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Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population

NCT03270436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2020-12-09

Study results available
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Summary

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).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program

Faith based diabetes curriculum that teaches participants to connect faith and health.

BEHAVIORAL

Partnership for Improving Lifestyle Intervention Diabetes Prevention Program

Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Pearl McElfish, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2020-05-14
Completion
2020-05-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03270436 on ClinicalTrials.gov