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Clinical Trials/NCT05509712
NCT05509712
Completed
Not Applicable

Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) Phase I

Klein Buendel, Inc.3 sites in 1 country38 target enrollmentMarch 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exercise
Sponsor
Klein Buendel, Inc.
Enrollment
38
Locations
3
Primary Endpoint
Usability
Status
Completed
Last Updated
2 years ago

Overview

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 will be developed first through this Phase I consisting of (1) iterative focus groups, (2) developing a conceptual model, and (3) conducting beta testing. 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 proposal 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.

Registry
clinicaltrials.gov
Start Date
March 7, 2022
End Date
July 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Usability

Time Frame: Baseline

Usability is assessed by the 10-item System Usability Scale (SUS).

Formative Research

Time Frame: Baseline

Notes from focus group members include perceptions, ease of use, and interest in the app design/features and identified additional or unnecessary features for adopting and maintaining physical activity (PA). Notes are consolidated and utilized for qualitative analysis via a thematic analytic approach.

Formative Evaluation

Time Frame: Baseline

Notes from participants responses and recordings of their movements on the device screen provide feedback on the prototype. Satisfaction and helpfulness of app components is measured by a 14-question posttest survey.

Study Sites (3)

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