Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD) (WORD)

March 28, 2018 updated by: University of Arkansas
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Weight loss core
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program.
Behavioral: Weight loss core
The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.
Experimental: Weight loss core plus maintenance
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program PLUS 12 maintenance sessions.
Behavioral: Weight loss core
The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.
Behavioral: Weight loss core plus maintenance
The intervention is a culturally adapted version of the Diabetes Prevention Program core 16 sessions plus 12 maintenance sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in weight from 6 months to 18 months
Time Frame: Change from 6 months to 18 months
Change from 6 months to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Karen Yeary, PhD, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 134125
  • 2P20MD002329-06 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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