CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 380 enrolled
Drug / intervention
Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03270436
NCT03270436N/ACompleted

Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population

University of Arkansas·interventional·Posted Sep 1, 2017·Updated Dec 9, 2020

In Brief

A clinical study evaluating Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program and Partnership for Improving Lifestyle Intervention Diabetes Prevention Program for Diabetes Mellitus, Type 2. Completed, enrolled 380 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 1, 2017
Enrollment StartJan 8, 2018
Primary CompletionMay 14, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.8 years ago

Interventions

Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Programbehavioral

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

Partnership for Improving Lifestyle Intervention Diabetes Prevention Programbehavioral

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