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

NCT ID: NCT02169947

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-01

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Weight loss core

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

Group Type ACTIVE_COMPARATOR

Weight loss core

Intervention Type BEHAVIORAL

The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.

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.

Group Type EXPERIMENTAL

Weight loss core

Intervention Type BEHAVIORAL

The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.

Weight loss core plus maintenance

Intervention Type BEHAVIORAL

The intervention is a culturally adapted version of the Diabetes Prevention Program core 16 sessions plus 12 maintenance sessions.

Interventions

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Weight loss core

The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Yeary, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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2P20MD002329-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

134125

Identifier Type: -

Identifier Source: org_study_id

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