ExerciseFitBrosNCT05509712
Physical Activity Smartphone App for African American Men (FitBros) Phase I
An observational study of Exercise and Health Behavior, run by Klein Buendel, Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise, Health Behavior, Technology
- What is being tested?
- Focus Groups to Refine MobileMen App Content and Beta testing of MobileMen App Prototype
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Mar 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: African-American Men
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Klein Buendel, Inc
Golden, Colorado, 80401
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: 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.
Read the 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
- Being tested
- Focus Groups to Refine MobileMen App Content, Beta testing of MobileMen App Prototype
- Medical subject headings
- Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus Groups to Refine MobileMen App ContentBehavioural
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 PrototypeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Focus Groups to Refine MobileMen App Content | |
| 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 Receives: Behavioral: Beta testing of MobileMen App Prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formative Research
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.
Measured: Baseline
Formative Evaluation
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.
Measured: Baseline
Usability
Usability is assessed by the 10-item System Usability Scale (SUS).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start7 Mar 2022
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Georgetown University, Pennington Biomedical Research Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Robert Newton, PHD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509712
- Sponsor's protocol ID
- 0334
- Other IDs
- 1R42MD0014947-01A1
- Acronym
- FitBros
- Status last verified
- Jul 2023
- First submitted
- 15 Mar 2022
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone App to Increase and Maintain Physical Activity in African American Men (FitBrothers) Phase I
- ClinicalTrials.gov ID
- NCT05509712
- Acronym / sponsor ID
- FitBros / 0334
- Conditions
- Exercise, Health Behavior, Technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Georgetown University, Pennington Biomedical Research Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus Groups to Refine MobileMen App Content | – | Behavioral: Focus Groups to Refine MobileMen App ContentFocus 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. |
| Beta testing of MobileMen App Prototype | – | Behavioral: Beta testing of MobileMen App PrototypeThe 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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- African-American Men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus Groups to Refine MobileMen App ContentParticipants 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). | Behavioural | Focus Groups to Refine MobileMen App Content |
| Beta testing of MobileMen App PrototypeProject 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. | Behavioural | Beta testing of MobileMen App Prototype |
Primary outcome
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.
Usability
Time frame: Baseline
Usability is assessed by the 10-item System Usability Scale (SUS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Newton, PHD principal investigator
Pennington Biomedical Research Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise and Health Behavior, run by Klein Buendel, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Formative Research (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.