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NCT04082702

Better Me Within Trial to Improve Lifestyle Behaviors in African Americans

Completed NA Last updated 11 December 2019
What this trial tests

NA trial testing Faith-enhanced diabetes prevention program in Obesity in 221 participants. Completed in 31 May 2017.

Timeline
22 February 2013
Primary endpoint
1 May 2017
31 May 2017

Quick facts

Lead sponsorBaylor Research Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment221
Start date22 February 2013
Primary completion1 May 2017
Estimated completion31 May 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Baylor Research Institute

Who can join

Adults 18 to 120, female only, with Obesity or Pre-diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the diabetes prevention program (DPP) for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data. The faith components were specifically linked to weekly DPP learning objectives to strategically emphasize behavioral skills with religious principles. Using a CBPR approach, the Better Me Within trial was able to enroll 12 churches, screen 333 AA women, and randomize 221 after collection of objective eligibility measures. A prospective, randomized, nested by church, design was used to evaluate the faith-enhanced DPP as compared to a standard DPP on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Reducing metabolic syndrome through a community-based lifestyle intervention in African American women.
    Mamun A, Kitzman H, Dodgen L. · · 2020 · cited 19× · PMID 32605881 · DOI 10.1016/j.numecd.2020.06.005

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Other recruiting trials for Obesity

Currently open trials in the same condition.

Other Baylor Research Institute trials

Trials by the same sponsor.

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Data sources for this page

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