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Mobile Phone Intervention for Physical Activity Maintenance in African American Men (MobileMen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03055416
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : December 12, 2018
Pennington Biomedical Research Center
Information provided by (Responsible Party):
Klein Buendel, Inc.

Brief Summary:
African American men are at risk of developing chronic disease partly due to low levels of regular physical activity. Studies have been effective in increasing physical activity levels in African American men; however for the health benefits of exercise to be maintained continued physical activity is necessary. The purpose of the current study is to develop a mobile phone application for African American men that will help them maintain their physical activity levels.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Other: Mobile Men App Prototype Not Applicable

Detailed Description:
African American men experience health disparities across a number of preventable chronic diseases, including cardiovascular disease, strokes, obesity, and diabetes. Physical activity (PA) is a modifiable risk factor for these conditions. The few PA promotion studies that have included African American men have resulted in successful short-term behavior change, yet in order for the health benefits of PA to be realized, PA levels must be maintained. While behavior change maintenance programs have been shown to assist participants in sustaining behavior change, we were unable to identify any studies that have developed maintenance programs specifically targeting African American men. The purpose of this proposal is to develop a PA maintenance program for African American men. This Phase I Small Business Technology Transfer (STTR) project, MobileMen, will deliver the intervention utilizing mobile health (mHealth) technology and therefore, will be led by researchers and multimedia developers at Klein Buendel, Inc. (KB) and Pennington Biomedical Research Center (Dr. Newton, PI). 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. There is a need to tailor this intervention towards African American men because they have unique gender role beliefs which influence exercise promotion. There is also increasing recognition of the need for researchers to develop interventions in collaboration with the target population. Therefore, the current proposal will involve conducting formative research with African American men to identify the key elements for program development. 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 usable. In this Phase I STTR, KB will: (1) conduct multi-method formative research to guide app design and content, (2) produce a functioning app prototype, and (3) conduct usability testing on the prototype for functionality, ease of use, and interest among African American men. To KB's knowledge, no study has utilized mobile phones as a means of effecting PA levels in African American men. MobileMen will address an unmet need in the marketplace as it will be the first smartphone app that is targeted toward PA maintenance in African American men.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mobile Phone Intervention for Physical Activity Maintenance in African American Men (MobileMen)
Study Start Date : September 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Mobile Men App Prototype
Prototype of physical activity mobile app geared for African-American men.
Other: Mobile Men App Prototype
Testing of app functionality

Primary Outcome Measures :
  1. System Usability Questionnaire [ Time Frame: 5 months ]
    Participant perspective of program feasibility and physical activity promotion.

Secondary Outcome Measures :
  1. User Perspectives Survey [ Time Frame: 5 months ]
    Participant perspective of app's design and identifying and correcting usability problems.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Owns a smartphone and speaks and reads English, lives in the Greater Baton Rouge area, and consents to participate.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03055416

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United States, Colorado
Klein Buendel, Inc.
Golden, Colorado, United States, 80401
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70803
Sponsors and Collaborators
Klein Buendel, Inc.
Pennington Biomedical Research Center
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Principal Investigator: Robert Newton, PhD Pennington Biomedical Research Center

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Responsible Party: Klein Buendel, Inc. Identifier: NCT03055416    
Other Study ID Numbers: 1R41MD010304-01A1 ( U.S. NIH Grant/Contract )
0312 ( Other Identifier: Klein Buendel, Inc. )
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Klein Buendel, Inc.:
Physical Activity
African-American Men
Mobile Health
Additional relevant MeSH terms:
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Body Weight