ExerciseNCT05621044
Physical Activity Smartphone App for African American Men (FitBros) Ph II
A study testing FitBrothers smartphone active app and Nike Training Club in people with Exercise and Health Behavior, run by Klein Buendel, Inc. at 3 sites in United States.
Trial summary
Low physical activity levels contribute to African American men experiencing health disparities across a number of chronic diseases. Studies have been effective in increasing physical activity levels in African American men; but few have targeted maintenance of behavior change and none have utilized emerging… Read more about this study
- Who is it for?
- Ages 30 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise, Health Behavior, Technology
- What is being tested?
- FitBrothers smartphone active app and Nike Training Club
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2024to 22 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Comparative Effectiveness Trial (CET) Inclusion criteria:
- self-identified African American male
- at least 30 years of age
- BMI > 18.5 kg/m2 and < 45 kg/m2
- resting systolic blood pressure # 159 mmHg and a diastolic blood pressure # 99 (to reduce risk of exercise-induced cardiovascular events)
- free of significant medical problems that would impact their ability to engage in aerobic and/or resistance training
- owns a smartphone
- sedentary at baseline (not being physically active ≥3 d·wk-1 for 20 min each time for the previous 6 months, not participating in regular resistance exercise, and having an average daily accelerometer step count less than the 50th percentile for age and gender).
Comparative Effectiveness Trial (CET) Exclusion criteria:
- unwilling to give written informed consent
- conditions that prevent regular exercise
- conditions that the medical or principal investigator determine to warrant exclusion
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Klein Buendel, Inc.
Golden, Colorado, 80401
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) Phase II
Low physical activity levels contribute to African American men experiencing health disparities across a number of chronic diseases. Studies have been effective in increasing physical activity levels in African American men; but few have targeted maintenance of behavior change and none have utilized emerging technologies. The purpose of the current study is to further develop a mobile phone application for African American men that will help them initiate and maintain their physical activity levels.
Read the detailed description
Physical activity (PA) is a modifiable risk factor for a number of preventable chronic diseases, including cardiovascular disease, strokes, obesity, and diabetes. These conditions constitute health disparities for African American men. Behavioral interventions have proven to be effective in promoting increases in physical activity. While behavior change programs have been shown to assist participants in sustaining behavior change, very few programs have specifically targeted African American men. The use of mHealth, as opposed to other avenues of intervention delivery, is based on published reports documenting that African Americans perceive mobile technology as an acceptable means of intervention delivery. In addition, ownership of smartphones and the use of text messaging are highest among African Americans compared to other ethnic groups. Therefore, a mHealth intervention targeting African American men seems feasible and potentially effective. Our preliminary data show that a PA maintenance smartphone app for African American men that contains self-monitoring, goal-setting, reinforcement, and behavioral lessons was well received by this population. However, the qualitative data revealed that the men believed additional components were necessary to fully tailor the app for African American men, including personalization, chronic disease health information, dietary information, competition, and incentives. In addition, the investigators will tailor the intervention to the sociocultural needs of African American men. The purpose of the Fast-Track STTR is to incorporate these elements within an existing smartphone app. The FitBrothers app was developed through a Phase I consisting of (1) iterative focus groups, (2) developing a conceptual model, and (3) conducting beta testing and this Phase II will consist of (1) developing a full-scale FitBrothers app, (2), conducting usability testing, and (3) conducting a comparative effectiveness trial to assess the effectiveness of the app compared to a similar, well-known app in the marketplace. To our knowledge, no study has utilized mobile phones as a means of effecting PA levels in African American men. FitBrothers will address an unmet need in the marketplace as it will be the first smartphone app that is targeted toward PA adoption and maintenance in African American men. The fact that mHealth is acceptable to- and the fact that the application will be developed in collaboration with African American men, leads us to hypothesize that African American men will view the mHealth intervention as acceptable, feasible, and effective. The Fast-Track STTR project will be led by a team that has worked together previously and includes researchers and multimedia developers from Klein Buendel, Inc. (KB), Georgetown University, and Pennington Biomedical Research Center.
- Conditions
- Exercise, Health Behavior, Technology
- Being tested
- FitBrothers smartphone active app, Nike Training Club
- Medical subject headings
- Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitBrothers smartphone active appBehavioural
The FitBrothers smartphone active app is designed to assist African American men with adopting and maintaining PA. The app will be developed with significant input from African American men and contain self-monitoring, goal setting, reward, and educational components. The app will include additional elements including PA adoption strategies, competitions, incentives, health information, and greater compatibility with activity monitoring devices. The intervention is based on the Social Cognitive and Self-Determination theories and is culturally tailored.
Nike Training ClubBehavioural
The app is designed to increase fitness in users through a variety of mechanisms. Users are able to track and monitor their physical activity level, set goals, engage in competitions, and upload activity data from a wearable. They will also be provided with preset workouts, receive guidance from an expert, and receive personalized plans that automatically adapt to user behavior.
| Study group | Role | What they receive |
|---|---|---|
| FitBrothers smartphone active app | Experimental | Participants will be expected to engage with the FitBrothers app on a daily basis. Daily alerts and notifications will engage users in daily use of the app and provide up-to-date information on users' progress. Participant responses will also be used to evaluate additional or on-going support of users' needs (e.g., increase/ decrease prompts based on user preferences, tailored messages around a set goal, etc.). To protect privacy and to ensure that the participant is the person completing the app activities, KB will uniquely identify the user's smartphone based off the device's "hardware footprint". The app will upload all app activity data to the KB secured web server database. Receives: Behavioral: FitBrothers smartphone active app |
| Comparator app | Active comparator | Nike Training Club is a free app available on iOS and Android platforms. The app is designed to increase fitness in users through a variety of mechanisms. Similar to FitBrothers, men will be able to track and monitor their physical activity level, set goals, engage in competitions, and upload activity data from a wearable. They will also be provided with preset workouts, receive guidance from an expert, and receive personalized plans that automatically adapt to user behavior. Unlike the FitBrothers app, the Nike Training Club app was not developed with input from African American men, does not track health information (e.g. blood pressure, blood glucose), does not have a theoretical basis, and does not have specific strategies for maintenance. Receives: Behavioral: Nike Training Club |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Physical activity-Acti Graph at 9 Months
Steps per day will be collected using the ActiGraph WGT3X+BT accelerometer. The device is worn on the wrist for a 7-day period.
Measured: Baseline and 9 months
Secondary outcomes (7)
Change from Baseline in Weight at 9 Months
Weight of each participant will be measured with a scale.
Measured: Baseline and 9 months
Change from Baseline in Blood Pressure at 9 months
Systolic and diastolic blood pressure will be measured at rest, under highly-controlled conditions. All blood pressure measurements will be obtained using a Colin STBP-780 automated blood pressure monitor. The first value will be discarded and the average of the last 3 values will be used, per standard Pennington Biomedical Research Center (PBRC) procedures.
Measured: Baseline and 9 months
Change from Baseline in Quality of Life Assessment at 9 Months
The SF-36 Short Form Health Survey (SF-36) questionnaire will assess quality of life in a number of physiological and mental health domains.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline and 9 months
Change from Baseline in Dietary Habits at 9 Months
The National Cancer Institute's Automated Self-Administered 24-hour Recall will be used to estimate daily intake of selected nutrients and macronutrients, food group servings, and alcohol.
The NCI's Automated Self-Administered 24-hour Recall (ASA24) will be used to estimate daily intake of nutrients and macronutrients, food group servings, and alcohol. This tool enables self-administered 24-hour dietary recalls and calculates Healthy Eating Index scores (minimum score=0, maximum score=100). Healthy Eating Index measures diet quality and assesses conformance to federal dietary guidance. Higher scores reflect better dietary habits.
Measured: Baseline and 9 months
Satisfaction Assessment
A questionnaire will be used to assess each participant's satisfaction with the FitBrothers app.
The questionnaire will assess satisfaction, helpfulness, enjoyment, and relevance across all components of app. Mean scores of 3.5 or greater, rated on a scale of 1 (poor) to 5 (excellent), will be deemed acceptable.
Measured: 9 months
System Usability Scale (SUS)
The System Usability Scale (SUS) is a validated, 10-item measure provides a global view of subjective usability for technology. The 10 questions have 5 response options from "strongly disagree" to "strongly agree". SUS yields a single number representing a composite measure of the overall usability of the system being studied. Note that scores for individual items are not meaningful on their own. To calculate the SUS score the score contributions from each item are summed. Each item's score contribution ranges from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. The sum of these scores are multiplied by 2.5 to obtain the overall value of SU.SUS scores have a range of 0 to 100. SUS scores > 68 are considered acceptable.
Measured: 9 months
FitBrothers App Usage
FitBrothers app usage will be assessed via a number of app usage sessions. Usage will be collected using Webtrends.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 May 2024
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pennington Biomedical Research Center, National Institute on Minority Health and Health Disparities (NIMHD), Georgetown University
- Responsible party
- Sponsor
- Investigators
- Robert Newton, PHD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621044
- Sponsor's protocol ID
- 0340
- Other IDs
- 4R42MD014947-02
- Status last verified
- Feb 2026
- First submitted
- 10 Nov 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nuss K, Brice A, Hebert C, Nauta P, Stull AJ, Swift DL, Griffith DM, Buller DB, Newton RL Jr. A Culturally Tailored mHealth Intervention (MobileMen App) to Promote Physical Activity in African American Men: Protocol for a Comparative Effectiveness Trial. JMIR Res Protoc. 2025 Jul 4;14:e67809. doi: 10.2196/67809.
PubMed 40613599
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) Phase II
- ClinicalTrials.gov ID
- NCT05621044
- Acronym / sponsor ID
- 0340
- Conditions
- Exercise, Health Behavior, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pennington Biomedical Research Center, National Institute on Minority Health and Health Disparities (NIMHD), Georgetown University
- Study start
- 1 May 2024 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low physical activity levels contribute to African American men experiencing health disparities across a number of chronic diseases. Studies have been effective in increasing physical activity levels in African American men; but few have targeted maintenance of behavior change and none have utilized emerging technologies. The purpose of the current study is to further develop a mobile phone application for African American men that will help them initiate and maintain their physical activity levels.
Detailed description
Physical activity (PA) is a modifiable risk factor for a number of preventable chronic diseases, including cardiovascular disease, strokes, obesity, and diabetes. These conditions constitute health disparities for African American men. Behavioral interventions have proven to be effective in promoting increases in physical activity. While behavior change programs have been shown to assist participants in sustaining behavior change, very few programs have specifically targeted African American men. The use of mHealth, as opposed to other avenues of intervention delivery, is based on published reports documenting that African Americans perceive mobile technology as an acceptable means of intervention delivery. In addition, ownership of smartphones and the use of text messaging are highest among African Americans compared to other ethnic groups. Therefore, a mHealth intervention targeting African American men seems feasible and potentially effective. Our preliminary data show that a PA maintenance smartphone app for African American men that contains self-monitoring, goal-setting, reinforcement, and behavioral lessons was well received by this population. However, the qualitative data revealed that the men believed additional components were necessary to fully tailor the app for African American men, including personalization, chronic disease health information, dietary information, competition, and incentives. In addition, the investigators will tailor the intervention to the sociocultural needs of African American men. The purpose of the Fast-Track STTR is to incorporate these elements within an existing smartphone app. The FitBrothers app was developed through a Phase I consisting of (1) iterative focus groups, (2) developing a conceptual model, and (3) conducting beta testing and this Phase II will consist of (1) developing a full-scale FitBrothers app, (2), conducting usability testing, and (3) conducting a comparative effectiveness trial to assess the effectiveness of the app compared to a similar, well-known app in the marketplace. To our knowledge, no study has utilized mobile phones as a means of effecting PA levels in African American men. FitBrothers will address an unmet need in the marketplace as it will be the first smartphone app that is targeted toward PA adoption and maintenance in African American men. The fact that mHealth is acceptable to- and the fact that the application will be developed in collaboration with African American men, leads us to hypothesize that African American men will view the mHealth intervention as acceptable, feasible, and effective. The Fast-Track STTR project will be led by a team that has worked together previously and includes researchers and multimedia developers from Klein Buendel, Inc. (KB), Georgetown University, and Pennington Biomedical Research Center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Behavioral
| Arm | Type | Receives |
|---|---|---|
| FitBrothers smartphone active app | Experimental | Behavioral: FitBrothers smartphone active appParticipants will be expected to engage with the FitBrothers app on a daily basis. Daily alerts and notifications will engage users in daily use of the app and provide up-to-date information on users' progress. Participant responses will also be used to evaluate additional or on-going support of users' needs (e.g., increase/ decrease prompts based on user preferences, tailored messages around a set goal, etc.). To protect privacy and to ensure that the participant is the person completing the app activities, KB will uniquely identify the user's smartphone based off the device's "hardware footprint". The app will upload all app activity data to the KB secured web server database. |
| Comparator app | Active comparator | Behavioral: Nike Training ClubNike Training Club is a free app available on iOS and Android platforms. The app is designed to increase fitness in users through a variety of mechanisms. Similar to FitBrothers, men will be able to track and monitor their physical activity level, set goals, engage in competitions, and upload activity data from a wearable. They will also be provided with preset workouts, receive guidance from an expert, and receive personalized plans that automatically adapt to user behavior. Unlike the FitBrothers app, the Nike Training Club app was not developed with input from African American men, does not track health information (e.g. blood pressure, blood glucose), does not have a theoretical basis, and does not have specific strategies for maintenance. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitBrothers smartphone active appThe FitBrothers smartphone active app is designed to assist African American men with adopting and maintaining PA. The app will be developed with significant input from African American men and contain self-monitoring, goal setting, reward, and educational components. The app will include additional elements including PA adoption strategies, competitions, incentives, health information, and greater compatibility with activity monitoring devices. The intervention is based on the Social Cognitive and Self-Determination theories and is culturally tailored. | Behavioural | FitBrothers smartphone active app |
| Nike Training ClubThe app is designed to increase fitness in users through a variety of mechanisms. Users are able to track and monitor their physical activity level, set goals, engage in competitions, and upload activity data from a wearable. They will also be provided with preset workouts, receive guidance from an expert, and receive personalized plans that automatically adapt to user behavior. | Behavioural | Comparator app |
Primary outcome
Change from Baseline in Physical activity-Acti Graph at 9 Months
Time frame: Baseline and 9 months
Steps per day will be collected using the ActiGraph WGT3X+BT accelerometer. The device is worn on the wrist for a 7-day period.
7 secondary outcomes
Change from Baseline in Weight at 9 Months
Time frame: Baseline and 9 months
Change from Baseline in Blood Pressure at 9 months
Time frame: Baseline and 9 months
Change from Baseline in Quality of Life Assessment at 9 Months
Time frame: Baseline and 9 months
Change from Baseline in Dietary Habits at 9 Months
Time frame: Baseline and 9 months
Satisfaction Assessment
Time frame: 9 months
System Usability Scale (SUS)
Time frame: 9 months
FitBrothers App Usage
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Derived from this study: PubMed 40613599Nuss K, Brice A, Hebert C, Nauta P, Stull AJ, Swift DL, Griffith DM, Buller DB, Newton RL Jr. A Culturally Tailored mHealth Intervention (MobileMen App) to Promote Physical Activity in African American Men: Protocol for a Comparative Effectiveness Trial. JMIR Res Protoc. 2025 Jul 4;14:e67809. doi: 10.2196/67809.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Newton, PHD principal investigator
Pennington Biomedical Research Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitBrothers smartphone active app and Nike Training Club in people with Exercise and Health Behavior, run by Klein Buendel, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Physical activity-Acti Graph at 9 Months (time frame: Baseline and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05621044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.