Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD) (WORD)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss core
Weight loss core plus maintenance
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Weight loss core
Weight loss core plus maintenance
Arm Description
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program.
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program PLUS 12 maintenance sessions.
Outcomes
Primary Outcome Measures
Change in weight from 6 months to 18 months
Secondary Outcome Measures
Full Information
NCT ID
NCT02169947
First Posted
June 17, 2014
Last Updated
March 28, 2018
Sponsor
University of Arkansas
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT02169947
Brief Title
Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
Acronym
WORD
Official Title
Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2012 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
425 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight loss core
Arm Type
Active Comparator
Arm Description
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program.
Arm Title
Weight loss core plus maintenance
Arm Type
Experimental
Arm Description
Participants will receive a culturally adapted version of the Diabetes Prevention Program core (16 session) program PLUS 12 maintenance sessions.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss core
Intervention Description
The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss core plus maintenance
Intervention Description
The intervention is a culturally adapted version of the Diabetes Prevention Program core 16 sessions plus 12 maintenance sessions.
Primary Outcome Measure Information:
Title
Change in weight from 6 months to 18 months
Time Frame
Change from 6 months to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Yeary, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
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