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

Obesity Clinical Trial

— WORD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169947
• Other study ID #: 134125
• Secondary ID: 2P20MD002329-06
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: March 28, 2018
• Start date: May 1, 2012
• Est. completion date: February 28, 2018

Study information

• Verified date: March 2018
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight from 6 months to 18 months		Change from 6 months to 18 months