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NCT04082702
Better Me Within Trial to Improve Lifestyle Behaviors in African Americans
NA trial testing Faith-enhanced diabetes prevention program in Obesity in 221 participants. Completed in 31 May 2017.
1 May 2017
Quick facts
| Lead sponsor | Baylor Research Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 221 |
| Start date | 22 February 2013 |
| Primary completion | 1 May 2017 |
| Estimated completion | 31 May 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Faith-enhanced diabetes prevention program
- Standard diabetes prevention program
Conditions studied
- Obesity — all drugs for Obesity →
- Pre-diabetes — all drugs for Pre-diabetes →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04082702
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04082702 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baylor Research Institute
- Last refreshed: 11 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04082702.
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