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ACTIVE NOT RECRUITING
NCT04757519
NA

Enhanced DPP-GLB to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.

Sponsor: Lovoria Williams

View on ClinicalTrials.gov

Summary

This study seeks to establish the efficacy of identifying weight loss nonresponders early in a Diabetes Prevention Program (DPP) intervention in 20 community settings (primarily churches and community centers) and providing them with individual-level, enhanced treatment through telephone contacts and access to additional resources. Additionally, potential mediators and moderators of the relationship between intervention status and weight loss response at 6 months in both nonresponders and responders will be examined and a cost-effectiveness analysis to evaluate the cost of the intervention will be conducted. This study addresses key gaps in the literature about the weight loss effects of identifying nonresponders early and characterizing individuals who need more intense personalized strategies. The investigators hypothesize that changes between baseline and 3 months will be more pronounced among the nonresponders in the intervention group compared to the nonresponders in the active control group.

Official title: Enhancing the Diabetes Prevention Program to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

403

Start Date

2021-02-18

Completion Date

2026-06-30

Last Updated

2026-01-23

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

DPP-GLB Standard

The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.

BEHAVIORAL

DPP-GLB Enhanced

The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.

Locations (21)

First Corinthian Baptist Church

Frankfort, Kentucky, United States

Heavenly Outpour

Frankfort, Kentucky, United States

Consolidated Baptist Church

Lexington, Kentucky, United States

Historic St. Paul AME Church

Lexington, Kentucky, United States

First African Baptist Church

Lexington, Kentucky, United States

Pilgrim Baptist Church

Lexington, Kentucky, United States

Shiloh Baptist Church

Lexington, Kentucky, United States

Redeemed Christian Church of God

Lexington, Kentucky, United States

First Baptist Church Brackstown

Lexington, Kentucky, United States

Lima Drive Seventh Day Adventist Church

Lexington, Kentucky, United States

Kingdom Fellowship

Louisville, Kentucky, United States

Bates Memorial Baptist Church

Louisville, Kentucky, United States

St. Stephen Baptist Church

Louisville, Kentucky, United States

Greater Gaililee CDC

Louisville, Kentucky, United States

Historic Calvary MBC

Louisville, Kentucky, United States

Spirit Filled New Life Church

Louisville, Kentucky, United States

Forest Baptist Church

Louisville, Kentucky, United States

Burnett Ave BC

Louisville, Kentucky, United States

Marnel C. Moorman Family Life Center

Shelbyville, Kentucky, United States

New Mt. Zion Baptist Church

Shelbyville, Kentucky, United States

First Baptist Winchester

Winchester, Kentucky, United States