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

Sponsor

Klein Buendel, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03055416

Collaborator

Pennington Biomedical Research Center (Other)

Enrollment

Locations

Arm

19.9

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2016

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Mobile Men App Prototype

Prototype of physical activity mobile app geared for African-American men.

Other: Mobile Men App Prototype

Testing of app functionality

Outcome Measures

Primary Outcome Measures

System Usability Questionnaire [5 months]
Participant perspective of program feasibility and physical activity promotion.

Secondary Outcome Measures

User Perspectives Survey [5 months]
Participant perspective of app's design and identifying and correcting usability problems.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

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.