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Research recruitment flyer, what is a recruitment flyer.

A research recruitment flyer is a single-page advertisement that conveys the essential information about a clinical trial that is recruiting. Also known as a recruitment poster, it needs to comply with IRB guidelines which mandate the inclusion of several pieces of information, including the following:[ 1 ][ 2 ]

• A condensed clinical trial title and IRB study number
• Contact information of the principal investigator or facility
• Location of the clinical trial
• The objective of the study, explicitly indicating that it is a research study
• A summary of the protocol which includes the study activities and the time commitment required of participants
• Basic inclusion and exclusion criteria (eligibility criteria)

Furthermore, there are particular elements that are not permitted on recruitment flyers for ethical reasons, which include: [ 1 ][ 2 ]

• Any form of discount or coupon for the novel drug when/if it comes to market
• Any claims that imply direct benefits of the medical intervention under study
• Any claims that the device or drug under investigation is safe or effective
• Using the terms “new drug” or “new medication” without mentioning that it is an investigational product
• Using enlarged or bold print to emphasize financial compensation or incentives

Challenges faced in clinical trial recruitment efforts

When it comes to clinical research recruitment, there are several challenges faced by sponsors and sites, which together result in an estimated 85% of trials not meeting their enrollment targets (either on time or at all). These setbacks and delays represent significant monetary losses for sponsors as well.[ 3 ] This is especially unfortunate considering that surveys have shown that up to 68% of patients would be interested in participating in a clinical research study if they had more information.[ 4 ]

So why do so many studies fall short of patient accrual targets, and why is it so difficult for clinical researchers to capture the attention of eligible participants despite the general interest in participating in clinical studies? The answer involves a combination of several factors.

One significant barrier is a lack of awareness and limited medical literacy amongst the general public. The average US adult is considered to have the reading ability of an 8th grader, and, in most cases, such a person does not have the medical knowledge that would be required to fully comprehend complex research study documentation.[ 5 ] Unless a patient has a certain degree of experience dealing with a specific medical condition, medical terminology and vocabulary might go over their head.

The general lack of awareness about clinical research opportunities is backed by an NIH survey from 2020 which found that 41% of US adults did not know about the clinical trials they were eligible for.[ 6 ] There may also be a lack of awareness and diffusion within the healthcare system. The same survey indicated that only 8.9% of those surveyed had been invited to participate in a research study through a healthcare provider.[ 6 ]

Reasons why your research recruitment flyer isn’t effective

When it comes to recruitment flyers, the challenge is thus to capture the attention of eligible participants who may not be informed about or come across research opportunities otherwise. Unfortunately, lots of recruitment flyers are not designed appropriately for capturing viewers’ attention and conveying information in a clear and aesthetic manner. Some poor design choices that have hindered the effectiveness of many a research recruitment flyer include:

• Misaligned text and poor contrast (e.g., light text on light background)
• Crowded, hard-to-read text, in block paragraphs (poor use of spacing, headings, etc. to assist visual flow and summary-level comprehension)
• Unclear content that leaves too many questions unanswered
• Too much medical jargon (readers might not even understand what the study is about)
• Visually unappealing design that does not capture attention in the first place

Given the sheer volume of advertisements competing for the same spaces - physical spaces on billboards, online ads, but also space in people’s minds - minor design flaws can hinder your ad from being noticed at all. As people are exposed to more and more ads and distractions, the time they spend on any given ad is also decreasing.[ 7 ]

What makes a good research recruitment flyer?

Recruitment material needs to do more than generate interest. It needs to be effective - i.e., turn potential participants into consented participants. Research recruitment flyers should adopt a patient-centric approach, conveying essential information clearly and concisely, and with a clear call-to-action for those who determine themselves to be eligible based on the information presented.[ 8 ]

Sponsors and researchers could consider “taking off their clinical research hats” to put themselves in their target patient’s shoes, in order to best understand their motivations and then speak to their needs in a clear and direct way.

By working from this perspective, researchers will be in a better place to create more effective recruitment flyers that selectively grab the attention of eligible participants and make it easy for them to take the next steps. In the next section, we will get into specific details of recruitment flyer design.

How to design an excellent research recruitment flyer

Developing content that is relevant, understandable, and concise, and which conveys essential information about a clinical trial without being too scientific or confusing may represent a unique challenge for many researchers who may be more used to research writing.

Toning down medical language into layman’s terminology and avoiding “jargon” is a prerequisite for effectively communicating with broad audiences. There are many helpful online tools available, such as this medical dictionary , which provides plain-language alternatives for many medical terms to help you write clearer, simpler content.

With this understanding of how to approach the tone and writing style of the recruitment flyer, let’s get into the specific information that should be included in a research flyer - and how it should be included to maximize its effectiveness.

5 Questions the research recruitment flyer should answer

To understand how to recruit participants for a study, consider these five critical questions potential participants should have clear answers to after reading the research flyer:

• Who is the study for?
• What is the study about?
• Why should I care?
• What is required of me?
• How can I get more information or sign up?

1. Who is the study for?

To target the right audience right off the bat, your research recruitment flyer needs to clarify who the study is for, and the best place to do that is in the heading, the most prominent space in almost any flyer. Let’s take a look at two examples - one poor example and a better example.

• POOR: Research study investigating diabetes

This heading is not direct, as it doesn’t call out to anyone in particular. It feels more like a general announcement and may be ignored. What about diabetes is being investigated?

• BETTER: Is your type 2 diabetes under control?

In this example, it is obvious that the flyer is addressing people with type 2 diabetes. The flyer may jump out for a person with diabetes, who would then be more likely to take a moment to review the rest of the information.

2. What is the study about?

Following the heading, the flyer should explain why the clinical trial is being conducted. This should be clearly summarized in 2–3 lines maximum, and must explicitly state that it is a research study. Consider the following examples:

• POOR: We are conducting an explanatory clinical trial to try to determine if biweekly administration of the new drug AB2377 may contribute to lowering levels of biomarkers of liver inflammation in people with advanced liver cirrhosis.

Although this description is complete and only occupies three lines, it is overly wordy and contains a lot of information that is irrelevant at this preliminary contact, such as the specific experimental drug name and details about the exact health endpoints being measured. The wording is far from straightforward, and you may have also noticed that it doesn’t specify that AB2377 is an investigational drug!

• BETTER: We are conducting a research study to find out if an experimental treatment improves signs of liver health in people with cirrhosis.

By simplifying the language to make it straightforward, and removing extraneous/complicating information, this sentence is now much clearer in describing what the clinical trial is researching, in who, and how.

3. Why should I care?

From the perspective of the person reading, the flyer should provide some indication as to why they might care to actually follow the call-to-action and participate in the study.

To answer this question, it’s helpful to consider common motivations people state for participating in clinical trials, such as access to novel therapies or wanting to help others. For more ideas about why people enroll in clinical research, refer to Enrollment in Clinical Trials: Statistics and Patient Recruitment Strategies .

It’s important to remember not to promise any personal benefits or positive outcomes, as this is both misleading and unethical (such materials will not get IRB approval).

If there is any financial compensation involved, this should be mentioned without highlighting it in any special font or formatting. Let’s examine the examples below:

• POOR: By participating, you will receive access to a cutting-edge treatment that could cure your diabetes, and you will receive $500 for participation!

This line alludes to a positive outcome for participants and highlights a monetary incentive, further without clarifying stipulations, and is thus misleading and unethical.

• BETTER: By participating, you can help us in trying to find a new treatment for people with diabetes worldwide, and will be compensated $500 for your time and commitment to the entire study.

The potential benefit stated is realistic and taps into the desire to help others. Furthermore, it clearly explains that the compensation is only awarded upon completion of the entire study, and this information is not made to stick out in any way from the rest of the text..

4. What is required of me?

When potential participants make a well-informed decision to enroll in a clinical trial (i.e., they are fully aware of what it involves), they are less likely to drop out. A strong factor in this decision-making process is what is expected from them throughout the trial, including expected time commitment, travel requirements, and mandatory procedures. This information should be laid out clearly in your recruitment flyer.

Aim to capture the entire picture; focus on what is most relevant, but make it complete. Again, keep the language clear and simple, as illustrated by the contrast between these two examples:

• POOR: The study lasts 3 years, and you will undergo numerous tests and procedures at specific intervals, plus follow-up appointments.

While certainly concise, this information is far too vague, which can create confusion or even suspicion and distrust. The lack of clarity leaves room for participants to make assumptions about the research protocol, which can deter them from enrolling or lead to drop-outs when they realize it’s not what they expected.

• BETTER: You will attend one study visit at the central location every 3 months, for 3 years (12 visits in total). At each visit, your blood will be drawn, and you will be asked to answer a short (5 min) survey. After the 3-year period finishes, there will be a single follow-up call (by telephone) 4 months later.

This description eliminates confusion as it states the exact frequency of trial site visits, so participants can accurately gauge the travel requirements. It specifies what the visits involve as well, which can help build trust as study details are presented transparently right from the beginning.

5. How can I get more information or sign up?

Finally, an effective research recruitment flyer will include a clear call-to-action that guides eligible participants to contact details where they can get more information or sign up. This should be direct and avoid ambiguities.

To help people reach you and your team, provide multiple contact options, such as a phone number, email address(es), website URL(s), QR code(s), and in some cases, even tear-offs.

Consider the following examples:

POOR: For more information and to sign up or to contact the study’s principal investigator Dr. Michaels for any questions or doubts you may have, please call +1(311)999-8888 or visit https://www.participateinmycomplexclinicalresearchtrialnow.com/vjisp984rhkls8yg3khro88ysdg37778934-?khgouesef=true0[9tiwjh4

This is a run-on sentence with subpar grammar that is not entirely clear to follow. The contact information consists of only one phone number (calls only), and a very long URL that is too difficult (or even impossible) to copy accurately. Importantly, the call-to-action is not overtly clear, indicating that readers should call “for more information” “and to sign up” “or to contact the PI.”

BETTER: For further information or to sign up, call or send an SMS to Dr. Michaels at +1(311)999-8888 or visit http://www.bit.ly/3ff5

Here you have the same information but written more concisely, and with a clearer call to action (to get more information, or to sign up). The URL is shortened so that it can be written down easily, and the phone number is set up to receive text messages as well as calls.

Design: What makes a flyer look professional yet captivating?

A research recruitment flyer that clearly and concisely answers all the questions mentioned above, but which lacks attractive or magnetizing design elements will not stand out amongst other flyers. Visual cues may be the first thing that calls a reader’s attention toward the flyer. Therefore, it is important to give the flyer’s design due attention as well. Some ideas here include:

• Format text with readable fonts and uniform font sizes. Good design practices dictate a maximum of two font styles on one flyer. Check that the fonts look good, either matching closely or complementing one another in contrast.
• Use contrast wisely, by using light text colors on darker backgrounds and vice versa to improve readability.
• Separate blocks of text with empty space. A single paragraph with all of the information jammed together is not visually appealing, and is harder to skim through.
• Use images that are appealing and that relate to the content and resonate with the target audience - a picture of a cookie is not a good match for a blood sugar control study in people with diabetes.
• Leverage elements of graphic design - use well-matched color themes, shapes and lines to separate text blocks or sections, and make use of contrast, empty space, and subconscious visual cues* to create eye-catching layouts with good alignment, symmetry, and balance.

For more information about visual design elements, take a look at this resource , starting from slide 14. *To understand what we mean by visual cues, see slide 22 of the same resource.

With all these design points in mind, you can create a visually balanced research recruitment flyer that stands out and grabs viewers’ attention, but which is subsequently easy to read as well. In terms of the actual text, make sure the call to action stands out clearly, and consider using a catchy hook or clever wordplay to grab readers’ attention in the heading.

A quick word on images - Images are a vital visual component, but can be distracting if there are too many or if they are not relevant. They can even be off-putting if they are poorly edited, skewed, or of poor resolution. It is important to obtain the rights to reproduce an image, or to use royalty-free images. Popular sites for finding royalty free images that allow commercial use include Pexels , FreeImages, and FreePik.

Consider hiring an expert to design the study recruitment flyer for you

With all of these considerations in mind, designing a research recruitment flyer might seem overwhelming, especially for sponsors who are already tied up with other duties. In some cases, it may be worth contracting an expert to help in the design of your recruitment materials (or to design them for you entirely). This could be an individual or an agency who specializes in clinical trial marketing in general, or with expertise focused around design.

Outsourcing the design process allows you to focus on core responsibilities, while bringing benefits of the expertise and experience of a professional to optimize the recruitment materials. In some cases this can save you time and even money, and you could end up with a streamlined partnership you can count on for future trials and even other pieces of study material. However, it’s also worth considering whether it would be more advantageous in the long-term to work on developing this skill internally, learning and improving your ability to develop effective recruitment flyers quickly.

Don’t forget the IRB!

Don’t forget that all study material must pass IRB approval before being distributed. Ensure your research recruitment flyer follows IRB guidelines, has all the relevant information, and that you are happy with the design before submitting it for approval.

Once your flyer is IRB approved, you cannot modify it in any way without subsequent approval. If you determine that it is under-performing and decide to make changes, you will need further IRB approval.

With that in mind, it’s a good idea to consider creating a couple of versions of your recruitment flyer, submitting them as a package for approval. That way you can swap them out quickly without waiting for subsequent approval. These versions might use different images, different headings, alternative color schemes, or have entirely different designs. That’s up to you - with practice, experience, and measurable performance indicators you can monitor, you will be better able to understand what tends to work and what doesn’t work so well for your target populations.

Sample research recruitment flyer templates

There are some online resources where you can download templates and examples of good flyers, such as the websites of the University at Buffalo , University of Florida’s CTSI , and Northwestern University .

Remember that these research recruitment flyer templates are just starting points. Build on the ideas or concepts that you feel stand out using the writing and design tips we explained above, and you will be able to design good flyers that resonate with your patient population and encourage them to enroll by providing clear descriptions that empower them to make an informed decision.

The goal of effective recruitment materials is for interested prospects to contact you, after they make a personal, preliminary judgment of their own interest and eligibility. Step into your participants’ shoes to understand their needs and design a flyer that resonates with them and makes them feel empowered to embark on a new adventure in their health journey. Focus on the use of clear, direct, and simple language, laid out in a visually appealing way that facilitates comprehension and engagement.

While creating an effective research recruitment flyer requires an initial investment of time and money, it has the potential to boost recruitment numbers and help you get your study off the ground faster. As with all things, practice makes perfect, so it may take a few attempts to get it right. If you are pressed for time or feel overwhelmed, consider outsourcing the design to a professional designer who can bring their unique expertise to the table.

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Popular guides.

• Resources & Guidance

Recruitment Materials & Guidelines

• Certain restrictions apply to studies that will use or disclose Protected Health Information (PHI) in the identification and recruitment of participants.  Please review Northwestern Medicine’s Research Privacy and Confidentiality Policy and Research Recruitment FAQs .
• Some online platforms have limitations for the invitation being sent to potential participants that prevent the inclusion of all the IRB-required elements.  In that instance, document the limitation in writing for the IRB and, if the recruitment invitation links directly to an online consent that contains all the required information, the IRB may accept the briefer ad.

Required Elements

Recommended elements.

Elements That Are Not Allowed

Types of Recruitment Materials

Recruiting Where No Treatment Relationship Exists

Materials That Do Not Require IRB Review

Unacceptable Strategies

• Study title and IRB study number
• The word “research.” Make it clear that this is a research study
• “Northwestern University”
• The PI’s name
• A contact name with either a phone number or e-mail address
• Eligibility criteria, if applicable, should be noted briefly.  Especially if payment depends on meeting these criteria.  For example, “ English speaking only ,” “ Women only ,” etc.
• “ You will be compensated for your participation .”
• “ You will receive a gift card to X for [amt.] for your participation .”
• “ Participants will be compensated .”
• The amount of payment may be included but should not be the most prominent element on the page.  Compensation should not be excessive considering the nature of the project.  Payment should be stated as a range of amounts or stated as “ at least ” or “ up to ” for payments dependent on the amount of participation.

For additional guidance on recruitment materials, refer to HRP-315 WORKSHEET Advertisements (Recruitment Materials)

• Purpose of the study
• What is expected of the participant
• The time commitment
• The location where the research will take place
• Avoid phrases such as “ help needed ” or “ subjects wanted .”
• The recommended wording is “ You are invited ” or “ Participants invited .”

Elements That Are Not Allowed*

• Offers of compensation from the sponsor that would involve a coupon good for a discount on the purchase price of the product once it has been approved for marketing
• Claims that state or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent document and protocol
• Claims that the drug, biologic or device is safe or effective for the purpose under investigation
• Claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling
• Use of the term “new treatment”, “new medication”, or “new drug” in reference to a drug or device without explaining that the test article is investigational
• Use of the term “free” in reference to treatment or procedures
• Use of exculpatory language (language in the advertising whereby prospective subjects waive or appear to waive any of their legal rights)
• Use of bold or enlarged print or other means to emphasize payment or the amount to be paid

*Contact the IRB with any requests to include disallowed elements that may be appropriate within specific contexts of research.

Teaser Advertisements

For online recruitment, projects may use teaser ads placed on social media sites such as where character length is limited:

• the teaser mentions that it is a research project;
• the teaser does not use inflammatory language or misleading statements; and
• the teaser refers the potential participant to a full flyer with all the required elements

Social Media

Social media can be defined as any online and mobile resource that provides a forum for generating, sharing, or discussing ideas and content; variably grouped as online communities (e.g., patient support groups, population-specific dating services); social networking (e.g., Facebook; Twitter); professional networking (e.g. LinkedIn); content production and sharing (e.g., YouTube, Tumblr, blogs); location-based services (e.g. Tinder, Grindr); and others.

Ensure that proposed social media recruitment strategies respect all relevant ethical norms, including:

• Proposed recruitment does not involve deception or fabrication of online identities
• Research studies are accurately represented in recruitment overtures
• Proposed recruitment does not involve members of research team ‘lurking’ or ‘creeping’ social media sites in ways members are unaware of
• Recruitment will not involve advancements or contact that could embarrass or stigmatize potential participants
• Allowable for recruitment and secondary data analysis only
• Northwestern does not recognize Facebook as an approved third-party provider and the platform cannot be used to interact with participants (e.g. via interviews, surveys, or focus groups).

What is the difference between Groups and Pages in Facebook?

Pages are open forums that can be created by companies, celebrities, and brands. These are public and although only administrators of Pages can post to the account, people with personal Facebook profiles can comment on any posts or pictures. The comment feature cannot be disabled, but comments can be removed/hidden by the administrator.

Groups can be more private than Pages because the administrator has an option to choose the privacy setting. The comment feature can be managed in each group, as determined by the administrator.

• In “Closed Groups,” only those who are invited to join the group can see content shared within it. Other people on Facebook can see that the Group exists and who are members, but unable to see any information.
• “Secret Groups” are more private and no one else on Facebook can see that the Group exists except its members. The Group will not appear on the personal Facebook profile.
• “Public Groups” allow anyone on Facebook to see that the group exists and view the information that is posted, but only members of the Group have the ability to post.

Bulk E-Mail

The IRB is responsible for the review and approval of the content of bulk e-mail intended to solicit participants for a research study.  It does not oversee the sending of the bulk e-mail at Northwestern.  Investigators should ensure they are in compliance with for the use of bulk e-mail at Northwestern and the steps for obtaining approval to send bulk e-mail through the enterprise Northwestern Bulk E-mail system.

Press Releases & Interviews (Media Relations)

Federal regulatory bodies view media relations material as a form of participant recruitment and an element of the informed consent process. Media relations material includes press releases, scripted broadcasts, non-scripted interviews or information distributed on the Internet.

For more information on when to submit media relations materials and accompanying information to the IRB please see our dedicated Media Relations webpage.

Recruiting Individuals Where No Treatment Relationship Exists

NMHC Health Care Professionals or Northwestern employed Researchers who are recruiting patients where no treatment relationship exists may recruit NMHC patients as follows:

• Prior Permission to Recruit: Researchers do not need to obtain permission from an individual’s treating provider prior to recruiting the individual.
• Face-to-Face: Face-to-face contact is allowed within NMHC facilities. For this purpose, a Researcher may receive names of potential study participants from the EDW.  Where necessary, direct access to NMHC’s electronic medical records may also allowed where real-time data is required (e.g., checking patient schedules).
• Cold-Calling: Researchers who do not have a treatment relationship with an individual may contact that individual (i.e. as a potential study subject) by phone, email, or letter. Contact information for such “cold-contact” activity must be obtained from the EDW to ensure that patients who have indicated that they do not want to receive recruitment emails, letters or phone calls are not contacted.

Recruitment Materials That Do Not Require IRB Review per FDA Guidelines

• Materials given to healthcare providers intended to solicit research participants which are not given to or seen by the potential participant (e.g. “dear doctor” letters) do not require IRB review.
• Publicly intended for individuals that are not prospective participants for a particular study.
• Listing on a website – only if limited to title, purpose, protocol summary, eligibility criteria, study sites, and contact information for the investigator.

Recruitment Strategies That Are Not Allowed

• Finder’s Fees / Recruitment Incentives: Northwestern policy prohibits the acceptance or use of finder’s fees, direct recruitment incentives, or bonuses of any type to enroll study participants.
• General Ads or Flyers:  General advertisements are defined as recruitment materials that describe more than one research study.  The IRB prohibits the use of general advertisements because it is difficult to keep the information up to date due to modifications made over the life-cycle of several studies.  Advertisements must be study-specific.

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Five Tips to Improve Clinical Trial Recruitment Flyers

03 Mar Five Tips to Improve Clinical Trial Recruitment Flyers

In his 15 years as a research coordinator, the Institute of Translational Health Sciences’ Mike Donahue has spent a lot of time analyzing and designing study recruitment flyers. He recently shared with us his tips for creating a flyer that attracts potential study participants.

1. Design and write with your target audience in mind.

Before you create your recruitment flyer, you need to identify your audience. Who are you targeting? What are their interests and how do they spend their time? What images and copy will get them to look at your flyer? Ask yourself this question: why would they want to participate in your study?

If the study includes a broad age range, remember that the answer to these questions can vary by age, health history, ethnicity, and other demographic levels. Taking a moment to define your audience will make all the difference in the success (or failure) of your flyer.

2. Make it eye-catching and easy to read from a distance.

Think about the posters you see for theater or performance events. They catch your eye with color and imagery. The text is concise—a quick scan of the poster offers the major points.

This recruitment flyer from the Vaccine Trials Unit has a clear hierarchy and bold colors.

Typical content includes: name of the event and theater or performance group, a short description of the event, venue location, dates, and where to buy tickets and find more information. Your recruitment flyer should follow a similar design format.

Not a Photoshop expert? Check out Canva , a free online graphic design program. This drag-and-drop software makes it easy to create a professional-looking flyer.

Some general design tips to keep in mind are:

• Keep typefaces limited to a maximum of two per flyer.
• Use color to attract your audience and highlight the key messages.
• Use images that will resonate with your target audience. Avoid Clipart and overly posed stock photography. This list of free stock photography sites should get you started.

3. When you are writing copy, less is more.

When creating recruitment flyers, we can be tempted to write down everything about the study. But that can lead to a crowded, difficult-to-read flyer.

The goal of the flyer is to pique enough interest that interested participants call the recruitment coordinator to learn more. Then the coordinator can answer questions and fill in the blanks. Being on the phone with a potential participant is the best recruitment tool we have.

Here are some basic copy tips:

• Create a short, eye-catching headline that ties back to the study. For example, the headline “Are You Allergic to Me?” in this CATNIP study grabs attention.
• Use the words “research study” somewhere in the text. If the study involves a drug or device, the flyer should indicate that it is investigational.

The headline for this CATNIP study flyer quickly grabs readers’ attention.

• Use bulleted text to list basic participant eligibility criteria and what participation will involve, i.e., frequency of study visits, and what participants will be asked to do, and if there is compensation.
• When writing inclusion/exclusion criteria, consider how a potential participant would interpret it. You do not want eligible participants to self-select out. For example, the wording “must not be taking any medications” could cause people taking vitamins or an occasional ibuprofen to self-select out. Changing the wording to “must not be taking any prescribed medications” would help clarify this.
• Use plain language to improve readability and understanding. The PRISM Readability Toolkit can help you develop study materials that are easily understood by the general public.

What your copy should not do:

• Make unreasonable claims, such as promising health benefits.
• Mislead potential participants.

4. Write a Call to Action.

After you have explained the study, you need to add a Call to Action. What do you want the reader to do? Give them an action step. “For more information, call, email, or visit…”

If your study is posted on the recruitment site Participate In Research , you can also direct participants to that link, in lieu of having a study-specific website.

5. Create several versions of your recruitment flyer.

To reach different demographic groups within your target population, swap out the photos, try a new headline, and ask yourself the key question, “What aspects of this study will be most interesting to this audience?”

Looking for Recruitment Support?

Our Research Coordination Center staff has a wealth of experience troubleshooting recruitment challenges at the University of Washington and beyond. Our staff can help you to:

• Design effective strategies to increase enrollment and retention
• Advance a lagging recruitment timeline
• Offer flexibility for the research team and participants
• Find eligible patients quickly by engaging nurse coordinators to support screening

To learn more about hiring a part-time recruitment specialist to support your study, please visit the ITHS Research Coordination Center web page .

Just Want to Post a Study?

ITHS manages Participate in Research, a recruitment site that allows research teams to connect directly with potential participants and volunteers. Visit ParticipateInResearch.org to learn more or get started.

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Initiatives and Committees

Plan your research, join a study, content and layout guides for recruitment flyers.

Open the sample flyer to view numbered guidelines

** Per CUIMC regulated guidelines, recruitment materials must include this information.  Contact the  CUIMC IRB Office  to be sure of all CUIMC requirements, as well as case specific content. 

• Institutional IRB Requirements**  - IRB approval stamp (number & dates of approval and expiration) & IRB protocol number, date of approval and date of expiration.
• Images/Icons  - Images should be relevant and respectful of the audience. More resources on the use of images and icons available here.
• Headline  - Capture the attention of the target audience regarding the study focus. Avoid generic language such as, “Research study seeking participants.” 
• Research study title**  - You must include the full research study title, or the abbreviated study title included in the IRB application. 
• Purpose of the study**  - Briefly explain why this study is important. Participants are interested in research studies that are beneficial to their communities. Use simple language and avoid using technical or clinical terminology. Do not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol. 
• Expectation of participants** - Clearly state what participants will need to do. Use bulleted lists. 
• Eligibility** - Clearly describe basic requirements. 
• Compensation – If applicable, list this in a factual manner like all other details (do not overemphasize). List the form of payment (e.g. cash, pre-paid card), if any.
• Location** - Include the name and address of the research facility, or note what activities are over telephone or Zoom.  (Information about parking or public transportation is helpful.)
• Contact information** - Offer multiple channels: email address, phone number, website, QR code. 
• Logos  – Include logos for all partners and follow branding guidelines. (See CUIMC Branding Guidelines )
• URL and QR code  – Provide multiple ways for participants to learn more and contact the research team. QR Codes should not be the only means of getting more information and/or signing up.
• Tear-offs - Tear-offs on flyers are a preferred method for participants. Tear-offs should be at the bottom of the page, and include name of study, email and phone number. Font size 10pt or above. 

Additional guidelines on layout and content for easy to understand recruitment flyers are provided by the National Institutes of Health “ Checklist for Communicating Science and Health Research to the Public .”

Helpful Examples:

Download Sleep Study Flyer

Download Vape Study Flyer

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Recruitment. Management. Simplified.

Research & Me is a recruiting management platform and integrated suite of marketing solutions for academic, corporate, and clinical researchers.

What is Research & Me?

Research & Me is your hub for study posting, recruitment support, participant management and team collaboration - all in one simplified platform.

Smarter technology streamlines your entire recruitment process and creates a better experience for participants, while reducing administrative burdens that can hinder the success of your research.

How Does It Work?

Post studies on Research & Me to streamline the entire recruitment and management process

Reach and engage participants with included recruitment support and available custom solutions

Simplify participant retention and management with your dashboard and team collaboration tools

Research & Me for Individuals

Whether you're a student completing your dissertation, a CRA managing research studies, or a PI leading clinical trials - Research & Me for Individuals creates freedom for you to focus on the research and not the process.

Post your study for free, and streamline the recruitment process with included tools designed to r educe administrative burdens.

01   Post      02   Recruit      03   Manage

Research & Me for Organizations

Sites, CROs and academic institutions across the country use Research & Me for Organizations to facilitate the success of their researchers, while creating standardized processes with a streamlined platform.

Powering Research For Students And Academic Institutions

For over two decades, Research & Me has helped facilitate the success of thousands of students and academic institutions across the United States.

Create Your Free Research Recruitment Flyer Today

Quickly create custom research recruitment flyers with an optional custom URL, a private email and a unique QR code to help protect your privacy - all for free.

Research & Me Marketplace Services

The Research & Me Marketplace offers custom marketing and recruiting solutions to accelerate recruitment. Our in-house marketing team will build tailored strategies to help achieve your enrollment goals.

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Research Study Flyer Templates

Encourage participation in a research study by using one of the templates below. This simple, easy-to-read format works well for distribution across campus and the community. 

MS Word Flyer Templates

Download the templates below and select between a master brand or brand extension version. Each one is available in 8.5" x 11" and 8.5" x 14" with tear-offs, and in 8.5" x 11" without tear-offs. Fill in the blanks with your information, but do not add photography. Please reference the tip sheet when creating your flyer.

Master Brand, 8.5" x 11", No Tear-Offs

Master Brand, 8.5" x 11", Tear-Offs

Master Brand, 8.5" x 14, Tear-Offs

Logistics Flyer Template

Once study participants are selected, it's important to communicate effectively and provide important, logistical information in a consistent, professional manner. The following templates are available to easily adjust location, contact information, maps, etc. for each study.  

Template Options:

Master Brand, 8.5" x 11"

North Campus map

South Campus map

The University at Buffalo is committed to ensuring digital accessibility for people with disabilities. We are continually improving the user experience for everyone, and applying the relevant accessibility standards to ensure we provide equal access to all users. If you experience any difficulty in accessing the content or services on this website, or if you have suggestions about improving the user experience, please contact:

University Communications at [email protected] or 716-645-6969 

Flyer Generator

We need your help!

More about this study, who can participate.

• Adults aged 18+
• Located in the United States

What can I expect?

• 3 in-person sessions
• Transportation provided

Just one more thing...

We're excited to host your study on the Research & Me platform. Since you selected a hosted Research & Me we need your email address to create your free Research & Me account. We will notify you via email when participants have registered and are awaiting your review.

Please provide your work, school, or organization email address. You'll be able to set a password later. If you have one, you can also provide your organization code to take advantage of extra features.

Research & Me Hosting and Individual Plus

If you don't have a webpage for your study, you're missing out on potential participants. While some will email or call you, our years of experience show that many participants prefer self-service registration. When you host your study on Research & Me, you get a study webpage, screening questionnaire, participant management tools, and much more, all for free.

For a limited time, when you choose to host your study on Research & Me, you'll receive Individual Plus for free, a $59 value. Extra survey questions, social media promotion, and more, to kickstart your recruiting and eligibility screening.

And, if you choose to host on Research & Me, you can take advantage of Marketplace services, including email distribution to our participant database, custom digital marketing campaign design, and more. We help ensure that you recruit quickly, screen efficiently, and complete your study on time.

Still have questions? Contact us today, we're happy to help you get started.

Participation Type

If your participants need to visit an office, site, or other location, it is considered "In Person".

If participation is done remotely (via phone, computer, mail, etc), it is considered "Remote / Virtual".

About Markdown

Markdown is a simple way to add basic formatting to text, like emoji, bullets, numbering, and more. Click "Learn More" for examples of Markdown syntax and formatting.

Website Help

Research & me hosted website.

Research & Me can host your study for free. Use the custom link to send participants to your dedicated study page, where you can customize a questionnaire to screen candidates. Streamline the entire recruitment process with our management and collaboration tools - all for free. Your study is only available through the links you provide, unless you choose to use optional recruitment services from Research & Me.

Your Research & Me hosted study page and custom URL will be generated once you create your flyer. If you provide an organization code, your hosted study will be added to your organization and you'll have immediate access to organization features and discounts.

Custom Website URL

If you already have a website, survey link, or other URL for this study, you can provide it instead.

Email Address Help

Research & me hosted email address.

If you’re not protecting your identity with anonymous contact information, you’re putting your privacy at risk by publicly listing your work or personal contact information. Use a free hosted address from Research & Me to protect your privacy and automate study registrations. Participants who email your hosted address are automatically added to your list of candidates and sent your customized screening questionnaire, saving you time and making intake more efficient.

Your Research & Me hosted email address will be generated once you create your flyer. If you provide an organization code, your hosted study will be added to your organization and you'll have immediate access to organization features and discounts.

Custom Email Address

Provide your own email address where potential participants can contact you directly to register for this study.

Phone Number Help

Custom phone number.

Provide a phone number where potential participants can contact you directly to register for this study.

QR Code Help

A QR Code makes it easy for participants to visit your website, send you an email, or call your phone number. When participants scan the QR Code with their phone's camera, your desired contact method will automatically pop up -- no typing necessary!

Select the contact method to use for the QR Code and it will be generated once you create your flyer.

Help: Creating Your Flyer

Help: what does it mean to post a study.

As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.

The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.

ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.

Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).

eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).

Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.

Ethics & Compliance

You are here, recruitment flyer.

(Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.

Our research

Recruitment posters, flyers and videos

People often find out about research by seeing posters or flyers asking participants to take part in a study. This page has examples of posters and flyers that have been used to recruit participants into studies. Top 5 tips for creating a recruitment flyer:

• State who can participate. Clearly state the details of those who can take part. Sometimes this can be made clearer using bullet points or a series of questions for participants to check if they are eligible.
• Make it visually appealing. Use few words and simple language. Avoid visual clutter.
• Check accessibility. Use a font that is easily readable and make it large enough to read. Use colour blind safe colours and ensure high contrast against the background.
• Print or digital? If you are making a flyer to print out and distribute, within the flyer include the text and any relevant links for participants to get more information or to sign up to take part. If you are making a flyer to post on social media or in an email campaign, do not include too much text or any links in an image file - instead place them in the main body of the social media post or the email so they can be clicked on.
• Include one call to action. Provide one clear action you want prospective participants to take, for example, to send an email to express interest, to complete an online expression of interest form or to take part in the online study.

Download example documents

Recruitment flyer.

Created by Dr Sarah Bargiela and colleagues at UCL

Recruitment poster

Created by Dr Maggi Laurie at DART, The University of Edinburgh

Study information video

Created by Jana Brinkert et al. at CRAE UCL

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Use This Sample Recruitment Email for Your Next Research Study

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Whether you’re a seasoned researcher or new to the field, clinical trial recruitment is hard. There’s no doubt about it.

Most researchers focus on creating recruitment flyers, radio and TV advertisements, maybe even trying their hand at online advertising as well. As a result, they don’t realize they already have an invaluable recruitment asset – their participant database.

Participant databases are full of people who have already expressed interest in participating in a research study. All too often, this tool gets overlooked and in the end, this can lead to dire consequences for your study.

Want access to a free downloadable template for your recruitment emails? Click here.

The answer to research recruitment woes: Maximizing your participant database

As they prepare for a new clinical trial or health research study and begin planning for recruitment, most researchers immediately gravitate toward “traditional” recruitment methods of putting up flyers, buying radio and TV ad spots, or relying on word-of-mouth. What they fail to realize, however, is that they often have an invaluable tool already at their disposal: Email.

When anyone signs up for something these days, they’re asked for an email address. This seemingly insignificant line on your intake form is arguably the most valuable piece of information you have about your study participants or clinic patients.

Table of contents

Why emailing your participant database works How to write effective recruitment emails Sample recruitment email for research study Email can positively impact your recruitment Getting help from the experts

Why emailing your patient database works

Email is potentially the single most valuable piece of information you have about potential participants. All too often, researchers overlook this fact or assume they don’t actually have a database to pull from.

You may think you don’t have an email database or that you don’t have access to one, but chances are you do. If you’ve completed previous studies, you surely have a list of your participants in your files with contact information including their email addresses. 

Even if you don’t have your own list, you likely have somewhat easy access to someone else’s. Perhaps you work with a clinic that has a patient list or your university is willing to include information about your study in a newsletter. 

If you stop and think for a moment, you may suddenly realize you have access to more email inboxes than you’d imagined.

Here’s why obtaining email addresses matters and why emailing your database works for study recruitment.

You have complete control over your list of email addresses.

First, unlike your followers on social media or other external platforms, you literally own your email list. Your patients and study participants have willingly given you their email addresses for free and you are in control of how you use that information. 

This means you can email at any time without any specific restrictions or requirements made by online or traditional advertisers and – here’s the best part – you can do it essentially for free.

You’re reaching out to a group of individuals who likely know or recognize you.

Secondly, your email list is a group of what advertisers and marketers call “ warm leads. ” This means they know you or your work. Therefore, they’re more likely to stop and look at whatever it is you’re sending. 

Even in an inbox full of emails, when your participant candidates recognize your “from” name or something in the subject line of your email, they’re more likely to open the message and take a look.

When you’re advertising to a “cold” list of leads on social media or via traditional recruitment methods, you lose out on this attention-grabbing phenomenon.

How to write effective recruitment emails

Your most valuable recruitment asset is your email list database – hands down. That being said, in order to connect with your participants, you need to think like them.

To maximize the effectiveness of your email, use the Participant Perspective Model to craft your message. 

Here are 4 important key elements to include.

1. A catchy subject

The first place you’ll catch your participants’ attention is in your subject line. If your study doesn’t already have a catchy title, take a little more liberty to try crafting a more clever subject line for your email. 

After all, this is the smallest component of your message. You don’t need to include a lot of information here – that will come later.

2. Need-to-know details about your study

To get started, make a list of points to explain your study, what’s involved, and why someone might participate. 

We’ve found the best way to do this is to sum up your study in approximately 20-50 bullets that describe your trial. As you create your list, do your best to avoid jargon when possible and try to write in a conversational tone. Remember that you’re writing this to communicate with people outside your field, not other clinicians. 

Be clear about who, specifically, is eligible to participate. Moreover, help candidates understand why they should participate if they’re eligible and the greater impact their participation will make in the long-run.

Finally, revisit the Participant Perspective Model to improve those bullet points and descriptions.

3. Clean up your letter

Use your list of cross-checked bullet points and reformat them into a letter. This will be your email body. 

For clarity, you may choose to leave some bullets in your letter so candidates can see participation eligibility points at a glance and quickly determine if they’re right for the study. However, the majority of your email should be an actual letter.

If you have one, attach a digital copy (PDF or other image-format file) of your recruitment flyer or information sheet. This will help you make your case for why participants should join the study if they’re eligible and may also help explain the study procedures.

4. Conclude with a clear action

Finally, include a link (again, if you have one) to your online prescreening questionnaire. Make it as easy as possible for your recipients to get in touch if they’re interested. 

If you don’t have a link, be very specific about what action recipients should take to get involved in your study. There should be a single action to avoid any confusion.

Sample recruitment email for research study

Subject Line: Do mealtimes matter?

Subhead: You can contribute to Diabetes Research

Our team has been working on a new research study and we need your help.

Our goal of this new study is to see if consuming food within a smaller window of time during the day can help regulate glucose levels in people with Type 2 Diabetes.

If we are able to regulate the glucose levels with diet, managing the symptoms of Type 2 Diabetes will be a bit easier and could also potentially reduce the risk of future disease development for people across the globe.

Would you like to help? To see if you are eligible, please read the requirements below.

Why You Should Participate:

• You may experience an improvement in type 2 diabetes symptoms.
• You will be reimbursed $250 in supermarket vouchers.
• You will receive individual results from glucose monitors worn for the six-week study.
• You will be provided a detailed dietary analysis that could be helpful in managing symptoms of diabetes.
• You will be helping to advance medical research.

Who Can Participate?

• Men and women aged between 35-65 years old
• Those who have been diagnosed with Type 2 Diabetes and are taking up to 2 medications (not including insulin)
• Those who are NOT currently on a strict diet regimen (i.e. vegan, coeliac/gluten-free, ketogenic)
• Those able to attend 8 study visits at the research site over approximately 7 weeks

If you fit these requirements and are interested in helping, sign up for the study by clicking the link here.

Please let me know if you have any questions we could answer. Thank you for helping to improve the lives of people with Type 2 Diabetes.

Best, Dr.Alyson Kellar ABC Health Sciences

If you need some help crafting your message, download our fill-in-the-blank email template .

BONUS: Test different emails and follow up

In the world of email marketing, there’s also consistent research happening. It’s common knowledge that some emails perform better than others. This is why email marketers engage in something called “ split-testing .”

Get into the habit of split-testing. Create two different emails by altering either the subject line or the information in your letter. Then send each of your two emails to opposite halves of your list (one email to 50% of your list and the other email to the other 50%) and compare your results. Look for your open rate and response or click-through rate if you’ve linked to your prescreening questionnaire. 

If you have a large database, you can test your emails even further. Start by sending both email versions to 10-20% of your list and determine which one is performing better – either by open rates or, ideally, click-through rate (to your prescreening questionnaire) or next-step responses. Then, send the version that’s performing better to the rest of the database. This can also be a nice way to space out your responses so you can follow up with them all promptly.

If you’re not already set up with one, using an email provider platform like Mixmax will help you track all your statistics. In many cases, these services can be used for free. Avoid platforms like MailChimp and Mailerlite to get better open rates and avoid your email being pushed into the “promotions” inbox in email service providers like Gmail.

Using email platforms like Mixmax allow you to track and optimize the emails you send to your participant database.

Finally, make sure to follow up with your email recipients if you’re able to send more than one initial email. This crucial step is often overlooked or under-appreciated by researchers. Remember how many views you need just to get a single participant enrolled to a study? Following up with a second email will help you get one step closer to full enrollment.

Email can positively impact your recruitment

So many studies – more than 85% of them – are delayed due to poor enrollment . It’s not difficult to see why when you consider that many researchers are using ineffective recruitment methods and forgetting the value of their own databases. 

While the “old school” methods of creating recruitment flyers and using traditional media to run advertisements used to work, it’s actually been outdated for years. With the growing competition of studies and the fight for all consumers’ attention – not to mention the amount of time and effort these advertisements require to create – the old methods simply aren’t effective anymore.

If you have access to a database of potential candidates that have expressed interest in participating in research, you have an invaluable tool at your disposal. Don’t wait – use it!

With so much competition for our attention, it’s also hard to stand out. Whether you realize your advertising shortcomings or not, leveraging the expertise of marketing specialists will lead to a better study with higher recruitment rates and stronger results.

Effective promotional material, like emails to your patient and participant database, will give you more time to focus on your research, keep your study on track, make progress and finish on time (or even ahead of schedule!), develop a better track record, and ultimately do more important and novel research.

Alternatively, if you’re dead-set on doing recruitment yourself, be sure to consult the Participant Perspective Model. This will help you ensure you’re on the right track and communicating effectively with your candidates.

Getting help from the experts

Looking for some help? We’re here! Researchers are often surprised that our recruitment service is within their budget and, in the long run, actually saves them both time and money. 

No matter the size of your study, we’ll put together a solid recruitment plan for your trial. There’s never any cost or obligation for your plan – it’s our gift to you. 

Leave your trial promotion to the experts so you can focus on your world-class research. Don’t waste any more time (or funding) trying to go it on your own.

Which Social Media Platform Should I Use to Recruit for My Clinical Trial?

Does Social Media Recruitment Make Sense for My Clinical Trial?

Beginner’s Guide to Using Facebook Advertising for Patient Recruitment

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We’ll undergo our due diligence process and determine how many patients we can provide for your study (guaranteed).

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Notes on Recruitment Materials

Recruitment Materials & Guidelines

Recruitment materials should include:  

• The title of the study
• The TC IRB protocol number
• An accurate description of the research purpose 
• Any eligibility criteria
• The name and contact of the investigator or facility (including university affiliation and/or department)
• A description of the risks and benefits
• The time commitment(s) required
• The amount of compensation (if applicable) and criteria for earning the compensation
• The location of the research

Recruitment materials should not include: 

• Coercive language
• Claims that a device or drug is safe and effective
• The words “new treatment,” “new medication,” or “new drug” if the test article is investigational
• Promises of “free medical treatment”
• Amount of payment, dollar signs, or the words “free” in large or boldface type
• Excessive compensation relative to the nature of the project
• Statements or implications assuring favorable outcomes or other benefits beyond what is outlined in the consent document and protocol
• Claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other test, procedure, drug, biologic, or device
• Exculpatory language

Notes on Recruitment Types

• Media advertising is intended to solicit participation in a study, and is not necessarily an objectionable practice.
• Direct advertising for study subjects is often viewed as the start of the informed consent and subject selection process. 
• IRBs review direct advertising to assure that it is not unduly coercive and does not promise a certainty beyond what is outlined in the consent form and the protocol, especially when research may involve subjects who are likely to be vulnerable to undue influence.
• Advertisements to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest in the study. 
• IRBs review the final copy of recruitment materials to evaluate the messaging, readability, and other visual effects. 
• The IRB should assure that the recruitment procedures followed adequately protect the rights and welfare of the prospective subjects. 
• Researchers should adhere to the approved recruitment methods.
• If researchers plan to change recruitment methods, they should notify the IRB through a minor modification.

Public vs. Private Recruitment

During the recruitment process, researchers should be considerate of whether they are recruiting in public establishments versus private spaces, as recruitment in non-public spaces may be subject to additional requirements. This applies to both in-person and online recruitment. The table below provides some examples of recruitment in public and private spaces.

Some online spaces (e.g., forums) may be visible to the public, but participation requires the user to meet certain criteria or have a specific role. These space are considered private spaces. This includes Facebook groups in which an administrator confirms you have a certain quality that allows you to be part of the group once terms of use are agreed to (e.g. “You must be a resident of Morningside Heights to be a part of this group”). If you are a part of a private group under a different role (e.g., Morningside Heights resident), you may not be able to post your recruitment materials for research purposes unless you disclose your researcher status to the moderators and group prior to posting. For private groups, it is always best to ensure you have full permission from the moderators to post as a researcher. In general, TC IRB recommends these three steps when looking to recruit in private digital spaces:

• Review the space's Terms of Use. 
• Contact the moderators/administrators of the space and ask for permission to post or engage with the group.
• Lastly, announce yourself as a researcher to be clear of your role in the group.

For samples of recruitment flyers, please follow the link for templates and find the downloadable document with IRB adminstrator comments and considerations:

• IRB Recruitment Flyer Templates
• IRB Recruitment Flyer Template (Example)
• For additional resources, please visit the Office for Human Research Protections printable information page .

For samples of recruitment letters and scripts, please download the following documents:

• Participant Recruitment Letter Template
• Participant Recruitment Script Template

Lastly, please find our additional information in our  Participant Recruitment Guide .

Institutional Review Board

Address: Russell Hall, Room 13

* Phone: 212-678-4105 * Email:   [email protected]

Appointments are available by request . Make sure to have your IRB protocol number (e.g., 19-011) available.  If you are unable to access any of the downloadable resources, please contact  OASID via email [email protected] .

SHARE The Study to Help the AIDS Research Effort

• Who's Who at SHARE
• Useful Links
• Recruitment
• Contributions

Recruitment Flyer

SHARE (Study to Help the AIDS Research Effort) is recruiting. HIV-negative and HIV-positive MEN

For the first time in 19 years, the SHARE study is recruiting new participants.  SHARE is part of the longest-running and largest HIV research study in the U.S.  This is a unique opportunity to contribute to the knowledge of HIV infections and HIV therapy over a lifetime.   SHARE is NOT a treatment study and does NOT involve taking experimental medicines .  You will continue to receive your medical care from your own medical care provider. 

WHO’S ELIGIBLE

• Males 30 years of age or older

WHAT’S INVOLVED

• 2  initial  visits: 

Screening visit – an initial screening visit about 30 minutes long.   If you are eligible, you will be given an appointment for an enrollment visit.

Baseline Enrollment visit – a full visit about 2-3 hours long and includes $100 compensation for your time and effort.

• Remote or in-person interviews
• Lab testing (for HIV, viral load, and other infections like hepatitis)
• Physical exams and health referrals

BENEFITS OF JOINING

• Help researchers better understand HIV and AIDS and the long-term effects of HIV medicines
• Free and confidential laboratory testing (includes T cell count and viral load)
• Free physical exams and health referrals
• Flexible scheduling, including evenings and weekends in Baltimore or DC
• A friendly, supportive environment with light refreshments

To volunteer or for more information, please contact the SHARE study at 410-955-7090 or 1-866-392-8991 or 202-745-6137.  

Principal Investigator:  Joseph Margolick, MD, PhD and Todd Brown, MD, PhD, Johns Hopkins Bloomberg School of Public Health

• Open access
• Published: 22 May 2024

Feasibility and acceptability of a cohort study baseline data collection of device-measured physical behaviors and cardiometabolic health in Saudi Arabia: expanding the Prospective Physical Activity, Sitting and Sleep consortium (ProPASS) in the Middle East

• Abdulrahman I. Alaqil   ORCID: orcid.org/0000-0003-0458-2354 1 , 2 , 3 ,
• Borja del Pozo Cruz   ORCID: orcid.org/0000-0002-9728-1317 2 , 4 , 5 ,
• Shaima A. Alothman   ORCID: orcid.org/0000-0003-2739-0929 6 ,
• Matthew N. Ahmadi   ORCID: orcid.org/0000-0002-3115-338X 7 , 8 ,
• Paolo Caserotti 2 ,
• Hazzaa M. Al-Hazzaa   ORCID: orcid.org/0000-0002-3099-0389 6 , 9 ,
• Andreas Holtermann   ORCID: orcid.org/0000-0003-4825-5697 3 ,
• Emmanuel Stamatakis 7 , 8 &
• Nidhi Gupta 3  

BMC Public Health volume  24 , Article number:  1379 ( 2024 ) Cite this article

4 Altmetric

Metrics details

Physical behaviors such physical activity, sedentary behavior, and sleep are associated with mortality, but there is a lack of epidemiological data and knowledge using device-measured physical behaviors.

To assess the feasibility of baseline data collection using the Prospective Physical Activity, Sitting, and Sleep consortium (ProPASS) protocols in the specific context of Saudi Arabia. ProPASS is a recently developed global platform for collaborative research that aims to harmonize retrospective and prospective data on device-measured behaviors and health. Using ProPASS methods for collecting data to perform such studies in Saudi Arabia will provide standardized data from underrepresented countries.

This study explored the feasibility of baseline data collection in Saudi Arabia between November and December 2022 with a target recruitment of 50 participants aged ≥ 30 years. Established ProPASS methods were used to measure anthropometrics, measure blood pressure, collect blood samples, carry out physical function test, and measure health status and context of physical behaviors using questionnaires. The ActivPal™ device was used to assess physical behaviors and the participants were asked to attend two sessions at (LHRC). The feasibility of the current study was assessed by evaluating recruitment capability, acceptability, suitability of study procedures, and resources and abilities to manage and implement the study. Exit interviews were conducted with all participants.

A total of 75 participants expressed an interest in the study, out of whom 54 initially agreed to participate. Ultimately, 48 participants were recruited in the study (recruitment rate: 64%). The study completion rate was 87.5% of the recruited participants; 95% participants were satisfied with their participation in the study and 90% reported no negative feelings related to participating in the study. One participant reported experiencing moderate skin irritation related to placement of the accelerometer. Additionally, 96% of participants expressed their willingness to participate in the study again.

Based on successful methodology, data collection results, and participants’ acceptability, the ProPASS protocols are feasible to administer in Saudi Arabia. These findings are promising for establishing a prospective cohort in Saudi Arabia.

Peer Review reports

Global data from 2023 indicate that an estimated 27.5% of adults do not meet physical activity guidelines and have poor physical behaviors (e.g., physical activity, sedentary behavior, and sleep) that are linked with an increased risk of morbidity and mortality [ 1 , 2 , 3 , 4 ]. Sufficient physical activity and sensible sedentary times are associated with better health outcomes (e.g., cardiovascular health, mental health, and physical function) [ 1 , 2 ]. Despite this fact, 50–90% of Saudi Arabian adults perform low or insufficient daily physical activity; about 50% spend at least five hours per day sitting [ 5 ]. Furthermore, around 33% of the population experiences sleep durations of less than 7 h per night [ 6 ]. These trends could be a reason why non-communicable diseases account for 73% of mortality and cardiovascular diseases account for 37% of all deaths among Saudi Arabian adults [ 7 ]. However, there have been few studies in Middle Eastern countries, and the evidence that links between physical behaviors and health outcomes is under-represented in Saudi Arabia [ 1 ].

Furthermore, within Saudi Arabia, the few studies exploring this connection often rely on self-reported physical behaviors that often do not provide the most accurate picture [ 5 , 8 , 9 , 10 , 11 ]. This lack of data necessitates studies that incorporate measurements from devices that directly track these behaviors among Saudi Arabian adults, which aligns with recent guidance from the World Health Organization (WHO) on the necessity of incorporating device-measured physical behaviors into future studies to explore their relationships with various health aspects [ 1 , 12 ]. By employing such a method, we can gain more precise insights into the dose-response relationships between different physical behaviors and various health outcomes among Saudi Arabian adults.

The Prospective Physical Activity, Sitting, and Sleep Consortium (ProPASS) is an initiative that aims to explore how thigh-based accelerometry measurement of physical behaviors influences a wide range of health outcomes. This initiative operates on a global scale and aims to harmonize data from both retrospective and future studies [ 13 ]. To fulfill the aim, ProPASS is developing methods for collecting prospective data and processing, harmonizing, and pooling data from previous and future studies [ 14 ]. To date, the methods of the ProPASS consortium have been used to harmonize data from large-scale epidemiological studies, such as the 1970 British Birth Cohort, the Australian Longitudinal Study on Women’s Health [ 15 ], and Norway’s Trøndelag Health Study (HUNT) [ 16 , 17 ]. As such, this study seeks to determine if the ProPASS methodologies will be effective in the context of data collection within Saudi Arabia. This will be beneficial because it will help to standardize the measurement of physical behaviors, enhance harmonization across studies, and create more a representative and valid understanding of the associations between physical behaviors and health globally, including under-represented countries such as Saudi Arabia.

This paper describes the feasibility of baseline ProPASS data collection in Saudi Arabia with prospectively harmonized data with the main resource. This feasibility study of baseline data collection will serve as a framework for a future cohort study that will investigate the associations between device-measured physical behavior (e.g., physical activity, sedentary behavior, and sleep) and cardiometabolic health in Saudi adults.

The study was approved by the Institutional Review Board at Princess Nourah Bint Abdul Rahman University, Riyadh, Saudi Arabia (IRB 22–0146), and was carried out in accordance with the principles of the Declaration of Helsinki.

Study design and procedures

Participants were informed about the study’s aims and asked to read and sign the consent form before any measurements were taken. After agreeing to participate, they were asked to attend two sessions at the Lifestyle and Health Research Center (LHRC) at the Health Sciences Research Center of Princess Nourah Bint Abdulrahman University. During the first visit, each participant’s anthropometric measurements (e.g., height, weight, waist circumference), blood pressure and heart rate, blood samples, and handgrip strength were measured. Next, the participants completed questionnaires on demographic information, dietary habits, self-rated health, self-reported smoking status, and the Global Physical Activity, Sedentary Behaviors, and Sleep behavior questionnaires. At the end of the first visit, the researcher attached the ActivPAL™ accelerometer device to their thigh which they were asked to wear for seven consecutive days. Participants were also provided with a diary to record their waking and sleeping hours [ 18 ]. On the 8th day of study, the participants were asked to attend the LHRC for session two where they returned the device and were interviewed (see Fig.  1 ).

Demonstration and summary of the study procedure

Participants and eligibility

The study aimed to recruit a total of 50 Saudi adults aged ≥ 30 years, which is generally considered a common sample size for feasibility studies [ 19 , 20 ]. The eligibility criteria were: (1) Saudi nationals (2), resident in Riyadh, and (3) aged ≥ 30 years old. The exclusion criteria were: (1) having a current medical condition that forces them to be chair-bound or bedridden for more than half of their waking hours (2), being allergic to plasters or adhesives (3), being allergic to low-density polyethylene (4), having a skin condition that would prevent them from wearing the monitor, and (5) those who may need to pass through a metal detector/security checkpoint during the duration of the study. The study’s aims, protocol, and procedures were clearly described to all participants before any measurements were taken.

Recruitment

Participant recruitment was carried out over the month of November 2022. Participants were recruited from different locations across Riyadh, Saudi Arabia, by using electronic flyers on social media (e.g., Twitter, WhatsApp) that provided information about the study and the researcher’s contact details. Prospective participants who were interested in joining the study were asked to provide their contact information via a link to Google Forms featured in the study description. The participants who initially expressed interest but later decided not to join were invited to share their reasons for non-participation through a physical or telephonic meeting.

Measurements based on ProPASS methodology

The current study employed the ProPASS method and protocol for new cohort studies that seek to join ProPASS prospectively [ 14 , 21 ]. All measurements were taken by researchers that were well-trained in the ProPASS protocol and methods. Blood pressure and hand grip strength measurements were taken three times, and the mean average was then calculated; all other measurements were taken only once.

Anthropometric measurements

Height (to the nearest 0.1 cm) and weight (to the nearest 0.1 kg) were measured with a stadiometer (SECA 284; Seca, Hamburg, Germany), and scale (SECA 284; Seca, Hamburg, Germany), respectively. Waist circumference (to the nearest 0.1 cm) was measured midway between the lower rib margin and the iliac crest at the end of a gentle expiration [ 22 ]. Body mass index (BMI) was calculated using the standard calculation (height in meters squared/body weight in kilograms).

Blood pressure and heart rate

Blood pressure was taken after resting for five minutes in a sitting position. Blood pressure was taken three times with one minute between measurements and the average reading was recorded [ 23 ]. Blood pressure and heart rate were measured using a Welch Allyn Connex 7300 Spot Vital Signs Monitor, which provides a high degree of accuracy [ 24 ]. Mean arterial pressure (MAP) was then calculated (MAP = 1/3 * SBP + 2/3 * DBP in mm Hg) using the average of both the SBP and DBP values [ 25 ].

Blood samples

Non-fasting finger-prick (capillary) blood samples (40 µL) were collected for analysis after warming the finger for five minutes. A drop of blood was taken directly from the heated finger to be analysed for blood glucose, triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. A previously validated CardioChek PA analyser (CardioChek PA Blood Analyser, UK) was used to analyse the blood samples [ 26 , 27 ].

Medication use

Participants’ medication use was evaluated by the question: Do you currently use any prescription medicines ? If the answer was yes, the participants were asked which medications they use, such as medication for high blood pressure, high cholesterol, asthma, COPD, anxiety, depression, thyroid problems, allergies. They were also asked whether the medication was in the form of tablets, or nasal sprays, whether the medication was anti-inflammatory, chemotherapeutic, urological, birth control, or neurological, and the age at which the participants had begun using the medication.

Familial disease history

Familial disease history was assessed by the question: Do your parents, siblings or children have, or have they ever had, some of the following diseases before the age of 60 ? The responses included asthma, hay fever/nasal allergies, chronic bronchitis, emphysema or COPD, anxiety or depression, myocardial infarction (heart attack), diabetes, stroke or brain hemorrhage, and cancer. The responses were yes, no , and I don’t know .

Chronic health status

Participants’ chronic disease status and/or long-term health issues were assessed by the question: Have you had, or do you have any of the following diseases? The responses included angina, myocardial infarction (heart attack), heart failure, peripheral vascular disease, atrial fibrillation, stroke/brain hemorrhage, thrombosis, pulmonary embolism, asthma, COPD or emphysema, diabetes, hypothyroidism (low metabolism), hyperthyroidism (high metabolism), cancer, migraine, psoriasis, kidney disease, arthritis (rheumatoid arthritis), Bechterew’s disease, gout, mental health problems, osteoporosis, sleep apnea, arthrosis, nerve disease, hearing/ear disease, eye disease, and infection. Those who replied yes were asked a follow-up question: How old were you when you had it for the first time?

Mobility limitations

The questionnaire was based on three questions on performance-based measures of mobility, which had already been translated and culturally adapted into Arabic [ 28 ]. These three questions are valid and reliable tools to identify the early indications of disability and can be used as indicators to identify those at high risk of future disability [ 29 ]. Self-reported mobility was assessed via the following questions: (1)  Do you have difficulty in walking 2.0 km?  (2)  Do you have difficulty in walking 0.5 km ? and (3)  Do you have difficulty in walking up one flight of stairs? The five response options were: (1)  able to manage without difficulty  (2), able to manage with some difficulty  (3), able to manage with a great deal of difficulty  (4), able to manage only with the help of another person, and  (5)  unable to manage even with help.

Dietary habits

The dietary habits questionnaire was translated and culturally adapted into Arabic [ 28 ]. The questionnaire assessed the dietary habits of the participants was adapted from the Survey of Health, Aging, and Retirement in Europe (SHARE), which has been demonstrated to be a valid and reliable tool for assessing diet [ 30 ]. The questionnaire focused on the consumption of dairy products, legumes, eggs, meat, fruit and vegetables.

Self-rated health

A set of valid and reliable questions adapted from Idler et al.’s (1997) questionnaire was used to assess participants’ self-rated health by asking them to rate their health status using the following questions: (1)  In general, would you say your health is…: Excellent; Very good; Good; Fair; Poor;  (2)  Compared to one year ago, how would you rate your health in general now?: Much better now than one year ago; Somewhat better now than one year ago; About the same; Somewhat worse now than one year ago; Much worse now than one year ago [ 31 , 32 ].

Smoking habits

Self-report questions on smoking behavior were adapted from the UK Biobank questionnaire and were used to assess participants’ present and past smoking habits including at what age they began smoking. the number of cigarettes smoked per day, the type of tobacco used, the duration of smoking, and, among former smokers, the age when smoking ceased [ 33 ].

Physical behaviours

Physical behaviors such as physical activity, sedentary behavior, and sleep were measured by using (1) self-reported and (2) device-based measures:

Self-report measures

Physical activity was measured on a self-report basis via the Global Physical Activity Questionnaire (GPAQ) which was translated into Arabic and previously validated [ 34 ]. In addition, the Sedentary Behavior Questionnaire (SBQ), which had already been translated into Arabic [ 28 ], was used to subjectively assess participants’ sedentary behavior time [ 35 ]. Lastly, the Pittsburgh Sleep Quality Index was used to assess sleep quality and sleep disturbances over a one-month period [ 36 ].

Device-based measures

Physical behaviors were measured by wearing a thigh-worn accelerometer device (an ActivPAL™ Micro4, PAL technologies, Glasgow, Scotland) that participants wore continuously for 24 h for seven full days [ 37 ]. The Activpal™ device was sealed with a nitrile sleeve and attached with a medical waterproof 3 M Tegaderm transparent dressing on the front of the right mid-thigh on the muscle belly by a well-trained member of researcher team. The ActivPAL™ monitor is a valid and reliable measure of time spent walking [ 38 ], sitting, and standing time in healthy adults [ 39 ]. In addition, the participants were asked to fill in a recording sheet that included a sleep diary (times that the participant went to and got out of bed), as well as, the dates and times when the accelerometer fell off or was removed.

Physical function

Physical function was objectively measured using a digital hand-grip strength dynamometer (Takei Hand Grip Dynamometer 5401-C, Japan) via three successive hand-grip assessments for each hand (left and right); the mean value for each hand was then recorded. The instrument can measure hand-grip values from 5 to 100 kg; the minimum unit of measurement is 0.1 kg. The tool is a good health outcomes predictor [ 40 , 41 ].

Data collection evaluation of feasibility

Overall, the study evaluated feasibility in two main stages where feedback from the first six participants was used to resolve any unforeseen issues in the protocol implementation on the remaining participants. Any changes to the procedure were documented.

The current study evaluated the feasibility of Saudi adults’ participation based on the following constructs: (1) recruitment capability (2), acceptability and suitability of study procedures, and (3) resources and ability to manage and implement the study. Table  1 outlines the feasibility constructs, measures, outcome definitions, and methods employed. In evaluating feasibility, the current study followed the recommendations for a feasibility study as reported by Orsmond and Cohn, 2015 [ 42 ].

Overall, the study collected data on the feasibility constructs via tracking the registration, equipment availability, and time spent on various tasks performed (for example training researchers, performing various tasks like attaching the sensor) and completion rate (such as tracking diary entries, questionnaire entries and number of days with accelerometer data), via personal contacts (for information on barriers and facilitators of participation), via processing sensor data, and via interviews after the measurement (for example obtaining information on potential issues during measurement and willingness to participate).

Participant interviews after measurement

After the completion of the study, face-to-face semi-structured interviews were conducted with all participants who had completed the 7-day study period. The aim of these interviews was to collect comprehensive feedback regarding participants’ experiences with the study protocol, with the goal of capturing additional insights that was not captured by other feasibility measures. Some examples of such measures were motivations for joining the study, their expectations prior to participation, and their levels of satisfaction with the study procedures. A detailed interview guide is described in Appendix A [ 28 , 43 , 44 ].

Statistical analysis

Descriptive analysis summarized participants’ demographics, anthropometric measurements, health status, clinical measurements, physical behaviors characteristics, and interview questions responses. The continuous variables were characterized using mean ± standard deviations (SD), while categorical variables were presented using frequencies accompanied by percentages (%). The recruitment rate was calculated by the number of participants who participated and signed the consent form / total number of participants who registered in the study (see Fig.  2 ). Additional analyses were performed to compare participants who reported burden with those who reported no burden of participation (see supplementary materials). T-tests and Chi-square tests were employed for this comparison. IBM’s Statistical Package for the Social Sciences (SPSS) (version 27 SPSS, Inc. Chicago, Illinois) was used to conduct the qualitative analysis. The raw data of ActivPAL were analyzed by using the ActiPASS software (ActiPASS © 2021 - Uppsala University, Sweden).

Recruitment and study participant’s diagram

A total of 75 participants initially volunteered to participate. Ten participants were excluded from the study as they did not meet the inclusion criteria ( n  = 8) or could not be contacted ( n  = 2). In addition, 11 participants withdrew their interest in participating for various reasons: (1) excessive distance between the location of the study (LRHC) and their residence ( n  = 3) (2), hesitant about joining the study ( n  = 1) (3), believed that the ActivPAL™ device would interfere with his/her health ( n  = 1) (4), believed that the ActivPAL™ device would interfere with their regular exercise routine ( n  = 2) (5), had family and work commitments ( n  = 3), and (6) claimed that the timing was unsuitable ( n  = 1). Out of a total of 54 participants who had agreed to participate in the study, 48 participants from Riyadh, Saudi Arabia, attended and completed the consent form. However, four of those participants provided incomplete data (i.e., they completed the questionnaires only and did not wear an ActivPAL™ device). Therefore, a total of 44 participants out of 75 potential participants (59%) successfully completed the study (wore an ActivPAL™ device and completed all questionnaires). See Fig.  2 for the study’s recruitment flow.

Participants

Of the 48 participants, nearly half were female (47.9%). On average, the participants were 37 ± 7.3 years old, had a BMI of 28.3 ± 5.6, and a waist circumference of 86.9 ± 16.4 cm. Most participants were married, had college degrees, were employed as office workers and professionals, had never smoked, and did not use any medication (see Table  2 ). A total of 87.5% of participants had a family history of disease; 85.4%, 95.8%, and 89.6%, reported having no difficulty walking 2 km, 500 m, and up one flight of stairs, respectively. Approximately 48% of participants rated their health as very good , while 39.6% reported their health as about the same compared to one year ago . In terms of dietary habits, nearly half the participants reported consuming dairy products every day, 25% consumed legumes and eggs 3 to 6 times a week, 56.3% consumed meat every day, and 45.8% consumed fruits and vegeTables 3, 4, 5 and 6 times a week.

Table  3 presents the primary variables of the study: including average systolic, diastolic, and mean arterial pressure values of 121.13 ± 11.81 mmHg, 79.26 ± 8.92 mmHg, and 93.15 ± 9.20 mmHg, respectively. The mean resting heart rate was 74.3 ± 12.66. Furthermore, the non-fasting blood profile of the sample was analyzed and showed the following values: total cholesterol: 177.89 ± 33.79 mg/dL; HDL-cholesterol: 50.96 ± 13.02 mg/dL; triglycerides: 123.94 ± 68.92 mg/dL; LDL-cholesterol: 103 ± 29.89 mg/dL; TC/HDL-cholesterol ratio: 3.71 ± 1.11; LDL/HDL-cholesterol ratio: 2.19 ± 0.81; non-HDL-cholesterol: 127.06 ± 33.51 mg/dL; non-fasting glucose: 102.98 ± 35.36 mg/dL. Table  3 provides an overview of the participants’ physical activity related behaviors.

Feasibility evaluation

The following results highlight the approaches taken by the current study to assess the feasibility of baseline data collection using ProPASS methodology specifically in the context of Saudi Arabia.

The evaluation of the feasibility of the study protocol was conducted in two stages, initially involving six participants, whose feedback was used to refine and improve the protocol implementation for the remaining participants. Of the six selected participants, three were female. In the pre-evaluation, only two minor issues were encountered; (1) accessing the lab outside of working hours (16:00–22:00) as most participants were unable to attend during the day (07:00–16:00) due to work commitments. This issue was resolved in all subsequent data collection points by receiving approval for extended lab hours; (2) obtaining the required number of ActivPAL™ devices from the technical coordinator due to miscommunication and high demand by other researchers. To prevent further issues, the author obtained 30 devices in advance for the feasibility evaluation.

Recruitment capability

The recruitment rate was used to measure the feasibility of recruitment methodology to collect baseline ProPASS data; the results showed that 64% ( n  = 48) of participants signed the consent form and attended the LRHC lab (see Fig.  2 ). After screening the eligibility criteria, out of a total of 75 participants, 65 met the study criteria, and 11 were excluded from participating due to the reasons as detailed in Fig.  2 . As Fig.  2 illustrates, although 54 participants scheduled an appointment for the study, only 48 (64%) attended and signed the consent form. In the final stage of the recruitment process, around 59% ( n  = 44) of participants completed all the required measurements for the study.

Acceptability and suitability of study procedures

The adherence rate (i.e., the extent to which participants adhered to the outlined procedures in terms of the number of days with valid accelerometry data) was 5.7 days. Furthermore, participants provided sleep diary entries for 85.4% of days. All questionnaires were completed with a 100% response rate.

To assess the study’s time demands on participants, the length of time participants needed to complete all measurements was mean time of 25 min (23 min to complete the questionnaires and two minutes to attach the sensor). Additionally, the completion rates for the registered participants who completed all the required measurements (i.e., accelerometer measurement, diary registration, and questionnaires) was 91.6%. (See Table  4 ).

Resources and ability

The final feasibility outcomes (i.e., having the required resources and ability to manage and implement the study) are presented in Table  5 . This objective was assessed based on four domains: skin irritation, equipment availability, training requirements, and accelerometer loss (see Table  5 ). The first domain revealed that three participants experienced skin irritation during the study; of these, two participants had mild symptoms, such as itchiness and discomfort that lasted for the first three days but did not lead to their withdrawal from the study. However, one participant reported moderate irritation resulting in red skin which required them to withdraw from the study. The second domain, equipment availability, indicated that all the necessary equipment was available 100% of the time. The third domain was training requirements, and the researchers required four hours of training on how to use it correctly. Finally, in the accelerometer loss domain, the study recorded four failed devices out of 30 that did not generate data for seven days.

Participant interview after measurement

After completing the study, all participants were interviewed around five primary themes: (1)  motivation and expectations of participation  (2), participant satisfaction  (3), the burden of participation  (4), willingness to participate again , and (5)  perception of time usage (see Fig.  3 ).

Interview outcomes of participant’s experience with the study protocol

To determine the participants’ motivations for and expectations about joining the study, they were asked: What made you want to join this study? The results showed that 90% of participants were interested in learning about their physical behaviors and health status; 43% participated in supporting the researcher, and 14% reported that the final report attracted them to participate (see Fig.  3 a and the example of final report in supplementary material). Participant satisfaction was assessed via two questions: (1)  What was your overall experience of participating in the study? and (2)  Was it as you expected? The findings indicated that 62% of participants were satisfied that the study was as expected, 33% were more satisfied than expected, and 5% were unsatisfied and found the study below their expectations (see Fig.  3 b).

Regarding the overall burden of participation, 76% of participants reported that it was no burden , 5% reported that it was a burden , and 14% believed it was somewhat burdensome (see Fig.  3 c). Additionally, 79% of participants expressed their willingness to participate again in the future (see Fig.  3 d). Finally, regarding time usage, 67% of participants found it easy to complete the seven-day study without any concerns (see Fig.  3 h).

The feasibility of the baseline ProPASS data collection methodology was evaluated among Saudi adults who participated in this study. The findings revealed that the methodology was both feasible and acceptable, paving the way for large-scale prospective cohort research in Saudi Arabia. This research marks the first attempt to establish a prospective cohort study in Saudi Arabia using established ProPASS methods [ 13 , 15 ] and protocols. Conducting such a cohort study in Saudi Arabia is crucial due to the country’s high prevalence of non-communicable diseases that are mostly due to poor physical behaviors (e.g., lack of physical activity, sedentary behavior, and sleep) [ 7 ], due to recent enormous economic growth accompanied by technological transformations and urbanization [ 11 ].

The first aspect of feasibility evaluated of the baseline ProPASS data collection methodology was the capability to recruit participants. The findings indicated that the recruitment rate was 64% which is similar to prior studies [ 46 , 47 ]. One study indicated that a recruitment rate of at least between 20 and 40% is required to be deemed feasible [ 48 ]. Thus, the recruitment rate in the current study seems acceptable for creating a future cohort using ProPASS methods in Saudi Arabia. Additionally, in the current study, the refusal rate was only 15% which is significantly lower than in previous studies [ 45 , 49 ] where refusal rates ranged from 50 to 66%. One reason for the low refusal rate in the current study is that the recruitment was material specifically designed to motivate Saudi participants to join the study by indicating that the study would provide data and insight into their current state of health. For example, the results of the semi-structured interviews illustrated that 90% of participants joined the study because they wanted to know about their physical behaviors and health status (see Fig.  3 ). This result also indicates that our recruitment material might be suitable for ensuring high participation in the future cohort study.

The second aspect of feasibility for the baseline ProPASS data collection methodology that was evaluated in this study was the acceptability and suitability of the study procedures. Previous studies have shown that in order to obtain reliable estimates of adults’ habitual physical activity, it is necessary to record accelerometer data for 3–5 days [ 50 , 51 ] to gather valid data to perform analysis and provide information about the habitual physical behaviors. A recent study indicated that distributing accelerometers in person was associated with a high proposition of participants consenting to wear an accelerometer and meeting minimum wear criteria [ 21 ]. Our study was able to collect an average six days of valid data which was sufficient to obtain representative descriptions of the participants’ physical behaviors [ 52 ]. There were high general adherence rates for participant diary entries, questionnaires completion, and adherence to the study protocol, indicating that the ProPASS methods could be feasibly implemented with a larger study population. The study also assessed the time commitment necessary to complete the questionnaires and attach the ActivPAL™ devices to participants’ thighs. Completing the questionnaires took approximately 23 min (SD = 8). Prior studies have indicated that shorter questionnaires (e.g., 20 min) yield a higher response rate from participants, a finding that was consistent with our study [ 53 , 54 ]. Additionally, attaching the sensor to the participant’s thigh took about two minutes. These findings indicate that participation in this study was not burdensome, which was confirmed by the interviews that showed that 95% of participants felt that participating in the study (i.e., filling out all questionnaires and wearing the ActivPal™ device for 7 days) was not a burden. Overall, ProPASS methods appear to be less burdensome, well-suited, and readily accepted by participants.

The third aspect of feasibility for the baseline ProPASS data collection methodology was the availability of resources and the ability to manage and execute the study. As we aim to create a new cohort adhering to global (ProPASS) standards, protocol training was vital to obtain quality outcomes as per the ProPASS protocol. As a result, the protocol training took around four hours which was similar to a prior study [ 45 ]. In terms of the availability of resources, all essential equipment was always accessible. The study also considered skin irritation as an important factor. One study noted that 38% of participants stopped using ActivPal™ due to skin irritation from PALstickies or Tegaderm dressings [ 55 ]; another reported one discontinuation due to irritation associated with a Tegaderm dressing [ 56 ]. In the current study, there were three reported irritations, with two having mild initial discomfort that eventually subsided. One participant left the study due to moderate irritation. Nonetheless, it is important to note that the data collection occurred during colder winter periods (average 20 degrees Celsius). It is possible that instances of skin irritation could be more pronounced during Saudi Arabia’s hot summer season, characterized by temperatures of approximately 40 degrees Celsius. Future studies should investigate the feasibility of using devices and tape suitable for summer temperatures. In addition, the current study also had a low accelerometer failure rate: only four accelerometers failed to record, which is similar to previous studies [ 57 , 58 ]. All ActivPal™ devices were returned at the end of the study during visit two, ensuring that the ProPASS method is suitable to be used in future cohorts in Saudi Arabia.

Strengths and limitations of Study

This study represents the first of its kind to utilize device-based measures for assessing physical behaviors among adults in Saudi Arabia. The device-based measure has been shown to provide useful information about physical behaviors when compared to using self-report questionnaires [ 16 ]. Furthermore, it marks the initial examination of the ProPASS consortium method in the Middle East, particularly in Saudi Arabia. Nevertheless, the current study has certain limitations including recruiting among relatively young participants, presumably without any medical conditions and with postgraduate qualifications. This may limit the generalization of the findings to the entire population. The acceptability of the study in other age groups and among individuals with lower educational backgrounds is yet to be studied. In addition, the feasibility of the baseline ProPASS data collection methodology study was conducted during winter, which might have influenced the observed levels of physical behaviors in our sample. Similarly, the study was unable to evaluate the feasibility of utilizing 3 M Tegaderm dressings in hot summer months. Lastly, it’s important to note that our study employed a relatively small sample size; nonetheless, this size is considered acceptable for feasibility studies.

The baseline ProPASS data collection methodology and protocol for a future cohort study are both feasible and acceptable for implementation within the context of Saudi Arabia. This feasibility study represents the first step toward establishing a prospective ProPASS cohort study to examine the association between physical behaviors and cardiometabolic health among Saudi Arabian adults.

Availability of data and materials

The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request.

Abbreviations

The Prospective Physical Activity, Sitting and Sleep consortium

Physical activity, sedentary behavior, and sleep

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Acknowledgements

The authors would like to express gratitude to all participants for their involvement in the study. Additionally, we extend our appreciation to the research assistants (Rasil Alhadi, Ragad Alasiri, and Khalid Aldosari) who assisted in the data collection. Finally, we would like to thank the LHRC, Princess Nourah Bint Abdulrahman University for providing their site for collecting the data.

This research was supported by the Deanship of Scientific Research, Vice Presidency for Graduate Studies and Scientific Research, King Faisal University, Saudi Arabia [Project No. GrantA353]. The funders had no role in study design, data collection and analysis, the decision to publish, or the preparation of the manuscript.

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Abdulrahman I. Alaqil

Center for Active and Healthy Ageing (CAHA), Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, 5230, Denmark

Abdulrahman I. Alaqil, Borja del Pozo Cruz & Paolo Caserotti

Department of Musculoskeletal Disorders and Physical Workload, National Research Centre for the Working Environment, Lersø Parkalle 105, Copenhagen, 2100, Denmark

Abdulrahman I. Alaqil, Andreas Holtermann & Nidhi Gupta

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Borja del Pozo Cruz

Biomedical Research and Innovation Institute of Cádiz (INiBICA) Research Unit, University of Cádiz, Cadiz, Spain

Lifestyle and Health Research Center, Health Sciences Research Center, Princess Nourah Bint Abdulrahman University, Riyadh, 11671, Saudi Arabia

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Mackenzie Wearables Research Hub, Charles Perkins Centre, The University of Sydney, Camperdown, NSW, Australia

Matthew N. Ahmadi & Emmanuel Stamatakis

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Conceptualization: AIA, NG, ES, and BdCMethodology: AIA, NG, ES, HMA, and BdCInvestigation: AIAData collection: AIAInterpretation of the findings: AIA, HMA, ES, NG, AH, PC, MNA, and BdCDrafting the paper: AIAReviewing and editing the draft: AIA, ES, HMA, BdC, SAA, PC, MNA, AH, and NGAll authors critically read, revised the draft for important intellectual content, approved the final version of the manuscript to be published, and agreed to be accountable for all aspects of the work.

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Correspondence to Abdulrahman I. Alaqil .

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The Ethic approval was obtained from the Institutional Review Board at Princess Nourah Bint Abdul Rahman University, Riyadh, Saudi Arabia (IRB 22–0146). Written informed consent was obtained from participants. All methods were carried out in accordance with the Declaration of Helsinki.

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Alaqil, A.I., del Pozo Cruz, B., Alothman, S.A. et al. Feasibility and acceptability of a cohort study baseline data collection of device-measured physical behaviors and cardiometabolic health in Saudi Arabia: expanding the Prospective Physical Activity, Sitting and Sleep consortium (ProPASS) in the Middle East. BMC Public Health 24 , 1379 (2024). https://doi.org/10.1186/s12889-024-18867-2

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Received : 12 September 2023

Accepted : 16 May 2024

Published : 22 May 2024

DOI : https://doi.org/10.1186/s12889-024-18867-2

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