Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
The investigators will conduct a comparative effectiveness cluster-randomized controlled trial (cRCT) of two Diabetes Prevention Program (DPP) lifestyle interventions: a faith-based intervention (Wholeness, Oneness, Righteousness, Deliverance \[WORD\] DPP); and a Pacific Islander adapted intervention (Partnership for Improving Lifestyle Interventions \[PILI\] DPP. Each intervention lasted 24 weeks and focused on the importance of healthy eating, being physically active, and maintaining a healthy weight. Eligible participants included overweight and obese Marshallese adults living in Arkansas and Oklahoma. The unit of randomization is at the church level. The primary outcome measure is body weight loss (from baseline weight). As selected by stakeholders, HbA1c, blood pressure, physical activity, and dietary intake will be evaluated as secondary outcome measures. Data collection will take place at baseline (pre-intervention), immediate post-intervention (6 months post-initiation of the intervention), and 6 months post-intervention (12 months post-initiation of the intervention).
Key facts
- Study ID
- NCT03270436
- Run by
- University of Arkansas
- People needed
- 380
- Starts
- 2018-01-08
- Expected to finish
- 2020-05-14
- Last updated by the study team
- 2020-12-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Self reported Marshallese
- 18 years of age or older
- BMI greater than or equal to 25
You may not qualify if…
- A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.)
- Currently pregnant or breastfeeding an infant who is 6 months old or younger
- Have any condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, plans to move out of the area within 6 months, an inability to finish the intervention, etc.
Where it is running
- University of Arkansas for Medical Sciences Northwest — Fayetteville, Arkansas, United States
Full record on ClinicalTrials.gov
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