Overview

This trial is active, not recruiting.

Condition obesity
Treatments weight loss core, weight loss core plus maintenance
Sponsor University of Arkansas
Collaborator National Institute on Minority Health and Health Disparities (NIMHD)
Start date March 2012
End date December 2017
Trial size 450 participants
Trial identifier NCT02169947, 134125, 2P20MD002329-06

Summary

The WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study in rural, African American adults of faith. The study will see whether a weight loss + maintenance intervention will cause participants to maintain their weight better than a weight loss only intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program.
weight loss core
The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.
(Experimental)
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program PLUS 12 maintenance sessions.
weight loss core
The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.
weight loss core plus maintenance
The intervention is a culturally adapted version of the Diabetes Prevention Program core 16 sessions plus 12 maintenance sessions.

Primary Outcomes

Measure
Change in weight from 6 months to 18 months
time frame: Change from 6 months to 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - African American - Aged 18 and older - Have a BMI ) > 25 kg/m² - Associated with a participating church through membership or participation in a church activity - Free of medical problems that might contraindicated participation in a behavioral weight reduction program containing an exercise component - Individuals taking sulfonylureas who have a letter from their doctor supporting their participation in the study will be considered eligible Exclusion Criteria - Not had a heart attack or stroke in the past 6 months - Not currently on medication that might affect weight loss or require medical monitoring (i.e. insulin) - Not pregnant, not pregnant in the previous six months, or lactating - Not enrolled in another weight reduction program - Agree to complete the program assigned to them - Never had weight loss surgery - Not have lost more than 10% body weight in the previous 6 months - Not have a clinically significant medical condition likely to impact weight or any condition that makes it unlikely the participant would be available to follow the protocol for 18 months

Additional Information

Official title Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
Principal investigator Karen Yeary, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Arkansas.