NCT05509712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

March 15, 2022

Last Update Submit

July 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    Baseline

  • Usability

    Usability is assessed by the 10-item System Usability Scale (SUS).

    Baseline

Study Arms (2)

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

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

Interventions

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).

Focus Groups to Refine MobileMen App Content

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.

Beta testing of MobileMen App Prototype

Eligibility Criteria

Age30 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

African-American Men

You may qualify if:

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

You may not qualify if:

  • cognitive impairment that would interfere with participating in a group discussion
  • unwilling to be audio and video-recorded
  • unwilling to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klein Buendel, Inc

Golden, Colorado, 80401, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Motor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Robert Newton, PHD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

August 22, 2022

Study Start

March 7, 2022

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

July 7, 2023

Record last verified: 2023-07

Locations