NCT02169947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

5.8 years

First QC Date

June 17, 2014

Last Update Submit

March 28, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in weight from 6 months to 18 months

    Change from 6 months to 18 months

Study Arms (2)

Weight loss core

ACTIVE COMPARATOR

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

Behavioral: Weight loss core

Weight loss core plus maintenance

EXPERIMENTAL

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

Behavioral: Weight loss coreBehavioral: Weight loss core plus maintenance

Interventions

Weight loss coreBEHAVIORAL

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

Weight loss coreWeight loss core plus maintenance
Weight loss core plus maintenanceBEHAVIORAL

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

Weight loss core plus maintenance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Maintenance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Karen Yeary, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 23, 2014

Study Start

May 1, 2012

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

US(1)