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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Klein Buendel, Inc
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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).
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
Usability
Time Frame: Baseline
Usability is assessed by the 10-item System Usability Scale (SUS).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klein Buendel, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Georgetown University
National Institute on Minority Health and Health Disparities (NIMHD)
Pennington Biomedical Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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