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

NCT ID: NCT03055416

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight and Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mobile Men App Prototype

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

Group Type OTHER

Mobile Men App Prototype

Intervention Type OTHER

Testing of app functionality

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mobile Men App Prototype

Testing of app functionality

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pennington Biomedical Research Center

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Klein Buendel, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Newton, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klein Buendel, Inc.

Golden, Colorado, United States

Site Status

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22179539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20067953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22617494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16009797 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16103523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25196408 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R41MD010304-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0312

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Stroke and Exercise Program
NCT02701998 UNKNOWN NA
Multiphase Activity Promotion Study
NCT02592590 COMPLETED NA
IT-based Training in Obesity
NCT00899964 COMPLETED NA