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

Last updated: November 12, 2024
Sponsor: Klein Buendel, Inc.
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Nike Training Club

FitBrothers smartphone active app

Clinical Study ID

NCT05621044
0340
4R42MD014947-02
  • Ages > 30
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 (toreduce risk of exercise-induced cardiovascular events)

  • free of significant medical problems that would impact their ability to engage inaerobic and/or resistance training

  • owns a smartphone

  • sedentary at baseline (not being physically active ≥3 d·wk-1 for 20 min each timefor the previous 6 months, not participating in regular resistance exercise, andhaving an average daily accelerometer step count less than the 50th percentile forage and gender).

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Nike Training Club
Phase:
Study Start date:
September 11, 2023
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Klein Buendel, Inc.

    Golden, Colorado 80401
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

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