CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 102 enrolled
Drug / intervention
HBHS +2 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/NCT03377244
NCT03377244N/ACompleted

Healthy Body Healthy Souls: A Weight Loss Intervention Using Diabetes Prevention Program Lifestyle Intervention (DPP-LI) With Church Level Systems Change in the Marshallese Population

University of Arkansas·interventional·Posted Dec 19, 2017·Updated Jan 29, 2021

In Brief

A clinical study evaluating HBHS, HBHS Policy, and 1 other intervention for Weight Loss and 2 related conditions. Completed, enrolled 102 participants across 1 site.

Detailed Summary

The primary aim is to pilot test a weight-loss intervention for Marshallese adults, referred to throughout as Healthy Bodies Healthy Souls (HBHS). The HBHS intervention includes the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) implemented at the individual level, with the additional enhancement of working with Marshallese churches to implement church-level changes to support the individual behavioral intervention of the WORD DPP. We will then compare changes in outcomes with participants in the churches who were exposed to the policy changes but did not participate in the WORD DPP, and with those enrolled in a separate DPP trial who participated in the WORD DPP but were not exposed to church-level policy changes.

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 19, 2017
Enrollment StartSep 30, 2018
Primary CompletionOct 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.5 years ago

Interventions

HBHSbehavioral

Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.

HBHS Policybehavioral

Church-level policy changes that encourages participants to engage in healthy behaviors.

WORD DPPbehavioral

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