Clinical trial NCT05509712: Physical Activity Smartphone App for African American Men (FitBros) Phase I
Official title: Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) Phase I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise
Health Behavior
Technology
Lead sponsor: Klein Buendel, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Georgetown University
name: Pennington Biomedical Research Center
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-08-22
Enrollment: 38
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African-American Men

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.

Eligibility criteria: Focus groups/usability Inclusion criteria:

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

Focus groups/usability 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

Primary outcomes:
measure: Formative Research
timeFrame: Baseline
measure: Formative Evaluation
timeFrame: Baseline
measure: Usability
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Golden
country: United States
facility: Klein Buendel, Inc
state: Colorado
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Robert Newton, PHD
role: PRINCIPAL_INVESTIGATOR
References: