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

University of Arkansas

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Weight loss core plus maintenance; Behavioral: Weight loss core

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02169947

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

134125

Details and patient eligibility

About

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.

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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425 participants in 2 patient groups

Weight loss core

Active Comparator group

Description:

Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program.

Treatment:

Behavioral: Weight loss core

Weight loss core plus maintenance

Experimental group

Description:

Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program PLUS 12 maintenance sessions.

Treatment:

Behavioral: Weight loss core

Behavioral: Weight loss core plus maintenance