- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05509712
Physical Activity Smartphone App for African American Men (FitBros) Phase I (FitBros)
July 6, 2023 updated by: Klein Buendel, Inc.
Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) Phase I
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Golden, Colorado, United States, 80401
- Klein Buendel, Inc
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District of Columbia
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Washington, District of Columbia, United States, 20057
- Georgetown University
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
African-American Men
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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).
|
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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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Formative Research
Time Frame: Baseline
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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.
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Baseline
|
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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.
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Baseline
|
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Usability
Time Frame: Baseline
|
Usability is assessed by the 10-item System Usability Scale (SUS).
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Newton, PHD, Pennington Biomedical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
March 15, 2022
First Submitted That Met QC Criteria
August 18, 2022
First Posted (Actual)
August 22, 2022
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
July 6, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 0334
- 1R42MD0014947-01A1 (Other Grant/Funding Number: NIHMD)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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