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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169947
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Weight loss core Behavioral: Weight loss core plus maintenance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 425 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in weight from 6 months to 18 months [ Time Frame: Change from 6 months to 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169947


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Karen Yeary, PhD University of Arkansas
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02169947    
Other Study ID Numbers: 134125
2P20MD002329-06 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight