Physical Activity Smartphone App for African American Men (FitBros) Phase I

NCT ID: NCT05509712

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2022-07-31

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.

Conditions

Exercise; Health Behavior; Technology

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: OTHER

Study Groups

Focus Groups to Refine MobileMen App Content

Focus groups are conducted virtually to refine content in the mobile app for African American men. African American men are recruited in Louisiana and Washington, DC and surrounding areas, using via listservs, ResearchMatch, social media, community events, local networking, and word of mouth.

Focus Groups to Refine MobileMen App Content

Intervention Type: BEHAVIORAL

Participants are shown a clickable wireframe of the proposed new app features, including competition, animated badges, leaderboard, and incentives. Focus group members discuss perceptions, ease of use, and interest in the app design/features and identified additional or unnecessary features for adopting and maintaining physical activity (PA).

Beta testing of MobileMen App Prototype

The prototype MobileMen app is evaluated for feasibility, acceptability, and usability in semi-structured interviews with African American men recruited in Louisiana who meet eligibility criteria similar to those used for the focus groups

Beta testing of MobileMen App Prototype

Intervention Type: BEHAVIORAL

Project staff present the clickable wireframe prototype and have men navigate and test features using a structured script. Staff track participant responses in notes, as well as through both recording via a side profile and the device screen. At the conclusion of the session, participants complete surveys measuring satisfaction, helpfulness, and usability.

Interventions

Focus Groups to Refine MobileMen App Content

Participants are shown a clickable wireframe of the proposed new app features, including competition, animated badges, leaderboard, and incentives. Focus group members discuss perceptions, ease of use, and interest in the app design/features and identified additional or unnecessary features for adopting and maintaining physical activity (PA).

Intervention Type: BEHAVIORAL

Beta testing of MobileMen App Prototype

Project staff present the clickable wireframe prototype and have men navigate and test features using a structured script. Staff track participant responses in notes, as well as through both recording via a side profile and the device screen. At the conclusion of the session, participants complete surveys measuring satisfaction, helpfulness, and usability.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• self-identified African American male
• at least 30 years of age

Exclusion Criteria

• cognitive impairment that would interfere with participating in a group discussion
• unwilling to be audio and video-recorded
• unwilling to give written informed consent

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

Sponsors

Georgetown University

OTHER

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

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

Other Identifiers

1R42MD0014947-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0334

Identifier Type: -

Identifier Source: org_study_id