being important that people rely heavily on their family and come together in times of need to support each other and provide motivation. This was also important more broadly, in that people in society should support each other, and that children grow up to contribute to society. This was also reflected in comments around roles within the family. Despite women being primary care givers, and men working to finance the family, participants stated that they follow a process of consultation to make decisions, and when facing hardships.

“that we have the sense of kinship throughout our society”.

“We have togetherness as mothers”.

“For the family side, whatever happens we need to be able to be united as a whole family. We need to have the [sense of] forgiveness for the sake of the children” – Workshop 2 INDO (mothers).

Attitudes about extra-marital pregnancy

In East Lombok, Indonesia, it was essential to both mothers and fathers that pregnancy happened within a marriage, this was to ensure that the honour of the family was upheld and that the lineage of the child was clear. The potential danger to health that early pregnancies can cause was also acknowledged.

“If they don’t listen to parents’ advice, there will be the possibility of pre-marital pregnancy happening, which will affect the family [so much].

The affect is going to be ruining the good name, honour and family dignity. When the children [are] born outside [of] marriage, she or he will have many difficulties like getting a birth certificate [and] having a hard time when registering to school or family” - Workshop 4 INDO (mothers).

“ To make sure that our children avoid getting married at a very young age and moreover [avoid] having free sex so that they will not get pregnant before the marriage” - Workshop 9 INDO (fathers).

Kaffrine, Senegal

The Major Cultural Themes which emerged from the Kaffrine data are described below. As these are grounded themes, they are different than those seen in East Lombok, Indonesia.

Access to healthcare

A recurring theme amongst the groups in Kaffrine were aspirations of affordable and easy-to-access healthcare. Community health workers stated the importance of encouraging women to give birth in hospitals and spoke of the importance of preventing early pregnancy which result from early marriages. Giving birth in hospitals was also a concern for Public Office Administrators who highlighted that this leads to subsequent issues with registering children for school. Mothers and fathers stated the importance of being able to afford health insurance and access healthcare so that they could take care of themselves.

“That the women give birth in the hospital” – Workshop 11 SEN (CHWS).

“To have affordable health insurance ” – Workshop 10 SEN (mothers).

“To have access to health care ” – Workshop 3 SEN (fathers).

“It is important that women give birth in the hospital in order to be able to have a certificate that allows us to establish the civil status” – Workshop 9 SEN (administrators).

Additionally, Community health workers spoke of their aspiration to have enough supplements to provide to their community so as to avoid frustration at the lack of supply, and mothers spoke of their desire to be provided with supplements.

“To have dietary supplements in large quantities to give them to all those who need them, so as not to create frustration” – Workshop 11 SEN (CHWS).

Another aspect of access to healthcare, was mistrust between fathers and community health workers. Community health workers explained that sometimes men can blame them when things go wrong in a pregnancy or consider their ideas to be too progressive. Thus, to these community health workers the quality of endurance was very important.

“Endurance (Sometimes men can accuse us of influencing their wives when they have difficulties in conceiving)” – Workshop 5 SEN (CHWs).

Another recurring theme was the importance of having secure employment and a means to support themselves; that there were also jobs available for young people, and that women had opportunities to make money to help support the family. This included preventing early marriages so girls could stay in school. Having jobs was stated as essential for survival and important to enable being useful to the community and society.

“To have more means of survival (subsistence) to be able to feed our families”.

“To have a regular and permanent job”.

“We assure a good training and education for our children so that they will become useful to us and the community”.

“ Our women should have access to activities that will support us and lessen our burden” – Workshop 3 SEN (fathers).

It was considered very important to have a religious education and respect for religious elders. Moreover, living by, and teaching, religious values such as being hard working, humble and offering mutual aid to others, was significant for people in Kaffrine.

“Have an education in the Islamic Culture (Education that aligns with the culture of Islam)”.

“Respect toward religious leaders” – Workshop 3 SEN (fathers).

“ To organize religious discussions to develop our knowledge about Islam ” - Workshop 10 SEN (mothers).

“ Have belief and be prayerful and give good counselling to people ” - Workshop 4 SEN (grandmothers).

Egg intervention themes from each country from perspectives EXplorations focus group discussion data

Below are results of analyses of comments made during the PEX:FGDs in East Lombok, Indonesia and Kaffrine, Senegal. The following codes were used deductively: attitudes to accepting outside help, traditional gender roles, food sharing, traditional beliefs, social hierarchies and understanding of stunting and Other. These topics were spoken about during open discussion and were not the subject of direct questions. For example, topics relating to traditional gender roles came up in East Lombok, during conversations around the daily routine. Thus, in order to more accurately reflect the intended meaning of the participants, these were labelled food practices, under the “Other” theme. If any of the themes were not present in the discussion, they are not shown below.

Attitudes to accepting outside help

Few mentions were made that focussed on participants attitudes to accepting outside help, but participants were sure that they would not make changes to their menus based on the advice of outside experts. Additionally, teachers mentioned that they are used to accepting help from local organisations that could to help them to identify under-developed children.

“ We don’t believe that [the outsiders are] going to change our eating habits or our various menus ” – Workshop 3 INDO (Mothers).

Traditional gender roles

In East Lombok, mothers spoke about how their husbands go to work and then provide them with daily money to buy the food for the day. However, this was discussed in relation to why food is bought daily and is thus discussed below in the topics Other – Food practices.

Food sharing

In East Lombok, Indonesia, in times when they have extra food, they share it with neighbours, in the hope that when they face times of hardship, their neighbours will share with them. Within the household, they mentioned sharing food from their plate with infants and encouraging children to share. Some mothers mentioned the importance of weekly meetings with other mothers to share food and sharing food during celebrations.

“ Sometimes we share our food with our family. So, when we cook extra food, we will probably send over the food to our neighbour, to our families. So, sometimes, with the hope that when we don’t have anything to eat, our neighbour will pay for it and will [share with] us.” – Workshop 3 INDO (Mothers).

“Even they serve food for the kids who come along to the house. So, they teach the kids to share with their friends. They provide some food. So, whenever they play [at their] house, they will [eat] the same.” – Workshop 2 INDO (Mothers).

Understanding of stunting

The teachers in East Lombok were aware of child stunting through Children’s Development Cards provided by local healthcare organizations. They stated that they recognise children with nutrition problems as having no patience period, no expression, no energy for activities and less desire to socialise and play with other children. The teachers said that stunted children do not develop the same as other children and are not as independent as children who are the proper height and weight for their development. They also stated that they recognise stunted children by their posture, pale faces and bloated stomachs. They explained how they usually use the same teaching methods for stunting children, but will sometimes allow them to do some activities, like singing, later, once the other children are leaving.

“ They have no patience period, don’t have any energy to do any of the activities. No expression, only sitting down and not mingling around with the kids. They are different way to learn. They are much slower than the other kids .” – Workshop 1 INDO (teachers).

“ When they are passive in singing, they will do it later when everyone else is leaving, they just do it [by] themselves ” – Workshop 1 INDO (teachers).

Specific views on eggs

In East Lombok, Indonesia, there were no superstitions or traditional beliefs around the consumption of eggs. When asked specifically on their views of eggs, and if they would like to be provided with eggs, women in East Lombok said that they would be happy to accept eggs. They also mentioned that eggs were a food they commonly eat, feed to children and use for convenience. Eggs were considered healthy and were common in their house.

“ We choose eggs instead. If we don’t have time, we just probably do some omelettes or sunny side up. So, it happens, actually when we get up late, we don’t have much time to be able to escort our kids to the school, then we fry the eggs or cook the instant noodles. And it happens to all mothers. So, if my kids are being cranky, that’s what happens, I’m not going to cook proper meals so, probably just eggs and instant noodles.” – Workshop 3 INDO (Mothers).

Other important topics – food practices

Some detailed themes about food practices were heard in East Lombok, Indonesia. The women were responsible for buying and preparing the food, which they purchased daily mainly due to the cost (their husbands were paid daily and so provided them with a daily allowance) and lack of storage facilities. They also bought from mobile vendors who came to the street, because they could buy very small amounts and get occasional credit. The mother decided the menu for the family and cooked once per day in the morning: the family then took from this dish throughout the day. Mothers always washed their fruits and vegetables and tried to include protein in their meals when funds allowed: either meat, eggs, tofu or tempeh.

“ One meal a day. They [the mothers] cook one time and they [the children] can eat it all day long. Yes, they can take it all day long. They find that they like [to take the food], because they tend to feel hungry.” – Workshop 6 INDO (Mothers).

“ They shop every day because they don’t have any storage in their house and the other factor is because the husband has a daily wage. They don’t have monthly wage. In the morning, the husband gives the ladies the money and the ladies go to the shop for the food. ” – Workshop 4 INDO (Mothers).

In Kaffrine, the following themes emerged relating to an egg intervention: they were different in content and emphasis to Lombok and contained uniquely local cultural emphases.

Mothers were welcoming of eggs as a supplement to improve their health during pregnancy and acknowledged the importance of good nutrition during pregnancy. However, they also mentioned that their husbands can sometimes be resistant to accepting outside help and provided an example of a vaccination programme in which fathers were hesitant to participate. However, participants stated that the Government should be the source of assistance to them (but currently was not perceived to be so).

“But if these eggs are brought by external bodies, we will hesitate to take it. For example, concerning vaccination some fathers hesitate to vaccinate their children even if they are locals who are doing it. So, educating the fathers to accept this is really a challenge” – Workshop 11 SEN (CHWs).

Some traditional gender roles were found to be strong. The participants emphasised that men are considered the head of the household, as expected in Islam, with the mother as primary caregiver for children. This is reflected in the comments from participants regarding the importance of Islam and living their religious values. The men thus made the family decisions and would need to be informed and agree to any family participation in any intervention – regardless of the education level of the mother. The paternal grandmother also played a very important role in the family and may also make decisions for the family in the place of the father. Community Health Workers emphasised that educating paternal grandmothers was essential to improve access to healthcare for women.

“There are people who are not flexible with their wives and need to be informed. Sometimes the mother-in-law can decide the place of the husband. But still, the husband’s [permission] is still necessary.” – Workshop 1 SEN (CHWs).

“[We recommend] communication with mothers-in-law and the community. Raise awareness through information, emphasizing the well-being of women and children.” – Workshop 1 SEN (CHWs).

“The [grand]mothers take care of the children so that the daughters in-law will take care of them in return So it’s very bad for a daughter in law not to take care of her mother in-law. Society does not like people who distance themselves from children.” – Workshop 4 SEN (grandmothers).

Social hierarchies

In addition to hierarchies relating to gender/position in the family such as grandmothers have decision making power, there was some mention of social hierarchies in Kaffrine, Senegal. For example, during times of food stress it was said that political groups distribute food and elected officials who choose the neighbourhoods in which the food will be distributed. Neighbourhood leaders then decide to whom the food is distributed, meaning there is a feeling that some people are being left out.

“ It’s political groups that come to distribute food or for political purposes…organizations that often come to distribute food aid, but in general it is always subject to a selection on the part of elected officials, in particular the neighbourhood leaders, who select the people they like and who leave the others ” – Workshop 11 SEN (CHWs).

Participants explained that during mealtimes, the family will share food from one large plate from which the father will eat first as a sign of respect and courtesy. Sometimes, children would also eat in their neighbour’s house to encourage them to eat.

“ Yes, it happens that we use that strategy so that children can eat. Note that children like to imitate so that’s why we [send them to the neighbour’s house]” – Workshop 11 SEN (CHWs)”.

Traditional beliefs about malnutrition

In Kaffrine, Senegal, some participants spoke of traditional beliefs relating to malnutrition, which are believed by fewer people these days. For example, uncovered food might attract bad spirits, and any person who eats it will become ill. There were a number of food taboos spoken of which were thought to have negative consequences for the baby, for example watermelon and grilled meat which were though to lead to birth complications and bleeding. Furthermore, cold water was thought to negatively impact the baby. Groups spoke of a tradition known as “bathie” in which traditional healers wash stunted children with smoke.

“ There are traditional practices called (Bathie) which are practiced by traditional healers. Parents are flexible about the practice of Bathie ” – Workshop 1 SEN (CHWs).

Causes of malnutrition and stunting were thought to be a lack of a balanced diet, lack of vitamin A, disease, intestinal worms, poor hygiene, socio-cultural issues such as non-compliance with food taboos, non-compliance with exclusive breastfeeding and close pregnancies. Malnutrition was also thought by some to be hereditary. Numerous signs of malnutrition were well known amongst the groups in Kaffrine. For example, signs of malnutrition were thought to be a big bloated belly, diarrhoea, oedema of the feet, anaemia, small limbs and hair loss as well as other symptoms such as red hair and a pale complexion. Despite this, malnutrition was thought to be hard to identify in Kaffrine as not all children will visit health centres, but mothers do try to take their babies heights and weights monthly. The groups were aware of the effect of poverty on the likelihood of stunting as impoverished parents cannot afford food. Furthermore, the groups mentioned that there is some stigma towards stunted children, and they can face mockery from other children although most local people feel pity and compassion towards them. Malnourished children are referred to as Khiibon or Lonpogne in the local language of Wolof.

“ It is poverty that is at the root of malnutrition, because parents do not have enough money [and] will have difficulty feeding their families well, so it is the situation of poverty that is the first explanatory factor of malnutrition here in Kaffrine” – Workshop 9 SEN (administrators).

“It can happen that some children are the victim of jokes for example of mockery from children of their same age, but not from adults and older ” – Workshop 9 SEN (administrators).

Pregnancy beliefs

In Kaffrine, Senegal, there were concerns around close pregnancies, and pregnancies in women who were too young, and for home births. Within the communities there was a stigma around close pregnancies, which prevented them from attending antenatal appointments. Similarly, there were superstitions around revealing early pregnancies, which again delayed attendance at health centres.

Groups acknowledged the role of good nutrition, and mentioned some forbidden foods such as salty foods, watermelon and grilled meat (which sometimes related back to a traditional belief that negative impacts would be felt in the pregnancy such as birth complications and bleeding). Similarly, drinking cold water was thought to negatively affect the baby. Beneficial foods mentioned included vegetables and meat, during pregnancy.

“ Often when a woman has close pregnancies, she can be ashamed, and this particularly delays the time of consultation” – Workshop 5 SEN (CHWs).

“Yes, there are things that are prohibited for pregnant women like salty foods” – Workshop 11 SEN (CHWs).

In Kaffrine, Senegal, some participants spoke of a traditional belief that if a pregnant woman consumes eggs then her baby might be overweight, or have problems learning how to talk. Despite this, mothers in Kaffrine said that they would be happy to accept eggs as a supplement, although if supplements are provided that require preparation (such as powdered supplements), they would be less likely to accept them.

“These restrictions are traditional, and more women no longer believe that eggs will cause a problem to the child. But if these eggs are brought by external bodies, we will hesitate to take it.” – Workshop 11 SEN (CHWs).

“They don’t eat eggs before the child starts speaking (the child only eats eggs when he starts talking). This is because it’s very heavy and can cause bloating and may also lead to intestinal problems.” – Workshop 4 SEN (grandmothers).

Other important topics – access to health services

For the participants in Kaffrine, Senegal, accessing health services was problematic, particularly for pre- and post-natal appointments, which faced frequent delays. Some women had access due to poor roads and chose to give birth at home. Access issues were further compounded by poverty and social factors, as procedures in hospitals can be costly, and women with close pregnancies (soon after an earlier one) can feel shame from society and hide their pregnancy.

“Women really have problems of lack of finances. There are social services in the hospital; but those services rarely attend to women without finances. Even when a child dies at birth they will require money to do the necessary procedure ” – Workshop 11 SEN (CHWs).

Creation of the culturally-informed protocols

Recommendations that comprise a culturally-informed protocol for intervention design in each locality are given in Table 3 .

The Major Cultural Themes, and specific Egg Intervention Themes drawn out from only 9–11 carefully planned group sessions in each country provided a rich set of recommendations towards a culturally-informed protocol for the localised design of a proposed Egg Intervention for both East Lombok, Indonesia and Kaffrine, Senegal. A culturally-informed protocol designed in this way comprises cultural insights which are worthy of consideration in local intervention design and should guide future stages of engagement and provide a platform from which good rapport and trust can be built between researchers and the community [ 16 ]. For example, in Kaffrine, Senegal, the early involvement of husbands and grandmothers is crucial, which reflects values around shared decision making within families that are noted to be more prevalent in LMICs, in contrast to individualistic values in HICs [ 16 , 39 ]. Similarly, due to strong religious values in both East Lombok, Indonesia and Kaffrine, Senegal, partnerships with Islamic leaders is likely to improve engagement. Past studies show the crucial role that religious leaders can play in determining social acceptability of interventions, particularly around taboo topics such as birth spacing [ 40 ].

The WVIS plus PEX:FGD method demonstrated here produced both broad cultural themes from shared values, which were in a concise and easy-to-understand format which could be readily communicated with the wider Action Against Stunting Hub, as well as life practices relevant to stunting in Kaffrine, Senegal and in East Lombok, Indonesia. Discussions of shared values during the WVIS main workshop provided useful cultural background within each community. PEX:FGD discussion uncovered numerous cultural factors within local life practices that could influence on the Egg Intervention engagement and acceptability. Combining themes from the WVIS workshop and PEX:FGDs allowed for specific recommendations to be made towards a culturally-informed protocol for the design of an Egg Intervention that included both broad cultural themes and specific Intervention insights (Table 3 ). For example, in Kaffrine, Senegal, to know that the husband’s authoritative family decision-making for health care (specific) is rooted in Islamic foundations (wider cultural) points to an Intervention Recommendation within the protocol, involving consultations with Islamic Leaders to lead community awareness targeting fathers. Similarly, in East Lombok, Indonesia the (specific) behaviour of breastfeeding for 2 years was underpinned by (wider cultural) shared values of living in Islam. This understanding of local values could prevent the imposition of culturally misaligned values, which Bernal and Adames (2017) caution against [ 17 ].

There are a number of interesting overlaps between values seen in the WVIS Frameworks and Narratives and the categories of Schwartz (1992) and The World Values Survey (2023) [ 41 , 42 ]. For example, in both Kaffrine, Senegal and East Lombok, Indonesia, strong religious values were found, and the groups spoke of the importance of practicing their religion with daily habits. This would align with traditional and conservation values [ 41 , 43 ]. Furthermore, in Kaffrine, Senegal participants often mentioned the importance of mutual aid within the community, and similar values of togetherness and respect in the community were found in East Lombok, Indonesia. These would seem to align with traditional, survival and conservation values [ 41 , 43 ]. However, the values mentioned by the groups in the WVIS workshops are far more specific, and it is possible that through asking what is most worthwhile, valuable and meaningful about their context, the participants are able to prioritise which aspects of their values are most salient to their daily lives. Grounded shared values such as these are generally neglected in Global Health Research, and values predominant in the Global North are often assumed to be universal [ 14 ]. Thus, by excluding the use of a predefined external framework, we minimized the risk of imposing our own ideas of values in the community, and increased the relevance, significance and local validity of the elicited information [ 28 ].

Participatory methods of engagement are an essential step in conducting Global Health Research but there is currently a paucity of specific guidance for implementing participatory methods in vulnerable communities [ 16 , 44 ]. In addition, there is acknowledgement in the literature that it is necessary to come into communities in LMICs without assumptions about their held values, and to use bottom-up participatory approaches to better understand local values [ 14 , 16 ]. The WVIS plus PEX:FGD methodology highlighted here exemplifies a method that is replicable in multiple country contexts [ 28 , 32 ] and can be used to crystallize local In Situ Shared Values which can be easily communicated to external researchers. Coupled with the specialised FGD (PEX:FGD), values-based perceptions of specific topics (in this case stunting) can be elicited leading to the creation of specific Culture-based recommendations. This therefore takes steps to answer the call by Memon and colleagues (2021) for the creation of cultural protocols ahead of conducting research in order to foster ethical research relationships [ 16 ]. We believe that the potential usefulness of the WVIS approach to guide engagement and inform intervention design is effectively demonstrated in this study and WVIS offers a method of making explicit local values in a novel and valuable way.

However, we acknowledge that our approach has several limitations. It has relied heavily on the local university researchers to debate and decide which participant stakeholder groups should be chosen, and although they did this in the context of the Whole Child approach, it would have been advantageous to have involved cultural researchers with a deeper understanding of cultural structures, to ensure sufficient opportunities for key cultural elements to emerge. This would have in particular strengthened the intervention design derived from the PEX:FGD data. For example, we retrospectively realised that our study could have been improved if grandmothers had been engaged in East Lombok. Understanding this limitation leads to suggestion for further work: to specifically investigate the overlap of this approach with disciplinary studies of culture, where social interactions and structures are taken into account via formal frameworks.

There are more minor limitations to note. For example, the WVIS approach can only be led by a trained and experienced facilitator: not all researchers can do this. A training programme is currently under development that could be made more widely available through online videos and a Handbook. Secondly, although the groups recruited do not need to be representative of the local population, the number recruited should be increased until theoretical saturation is achieved of the themes which emerge, which was not carried out in this study as we focussed on demonstrating the feasibility of the tool. Thirdly, there is a limit to the number of topics that can be explored in the PEX:FGDs within the timeframe of one focus group (depending on the stamina of the participants), and so if a wider range of topics need formative research, then more workshops are needed. Lastly, this work took place in a large, highly collaborative project involving expert researchers from local countries as well as international experts in WVIS : other teams may not have these resources. However, local researchers who train in WVIS could lead on their own (and in this Hub project such training was available).

The need for better understanding, acknowledgement and integration of local culture and shared values is increasing as the field of Global Health Research develops. This study demonstrates that the WVIS plus PEX:FGD shared values approach provides an efficient approach to contextualise and localise interventions, through eliciting and making communicable shared values and local life practices which can be used towards the formation of a culturally-informed protocols. Were this method to be used for intervention design in future, it is possible that more focus should be given to existing social structures and support systems and a greater variety of stakeholders should be engaged. This study thus contributes to the literature on methods to culturally adapt interventions. This could have significant implications for improving the uptake of nutrition interventions to reduce malnutrition through improved social acceptability, which could help progression towards the goal of Zero Hunger set within the SDGs. The transferability and generalisability of the WVIS plus PEX:FGD approach should now be investigated further in more diverse cultures and for providing formative research information for a wider range of research themes. Future studies could also focus on establishing its scaling and pragmatic usefulness as a route to conceptualising mechanisms of social acceptability, for example a mechanism may be that in communities with strong traditional religious values, social hierarchies involving religious leaders and fathers exist and their buy-in to the intervention is crucial to its social acceptability. Studies could also focus on the comparison or combination of WVIS plus PEX:FGD with other qualitative methods used for intervention design and implementation.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request [email protected], Orcid number 0000–0002–1811-4597. These include deidentified Frameworks of Shared Values and Accompanying Narrative from each Group; deidentified Hub Insight Statements of relevant themes.

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Acknowledgements

We thank the Hub PI, Claire Heffernan, for feedback on a late draft of the manuscript.

The Action Against Stunting Hub is funded by the Medical Research Council through the UK Research and Innovation (UKRI) Global Challenges Research Fund (GCRF), Grant No.: MR/S01313X/1.

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Annabel J. Chapman, Mahsa Firoozmand & Marie K. Harder

Department of Environmental Science and Engineering, Fudan University, Shanghai, People’s Republic of China

Chike C. Ebido, Rahel Neh Tening, Yanyan Huang & Marie K. Harder

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Chike C. Ebido

Preventive Medicine and Public Health, Université Cheikh Anta Diop (UCAD), Dakar, Senegal

Ndèye Marème Sougou

Faculty of Psychology, Universitas Islam Negeri Syarif Hidayatullah, Jakarta, Indonesia

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Southeast Asian Ministers of Education Organization Regional Centre for Food and Nutrition (SEAMEO RECFON) Universitas Indonesia, Jakarta, Indonesia

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Contributions

MKH formulated the initial research question and study design. AJC developed the specific research question. Data collection in Senegal involved CCE, NMS, AHD, FBD, RNT, CEHAN and JM. Data collection in Indonesia involved RA, RK, YH and MKH. Cultural interpretation in Senegal Involved AHD, FBD, NMS, RNT and JM. Analysis involved AJC and MF. AJC and MKH wrote the paper.

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Correspondence to Marie K. Harder .

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Chapman, A.J., Ebido, C.C., Tening, R.N. et al. Creating culturally-informed protocols for a stunting intervention using a situated values-based approach ( WeValue InSitu ): a double case study in Indonesia and Senegal. BMC Public Health 24 , 987 (2024). https://doi.org/10.1186/s12889-024-18485-y

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Creating the Future of Evidence-Based Nutrition Recommendations: Case Studies from Lipid Research 1, 2, 3

Johanna t dwyer.

4 Tufts Medical Center, Schools of Medicine and Nutrition Science and Policy, and Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA;

Kristin H Rubin

5 Kraft Heinz Company, Glenview, IL;

Kevin L Fritsche

6 University of Missouri, Columbia, MO;

Tricia L Psota

7 USDA Center for Nutrition and Policy Promotion, Alexandria, VA;

DeAnn J Liska

8 Biofortis Research, Addison, IL;

William S Harris

9 OmegaQuant Analytics, LLC, Sioux Falls, SD;

10 University of South Dakota School of Medicine, Sioux Falls, SD;

Scott J Montain

11 United States Army Research Institute of Environmental Medicine, Natick, MA; and

Barbara J Lyle

12 School of Professional Studies, Northwestern University, Evanston, IL and North American Branch of the International Life Sciences Institute, Washington, DC

Strategic translational research is designed to address research gaps that answer specific guidance questions. It provides translational value with respect to nutrition guidance and regulatory and public policy. The relevance and the quality of evidence both matter in translational research. For example, design decisions regarding population, intervention, comparator, and outcome criteria affect whether or not high-quality studies are considered relevant to specific guidance questions and are therefore included as evidence within the context of systematic review frameworks used by authoritative food and health organizations. The process used in systematic reviews, developed by the USDA for its Nutrition Evidence Library, is described. An eating pattern and cardiovascular disease (CVD) evidence review is provided as an example, and factors that differentiated the studies considered relevant and included in that evidence base from those that were excluded are noted. Case studies on ω-3 (n–3) fatty acids (FAs) and industrial trans -FAs illustrate key factors vital to relevance and translational impact, including choice of a relevant population (e.g., healthy, at risk, or diseased subjects; general population or high-performance soldiers); dose and form of the intervention (e.g., food or supplement); use of relevant comparators (e.g., technically feasible and realistic); and measures for both exposure and outcomes (e.g., inflammatory markers or CVD endpoints). Specific recommendations are provided to help increase the impact of nutrition research on future dietary guidance, policy, and regulatory issues, particularly in the area of lipids.

Strategic Research Is Needed to Strengthen Future Nutrition Guidance

The intended targets of scientific research vary. Basic research focuses on fundamental knowledge and mechanisms of action or effects. In contrast, translational policy research focuses on guidance, recommendations, education, and improving program operations ( 1 ). Strategic research addresses the current situation in which “little is done to systematically link scholarship to policy” ( 2 ). Fortunately, many tools are available to help scientists link their scholarship to nutrition guidance, regulatory, and public policy.

Systematic evidence reviews play an instrumental role in the formation of nutrition guidance, recommendations, and policy decisions. Even high-quality research studies are excluded from systematic evidence reviews if they are not directly relevant to an important guidance or policy question; if they do not test a population, intervention, comparator, or outcome (PICO) 13 highly relevant to the specific question; or if essential information on them is lacking in the publication. This article provides insights with respect to these key factors by using, as an example, the evidence review on eating patterns and cardiovascular disease (CVD) from the USDA’s Nutrition Evidence Library (NEL) evidence review process for informing Dietary Guidelines Advisory Committees (DGACs). In addition, case studies focused on ω-3 FAs and industrial trans -FAs (iTFAs) highlight important issues related to research for addressing inconsistencies in conducting and reporting lipid studies, meeting evidence review criteria, and translating the research into guidance.

Key Steps in Strategic Research to Have an Impact

For research to have a substantial impact on guidance and policy, it must address a relevant question(s) and be designed, conducted, and reported with the necessary content to meet the screening criteria used in systematic evidence reviews. Although each authoritative body may follow unique systematic review criteria, they all share key elements related to relevance and quality.

Identify and test a question relevant to a specific policy or guidance gap

The first step is to identify a key research question that is relevant to a gap in dietary guidance or nutrition policy or guidance. In the Dietary Guidelines for Americans development process, each federal advisory committee not only summarizes evidence on diet and health, but also provides its recommendations on where future research should focus to inform future guideline committee decisions ( 3 ). For those who are performing research for supporting a claim about food or food components, the research should address questions specifically posed by the regulatory agency, such as the US FDA or the European Food Safety Administration (EFSA).

Consider systematic evidence-based review criteria throughout research design and conduct and in reporting results

Systematic reviews and the criteria they use are particularly important in developing food and nutrition policy and guidance. They are the basis for decision making by credible authoritative groups, including virtually all high-impact journals, as well as the FDA, EFSA, DGAC, the Academy of Medicine/Institute of Medicine, the American Heart Association, and others. For example, the USDA’s NEL includes over 130 systematic reviews, of which >100 were guided by the 2010 and 2015 DGACs. In the regulatory arena, the FDA has systematically reviewed evidence for ≥100 potential health claims, and the EFSA carried out ∼500 reviews, including both health and structure-function claims.

Attention to key criteria used by authoritative bodies when screening papers for policy and guidance decisions will maximize the likelihood of the scientist’s research being included in the review process. These include both PICO criteria and quality judgment criteria. Key elements of systematic review frameworks used by several authoritative bodies are listed in Table 1 .

Organization-specific systematic review frameworks

PICO criteria

The test population is an important and underappreciated variable in the PICO screening process that can affect whether results are considered relevant evidence with respect to specific guidance or policy decisions. Research conducted among high-risk or diseased subjects/populations would likely be of low or no relevance in an evidence review intended to inform decision making for the healthy population (e.g., health claims intended for food consumed by the general public). In the context of lipid research, conducting a study with hypercholesterolemic subjects will limit the study’s relevance for informing policy intended for generally healthy populations. Similarly, studies reporting findings on sedentary populations that spend most of their time indoors is probably insufficient for questions specific to subgroups, like military personnel who are very physically active and who often operate in extreme environmental situations. With respect to the intervention tested and comparator control, both must be relevant and have practical application to a specific policy or guidance. Intervention form (such as ω-3 FA in food compared with in supplement or drug), intake level (e.g., testing in the range of typical trans -FA intakes), and other factors related to the intervention and relevant comparison affect whether results translate to the specific question needed to develop policy and guidance.

Finally, to meet PICO criteria, the outcomes tested must include a validated health outcome or biomarker of health that is accepted by the specific organization or entity developing policy or guidance. Health outcomes, such as incidence of disease, are often considered the strongest evidence. Surrogate biomarkers (such as blood total or LDL cholesterol) are sometimes deemed to be acceptable, depending on the decision-making organization’s determination of their validity. The paucity of accepted validated biomarkers, such as inflammatory markers, is a shortcoming. More attention to the validation process and studies is needed if markers with substantial evidence for dietary influence are to become accepted surrogate outcomes by authoritative groups making policy and guidance decisions.

Quality criteria

Systematic review methods use quality criteria to determine whether evidence from a specific study is included and, if so, the strength of that study’s evidence. In evaluating the quality of each study, trained reviewers and decision makers give low quality grades or exclude studies with limitations in design and execution, inconsistency, indirectness (lack of applicability), poor description of PICO in the methods section, and imprecision (determined by number of events and confidence intervals). Although several approaches are currently in use to determine the quality of evidence in various systematic evidence review frameworks, the principles are similar ( Table 2 ). For example, randomized double-blinded clinical trials are usually considered stronger evidence than observational studies for establishing causal inference, because of less potential bias and confounding. For randomized clinical trials, a clear description of randomization procedures in the methods section of a publication is needed if it is to be scored as high quality.

Compilation of systematic review criteria and evidence grading standards 1

Tools available to help researchers not only design, but also carefully report their studies with quality criteria in mind include the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies and CONSORT (Consolidated Standards of Reporting Trials) or Jadad scales for randomized clinical trials ( 4 – 6 ). PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is intended to help authors improve the reporting of systematic reviews and may also be useful for critical appraisal of published systematic reviews ( 7 ). GRADE (Grading of Recommendations, Assessment, Development and Evaluation) considers factors necessary to have confidence in evidence review results, i.e., the quality and totality of evidence, as well as the magnitude of the effect ( 8 ).

How Evidence Reviews Were Conducted to Inform Dietary Guidelines for Americans

The NEL is comprised of systematic reviews developed within the USDA Center for Nutrition Policy and Promotion by use of a defined methodology to objectively review, evaluate, and synthesize research to answer important diet-related questions that inform federal nutrition policy and programs. The methodology to generate NEL reviews was designed to minimize bias, maximize transparency, and ensure the systematic reviews are relevant, timely, and high quality. USDA nutrition scientists use a scientifically rigorous and transparent 6-step process to review, assess, and synthesize available food and nutrition evidence to answer specific nutrition guidance gaps. Initially, a multidisciplinary research team develops a systematic review question using a PICO framework. They then search, screen, and select studies for consideration, after which they extract data and assess the risk of bias in the body of research evidence included in the analysis. Evidence is described and synthesized to develop evidence-based graded conclusion statements before making future research recommendations. To ensure objectivity, transparency, and reproducibility, each step of the process is documented in detail, and results are made available via www.NEL.gov .

Beginning in 2010 and again in 2015, the DGAC used NEL systematic reviews as a source of evidence to guide their recommendations to the USDA and the US Department of Health and Human Services on the state of science related to the Dietary Guidelines for Americans . An NEL systematic review of dietary patterns and CVD is used here to highlight critical components in each step of the NEL process and particularly the criteria used to select, evaluate, and grade the body of evidence ( 9 ). This particular evidence review is an example of how 55 research studies met the inclusion criteria such that a strong and consistent body of evidence informed dietary guidance. In using the PICO framework, the question for this review was stated as: “What is the relation between adherence to dietary guidelines/recommendations or specific dietary patterns, assessed by using an index or score, and the risk of cardiovascular disease?” The relevant population from which the evidence would be gathered was constrained to the general population aged ≥2 y in the United States or other countries with a high or very high human development index ( 10 ) who were considered healthy or at elevated chronic disease risk. Intervention exposures were defined by adherence to a dietary pattern determined by using an a priori numeric scoring system (e.g., Healthy Eating Index, Mediterranean Diet Score). The comparator was defined as low adherence to the dietary pattern or to a different dietary pattern. The evidence review considered both specific intermediary markers (i.e., triglycerides, LDL cholesterol, HDL cholesterol, hypertension, or blood pressure) and specific clinical endpoint outcomes (i.e., incidence of CVD, CVD-related deaths, myocardial infarction, or stroke). Inclusion/exclusion criteria were developed by use of these PICO criteria and standards of quality indicating study conduct and reporting. In addition, inclusions were restricted to studies published in peer-reviewed journals and, if they were controlled trials, with ≥30 participants/arm and 80% or more of the subjects completing the study.

Data from all studies meeting inclusion criteria were carefully extracted and rigorously assessed for bias and given a study-by-study quality score. Finally, the quality of the totality of evidence was graded by expert groups based on risk of bias, quantity of studies, and relevance of the subject population. The final result, as it is for all NEL reviews, was a clearly stated answer to the original question and a grade for the body of evidence. In this case, the evidence review concluded: “There is strong and consistent evidence that in healthy adults increased adherence to dietary patterns scoring high in fruits, vegetables, whole grains, nuts, legumes, unsaturated oils, low-fat dairy, poultry and fish; low in red and processed meat, high-fat dairy, and added sugars; and moderate in alcohol is associated with decreased risk of fatal and non-fatal cardiovascular diseases, including coronary heart disease and stroke (Grade I: Strong)” ( 9 ).

Understanding this review process is critical for nutrition researchers to design and report study findings that can be included in NEL systematic reviews and subsequently have a greater impact on nutrition guidance and policy. Experience to date indicates that 2 ways researchers can enhance the collective body of nutrition evidence used in dietary guidance decision-making are to minimize study bias by using valid and reliable measures consistently across all study groups and to describe study exposures in detail (e.g., dietary patterns, food components, foods, and/or nutrients) when reporting study findings. Researchers can use the gaps in the literature identified and research recommendations provided in NEL systematic reviews to inform future investigations with a high relevance to nutrition and dietary guidance.

Case Study: Use of Inflammatory Biomarkers in Developing Dietary Guidance for Fats in the Future

Current dietary advice for Americans on fats and FAs focuses on caloric intake (e.g., food sources supplying energy in excess of needs), the impact of specific fats and FAs on CVD risk (as assessed by CVD morbidity and mortality), and 3 biomarkers (i.e., total and LDL cholesterol and triglycerides). A growing body of evidence suggests that future dietary guidance for fats might be improved by broadening relevant health outcome measures to include biomarkers of inflammation ( 11 – 16 ). Several researchers and policy-making groups consider C-reactive protein (CRP), a widely used biomarker for tissue injury and inflammation, to be a useful biomarker for CVD risk ( 14 , 17 – 20 ). In addition, there is a growing body of research supporting the utility of CRP use in risk assessment for diabetes, metabolic syndrome, and morbidity and mortality of the elderly ( 21 ). The complexity of the inflammatory process, however, suggests that no single biomarker is likely to be valid under all circumstances ( 22 – 24 ). Nutrition-related human clinical trials should include measures of as many biomarkers of inflammation as possible. However, the suitability of some commonly measured biomarkers of inflammation (e.g., TNFα, IL-6) has not been adequately justified for nutrition studies with relatively healthy populations. The transient nature of their production, short half-life, and limitations in assay sensitivity collectively make gathering and interpreting data for normal healthy subjects problematic for some inflammatory biomarkers. In nutrition, and other health-related fields, there is also an urgent need to monitor the functional immune response and inflammation in a reliable and reproducible manner. In a 2014 report, Duffy et al. ( 25 ) described a newly developed whole-blood, syringe-based ex vivo immune stimulation assay system that measures dozens of inflammatory indicators in a clinically relevant context. Such an assay system could prove invaluable for monitoring the inflammatory status of human subjects; however, current high costs may limit widespread adoption.

Evidence from observational studies and clinical trials suggests that consuming diets high in trans -unsaturated FAs (TFAs) elevates low-grade inflammation ( 26 ). In contrast, the impact of other types of fats, including those rich in SFAs, MUFAs, or PUFAs on systemic inflammation, is uncertain ( 27 ). Diets rich in ω-6 PUFAs are believed to promote inflammation in part by increasing tissue arachidonic acid, a precursor to a variety of potent pro-inflammatory mediators. A 2012 systematic review of 15 randomized clinical trials, however, reported that diets rich in linoleic acid (an ω-6 PUFA) do not promote inflammation in healthy people ( 28 ). On the other hand, when ω-6 PUFAs were substituted for sugars, SFAs, or TFAs, they reduced inflammation. Results published recently from a relatively large, well-designed, prospective study showed that higher ω-6 PUFA intake in free-living adults was inversely related to CRP (4th quartile compared with 1st: β = −0.09, 95% confidence interval: −0.16, −0.01) with lower circulating CRP levels ( 29 ). Consuming a diet rich in ω-3 PUFAs has also been reported to have anti-inflammatory actions in humans, although the benefits tend to be modest, and the results tend to be inconsistent ( 30 , 31 ). A recent report from the Framingham Offspring study found that levels of 8 different biomarkers of inflammation were significantly and inversely associated with red blood cell EPA and DHA levels ( 32 ). The recent discovery of novel classes of lipid mediators derived from ω-3 and ω-6 PUFAs with inflammation-modulating activities has only just begun to be taken into account in nutrition clinical trials ( 33 ). Adopting more comprehensive FA metabolite analyses (i.e., lipidomics) is an important step in validating whether and how ω-6 and ω-3 PUFAs affect chronic inflammation in humans ( 34 , 35 ).

Finally, in addition to fats, it appears that many dietary constituents (e.g., sugars, vitamins, minerals, phytochemicals) and lifestyle factors (e.g., age, smoking, exercise) cause low-grade inflammation ( 11 , 15 , 36 ). Therefore, adopting inflammation biomarkers in future policy-making and dietary guidance recommendations will require that researchers use careful experimental design, coupled with rigorous statistical analyses ( 13 , 19 , 22 – 24 ). Importantly, such studies must be adequately powered so that covariants believed to affect the expression of inflammatory biomarkers (e.g., obesity, aging, smoking, anti-oxidant and pro-oxidant dietary constituents/nutrients) could be appropriately accounted for.

Case Study: Partially Hydrogenated Oils for Regulatory Decisions

The conduct and translation of research related to iTFAs and CVD illustrates the importance of testing relevant interventions (e.g., with respect to exposure level) against realistic comparators. A linear dose-response relation between iTFA intake and LDL cholesterol has been shown clinically for iTFA intakes >3% of total daily energy ( 37 – 41 ). Current US government recommendations call for limiting iTFA intakes, although the specific goals range from “<1% of total daily energy” to “as low as possible” ( 42 – 44 ). These recommendations are mainly based on data extrapolated from higher intake levels, with the assumption that a consistent linear relation exists throughout all iTFA exposure levels.

Dietary TFA is obtained from both ruminant sources and industrial oils (iTFAs), with a majority of iTFAs from partially hydrogenated oils (PHOs). Because of the relation with LDL cholesterol, the US FDA mandated labeling the amount of TFAs on processed food products in 2006. Subsequently, as food manufacturers reduced iTFAs to <0.5 g/serving in many foods (which rounds to 0 g on the label), mean iTFAs intake decreased from an estimated 4.6 g · person -1 · d -1 in 2003 to 1.0 g · person -1 · d -1 (∼0.5% of total daily energy) in 2012 ( 45 , 46 ). Although average dietary iTFA intakes are currently below recommended levels, FDA published a notice in June 2015 revoking the GRAS status of PHOs ( 46 ). The evidence base FDA used to determine safety assumes that any level of intake for iTFAs increases an individual’s risk of coronary heart disease in a linear fashion. Specifically, the FDA notice concluded: “there is no longer a consensus among qualified scientific experts that PHOs, the primary dietary source of industrially-produced trans -FAs, are safe under any condition of use in food.” This determination requires that manufacturers must submit food additive petitions in order to demonstrate safety and gain FDA approval for specific PHO levels and uses in food in the future.

With respect to testing relevant exposure levels, the question is whether iTFA consumption affects LDL cholesterol at the low-intake levels coinciding with current mean intakes. Linear regressions assess the “change” in LDL cholesterol associated with a change in iTFAs over a background intake level or to a comparator group intake. However, most often the comparator group’s baseline iTFA intakes are similar to current consumption levels, and therefore, these studies measure effects of levels above actual current intakes. Research is very limited on the effect of iTFAs on LDL cholesterol in the range of iTFA intakes representing current consumption patterns, presumably because conducting the large-scale trials needed to achieve statistical power at these low levels of intake is very costly.

The relation between LDL cholesterol and iTFAs at low intakes is unclear, and a clinically meaningful change may not occur until a threshold is reached. Clinical data below 3% of total daily energy intakes are limited, and the heterogeneity in study designs confounds interpretation of the data. In order to strengthen the evidence base and provide results that translate to dietary recommendations, standards for reporting intake units of iTFAs should be established. In addition, studies should define whether an iTFA-rich oil intervention is produced from a partial hydrogenation process. The FDA GRAS restriction is related to PHOs use in foods and not on TFAs in general. However, the majority of published data does not report processing details needed to distinguish the sources and types of trans -fats (iTFAs and ruminant trans -FAs), despite presumed differing biologic responses. Therefore, more details on test oil preparation, and specifically the inclusion of a partial hydrogenation process, is necessary for research to be translatable with respect to FDA status determination.

Realistic composition of comparators also requires particular attention. Studies characteristically replace iTFAs with a caloric component (primarily cis -MUFAs) that has been shown to attenuate LDL cholesterol. This substitution is unrealistic from a food functionality perspective and therefore not relevant for translating into recommendations. The choice of suitable lipid substitutions (in consultation with experts aware of current food industry practices) for iTFAs is a critical factor in translating results to real-life scenarios. For guidance and policy, studies need to test iTFAs relative to suitable alternatives for replacing PHO in the food supply and at exposure levels that reflect realistic intakes representative of current consumption patterns by the US population.

Case Study: Research Informing Dietary Guidance on ω-3 Fatty Acids

The relation between ω-3 FAs and CVD risk was graded in an NEL evidence review as “limited” to “moderate” (depending on source for ω-3 FAs) for consideration by the 2010 DGAC ( 47 ). A considerable volume of data has accumulated since 2010 on this question, yet the situation in 2015 is even less clear than previously. An updated systematic review of the evidence is currently underway by the Agency for Healthcare Research and Quality. Studies designed to test EPA and DHA as drugs, rather than nutrients, contribute to this problem because they are short-duration interventions started late in life rather than long duration food consumption studies over a lifetime ( 48 ). In addition, there is uncertainty regarding unmeasured confounding in observational studies. Efficacy depends on many PICO factors, including dose, duration of treatment, EPA/DHA balance, timing of supplement consumption, subject/patient type, use of composite endpoints, background drugs, and the dietary intake of not only EPA and DHA but also other ω-3 (and possibly ω-6) FAs as well.

Between 2009 and 2012, 9 meta-analyses reported varying conclusions ( 49 ), with the diverse findings likely being attributable to multiple issues such as the following: relatively low doses of EPA and DHA (840 mg/d or less) ( 50 – 53 ) that do not achieve cardioprotective blood levels of EPA and DHA [which requires >1500 mg/d ( 54 )], treatments lasting only 1–5 y, use of ethyl ester forms that are poorly absorbed when taken without food ( 55 ), and including subjects with established disease who are also taking multiple background drugs and who are often consuming dietary ω-3 FAs near protective levels in both treatment and control groups. Moreover, composite endpoints (e.g., combining fatal and nonfatal myocardial infarction or stroke, hospitalization for angina, etc.) can hide the effects of EPA and DHA that affect one but not other outcomes ( 56 ). Several of these factors conspire to reduce overall event rates, leaving studies underpowered to detect an effect of the intervention ( 57 ). The future of dietary guidance on ω-3 FAs depends on research that consistently overcomes limitations related to population, intervention, comparator, and outcome limitations.

None of the major ω-3 FA randomized clinical trials used a biomarker of low EPA and DHA status in subject selection criteria. Hence, even subjects with high baseline EPA and DHA levels (derived from diet and/or metabolism) could have been included in both intervention and placebo control groups. New studies should include only subjects below a predetermined blood level of ω-3 FAs (or at least adjust for baseline levels) and should track changes from baseline to control for differences in compliance. The latter can involve drop-outs (those assigned to the active agent who do not take them) and drop-ins (those assigned to placebo who start taking EPA and DHA over the counter). The “ω-3 index,” a measure of the amount of EPA and DHA in red blood cell membranes expressed as a percentage of total FAs, appears to be a sensitive biomarker of ω-3 FA status ( 58 ). The ω-3 index is thought by some to be to EPA and DHA status what a hemoglobin A1c is to glucose status: a stable measure of relatively long-term tissue levels. The resources to conduct the “optimal” EPA and DHA study enrolling tens of thousands of middle-aged, healthy subjects given >1 g EPA and DHA or placebo (and prohibited from taking other fish-oil supplements) for several decades are unavailable. Therefore it is likely that less expensive, well-conducted (albeit never-conclusive) studies will continue to serve as the basis for understanding the role of these FAs on health. Some experts believe current evidence indicates EPA and DHA are likely to benefit individuals who have low baseline ω-3 status, who consume ≥1 g EPA and DHA/d for decades (from supplements or food), and who are not on optimal drug therapy or optimally compliant with drug treatment. Future studies should be designed to overcome the limitations described here, particularly improving on inclusion criteria, forms and doses, study length, and specific health outcomes. Informed dietary guidance and policy depends on designing studies and conducting systematic reviews with respect to these PICO considerations.

Case Study: Evidence Approach to Nutrition Guidance in the US Military

The US military relies on nutrition guidance from authoritative bodies such as the National Academy of Medicine (formerly the Institute of Medicine) when establishing food policies and nutritional feeding practices. Unique occupational related physical requirements and environmental stress exposures illustrate the specificity that needs to be considered when defining these policies and how PICO decisions in designing studies ensure that research results are relevant to the intended guidance.

The occupational lifestyle of a soldier presents several unique challenges for food and food policy. The energy requirements of military personnel are often quite high because of long hours of physical work, but in combat, space for food is limited, creating the need for energy-dense meals. Under-eating is common, because eating is often restricted to brief intermittent episodes as time or situation permit. As a result, it is critically important to provide sufficient food and high-quality nutrition between combat missions to offset any energy deficit and to provide necessary nutrients to refuel and recover. All of these considerations affect the PICO factors that will be considered relevant in translating research findings into dietary guidance for this subpopulation.

Food and nutrition policy developers must also take into consideration that individual field rations, such as the ration used for troops forward-deployed Meal, Ready to Eat, require a 3-y shelf life. Although this increases the versatility of the ration, it has historically limited the types of foods and ingredients used in formulating ration menus. Dietary supplements are not a viable option either, because the bias is to use subsistence money to buy food, and historic evidence indicates that service members will more likely eat fortified foods than supplements provided in pill form. Lastly, the food costs of rations are constrained by military budgets, forcing difficult choices when new items are considered. Research designed for use by the military will be most useful if these challenges are considered in the experimental design.

The FA composition of the military diet and military rations is similar to that of the typical American diet, i.e., sufficient in ω-6 FA but providing limited quantities of ω-3 FA. Based on some evidence that dietary fat might be aggravating the inflammatory response or hindering its resolution, food-based approaches that improve the FA composition of operational rations, as well as dining hall foods, are underway.

To generate the evidence base that is needed to make military policy decisions in regards to the recommended intake of ω-3 FAs and guidance for achieving diets with the desired ω-3 FA composition, data are needed to demonstrate both efficacy and effectiveness under real-life conditions (i.e., realistic foods among relevant environmental conditions). In recently conducted studies, ω-3 FA levels and the ω-3 index were dramatically improved when traditional foods were substituted with like items but with lowered ω-6 FA and elevated EPA and DHA. Studies are now underway, within the relevant PICO context, to determine whether soldiers will consume these foods frequently enough and in enough quantity to produce meaningful improvements in ω-3 PUFA status when the foods are provided in an ad libitum multiple-choice dining hall environment.

High-quality strategic research and systematic reviews are essential for generating evidence-based nutrition guidance, policies, and regulations. Recommendations for conducting strategic research are summarized in Table 3 . Research studies designed to answer questions relevant to specific guidance, as well as systematic review PICO criteria and quality factors, are likely to substantially impact diet and nutrition guidance, regulations, and policy. Strategically considering PICO decisions with the intended target in mind (e.g., dietary guidance gap) when designing, conducting, and reporting research is likely to lead to such studies having a greater impact in strengthening future nutrition guidance.

Specific recommendations for research with greater impact on dietary guidance 1

Acknowledgments

We are grateful to Courtney McComber at ILSI North America for her administrative leadership, Ray DeVirgiliis at ILSI North America for helping to develop this as a symposium presented at the 2015 American Society for Nutrition annual scientific sessions, Dr. Dave Baer at USDA for his insights during session development and planning, and the ILSI North America Lipids Committee members for their thoughtful suggestions. All authors read and approved the final manuscript.

13 Abbreviations used: CRP, C-reactive protein; CVD, cardiovascular disease; DGAC, Dietary Guidelines Advisory Committee; EFSA, European Food Safety Authority; iTFA, industrial trans -FA; NEL, Nutrition Evidence Library; PHO, partially hydrogenated oils; PICO, population, intervention, comparator, outcome; TFA, trans -FA.