NCT03055416

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

2 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

September 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

January 16, 2017

Last Update Submit

February 7, 2023

Conditions

Overweight and Obesity

Keywords

OverweightObesityPhysical ActivityAfrican-American MenmHealthMobile Health

Outcome Measures

Primary Outcomes (1)

  • System Usability Questionnaire

    Participant perspective of program feasibility and physical activity promotion.

    5 months

Secondary Outcomes (1)

  • User Perspectives Survey

    5 months

Study Arms (1)

Mobile Men App Prototype

OTHER

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

Other: Mobile Men App Prototype

Interventions

Mobile Men App PrototypeOTHER

Testing of app functionality

Mobile Men App Prototype

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70803, United States

Location

Related Publications (6)

  • 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.

    PMID: 22179539BACKGROUND

  • 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.

    PMID: 20067953BACKGROUND

  • 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.

    PMID: 22617494BACKGROUND

  • 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.

    PMID: 16009797BACKGROUND

  • 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.

    PMID: 16103523BACKGROUND

  • 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.

    PMID: 25196408BACKGROUND

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Robert Newton, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2017

First Posted

February 16, 2017

Study Start

September 1, 2016

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)