Physical Activity Smartphone App for African American Men (FitBros) Ph II

NCT ID: NCT05621044

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-03-15

Brief 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 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.

Conditions

Exercise; Health Behavior; Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

FitBrothers smartphone active app

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.

Group Type: EXPERIMENTAL

FitBrothers smartphone active app

Intervention Type: BEHAVIORAL

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.

Comparator app

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.

Group Type: ACTIVE_COMPARATOR

Nike Training Club

Intervention Type: BEHAVIORAL

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.

Interventions

FitBrothers smartphone active app

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.

Intervention Type: BEHAVIORAL

Nike Training Club

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

Exclusion Criteria

• unwilling to give written informed consent
• conditions that prevent regular exercise
• conditions that the medical or principal investigator determine to warrant exclusion

• Minimum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: collaborator

Klein Buendel, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Newton, PHD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Klein Buendel, Inc.

Golden, Colorado, United States

Georgetown University

Washington D.C., District of Columbia, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40613599 (View on PubMed)

Other Identifiers

4R42MD014947-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0340

Identifier Type: -

Identifier Source: org_study_id