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

NCT05621044 | Completed

• 2 other identifiers: 03404R42MD014947-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Exercise; Health Behavior; Technology

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 9 months

Secondary Outcomes (7)

• Change from Baseline in Weight at 9 Months

  Baseline and 9 months

• Change from Baseline in Blood Pressure at 9 months

  Baseline and 9 months

• Change from Baseline in Quality of Life Assessment at 9 Months

  Baseline and 9 months

• Change from Baseline in Dietary Habits at 9 Months

  Baseline and 9 months

• Satisfaction Assessment

  9 months

Study Arms (2)

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.

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.

Behavioral: Nike Training Club

Interventions

Nike Training Club 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.

Comparator app

FitBrothers smartphone active app 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.

FitBrothers smartphone active app

Eligibility Criteria

• Age: 30 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• unwilling to give written informed consent
• conditions that prevent regular exercise

Sponsors & Collaborators

• Klein Buendel, Inc.: lead
• Pennington Biomedical Research Center: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Georgetown University: collaborator

Study Sites (3)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• 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.

  PMID: 40613599 DERIVED

MeSH Terms

Conditions

Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Robert Newton, PHD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Behavioral

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 17, 2022
• Study Start: May 1, 2024
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

US (3)