Mobile Phone Intervention for Physical Activity Maintenance in African American Men (MobileMen)
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Men App Prototype
Sponsored by

About this trial
This is an interventional other trial for Overweight and Obesity focused on measuring Overweight, Obesity, Physical Activity, African-American Men, mHealth, Mobile Health
Eligibility Criteria
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.
Sites / Locations
- Klein Buendel, Inc.
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Mobile Men App Prototype
Arm Description
Prototype of physical activity mobile app geared for African-American men.
Outcomes
Primary Outcome Measures
System Usability Questionnaire
Participant perspective of program feasibility and physical activity promotion.
Secondary Outcome Measures
User Perspectives Survey
Participant perspective of app's design and identifying and correcting usability problems.
Full Information
NCT ID
NCT03055416
First Posted
January 16, 2017
Last Updated
February 7, 2023
Sponsor
Klein Buendel, Inc.
Collaborators
Pennington Biomedical Research Center, National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT03055416
Brief Title
Mobile Phone Intervention for Physical Activity Maintenance in African American Men (MobileMen)
Official Title
Mobile Phone Intervention for Physical Activity Maintenance in African American Men (MobileMen) Ph I
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klein Buendel, Inc.
Collaborators
Pennington Biomedical Research Center, National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Overweight, Obesity, Physical Activity, African-American Men, mHealth, Mobile Health
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Men App Prototype
Arm Type
Other
Arm Description
Prototype of physical activity mobile app geared for African-American men.
Intervention Type
Other
Intervention Name(s)
Mobile Men App Prototype
Intervention Description
Testing of app functionality
Primary Outcome Measure Information:
Title
System Usability Questionnaire
Description
Participant perspective of program feasibility and physical activity promotion.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
User Perspectives Survey
Description
Participant perspective of app's design and identifying and correcting usability problems.
Time Frame
5 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Newton, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klein Buendel, Inc.
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22179539
Citation
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available. Erratum In: Circulation. 2012 Jun 5;125(22):e1002.
Results Reference
background
PubMed Identifier
20067953
Citation
Cowie CC, Rust KF, Byrd-Holt DD, Gregg EW, Ford ES, Geiss LS, Bainbridge KE, Fradkin JE. Prevalence of diabetes and high risk for diabetes using A1C criteria in the U.S. population in 1988-2006. Diabetes Care. 2010 Mar;33(3):562-8. doi: 10.2337/dc09-1524. Epub 2010 Jan 12.
Results Reference
background
PubMed Identifier
22617494
Citation
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009-2010. NCHS Data Brief. 2012 Jan;(82):1-8.
Results Reference
background
PubMed Identifier
16009797
Citation
LaMonte MJ, Barlow CE, Jurca R, Kampert JB, Church TS, Blair SN. Cardiorespiratory fitness is inversely associated with the incidence of metabolic syndrome: a prospective study of men and women. Circulation. 2005 Jul 26;112(4):505-12. doi: 10.1161/CIRCULATIONAHA.104.503805. Epub 2005 Jul 11.
Results Reference
background
PubMed Identifier
16103523
Citation
LaMonte MJ, Blair SN, Church TS. Physical activity and diabetes prevention. J Appl Physiol (1985). 2005 Sep;99(3):1205-13. doi: 10.1152/japplphysiol.00193.2005.
Results Reference
background
PubMed Identifier
25196408
Citation
Newton RL Jr, Griffith DM, Kearney WB, Bennett GG. A systematic review of weight loss, physical activity and dietary interventions involving African American men. Obes Rev. 2014 Oct;15 Suppl 4:93-106. doi: 10.1111/obr.12209.
Results Reference
background
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Mobile Phone Intervention for Physical Activity Maintenance in African American Men (MobileMen)
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