Clinical trial NCT05621044: Physical Activity Smartphone App for African American Men (FitBros) Ph II
Official title: Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) Phase II
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Exercise
Health Behavior
Technology
Lead sponsor: Klein Buendel, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pennington Biomedical Research Center
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Georgetown University
First posted: 2022-11-17
Enrollment: 100
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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 (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).

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

Primary outcomes:
measure: Change from Baseline in Physical activity-Acti Graph at 9 Months
timeFrame: Baseline and 9 months
Secondary outcomes:
measure: Change from Baseline in Weight at 9 Months
timeFrame: Baseline and 9 months
measure: Change from Baseline in Blood Pressure at 9 months
timeFrame: Baseline and 9 months
measure: Change from Baseline in Quality of Life Assessment at 9 Months
timeFrame: Baseline and 9 months
measure: Change from Baseline in Dietary Habits at 9 Months
timeFrame: Baseline and 9 months
measure: Satisfaction Assessment
timeFrame: 9 months
measure: System Usability Scale (SUS)
timeFrame: 9 months
measure: FitBrothers App Usage
timeFrame: 9 months
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: