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

January 6, 2026 updated by: Lovoria Williams

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

403

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Frankfort, Kentucky, United States, 40601
        • First Corinthian Baptist Church
      • Frankfort, Kentucky, United States, 40601
        • Heavenly Outpour
      • Lexington, Kentucky, United States, 40505
        • Consolidated Baptist Church
      • Lexington, Kentucky, United States, 40507
        • Historic St. Paul AME Church
      • Lexington, Kentucky, United States, 40508
        • First African Baptist Church
      • Lexington, Kentucky, United States, 40508
        • Pilgrim Baptist Church
      • Lexington, Kentucky, United States, 40508
        • Shiloh Baptist Church
      • Lexington, Kentucky, United States, 40509
        • Redeemed Christian Church of God
      • Lexington, Kentucky, United States, 40511
        • First Baptist Church Brackstown
      • Lexington, Kentucky, United States, 40511
        • Lima Drive Seventh Day Adventist Church
      • Louisville, Kentucky, United States, 40202
        • Kingdom Fellowship
      • Louisville, Kentucky, United States, 40203
        • Bates Memorial Baptist Church
      • Louisville, Kentucky, United States, 40210
        • St. Stephen Baptist Church
      • Louisville, Kentucky, United States, 40211
        • Greater Gaililee CDC
      • Louisville, Kentucky, United States, 40211
        • Historic Calvary MBC
      • Louisville, Kentucky, United States, 40214
        • Spirit Filled New Life Church
      • Louisville, Kentucky, United States, 40218
        • Forest Baptist Church
      • Louisville, Kentucky, United States, 40291
        • Burnett Ave BC
      • Shelbyville, Kentucky, United States, 40065
        • Marnel C. Moorman Family Life Center
      • Shelbyville, Kentucky, United States, 40065
        • New Mt. Zion Baptist Church
      • Winchester, Kentucky, United States, 40391
        • First Baptist Winchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • self-described as Black
  • non-diabetic
  • body mass index (BMI) equal to or greater than 25
  • CDC diabetes risk assessment greater than or equal to 5 or diabetes pre-diagnosis or history of gestational diabetes
  • live within driving distance of participating church/site

Exclusion Criteria:

  • diagnosed Type 1 or 2 diabetes
  • pregnant or planning to become pregnant during study period
  • contraindications to moderate physical activity
  • serious medical condition that contradicts weight loss
  • not Black or African American

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DPP-GLB Standard
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
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.
Experimental: DPP-GLB Enhanced
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weight at 12 Weeks
Time Frame: 12 weeks (at baseline and12 weeks)
Weight will be measured in pounds using a cellular scale at baseline and at 12 weeks.
12 weeks (at baseline and12 weeks)
Change in Weight at 6 Months
Time Frame: 6 months (at baseline and 6 months)
Weight will be measured in pounds using a cellular scale at baseline and at 6 months.
6 months (at baseline and 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure at 12 Weeks
Time Frame: 12 weeks (at baseline and 12 weeks)
Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 12 weeks.
12 weeks (at baseline and 12 weeks)
Change in Blood Pressure at 6 Months
Time Frame: 6 months (at baseline and 6 months)
Blood pressure will be measured with calibrated automated blood pressure monitor at baseline and at 6 months.
6 months (at baseline and 6 months)
Impact of Weight on Quality of Life
Time Frame: 6 months
Quality of life will be measured using Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite). This is a 31-item self-report scale. Scores range from 0-100; higher scores indicate greater quality of life.
6 months
Change in Physical Activity at 12 Weeks
Time Frame: 12 weeks (at baseline and 12 weeks)
Change in Physical Activity will be measured at baseline and 12-week using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration across the leisure and occupational components. Responses were converted to metabolic equivalent hours per week (MET-hrs/week) using standard scoring procedures, where higher MET-hrs/week indicates greater physical activity.
12 weeks (at baseline and 12 weeks)
Change in Physical Activity at 6 Months
Time Frame: 6 months (at baseline and 6 months)
Change in Physical Activity will be measured at baseline and 6-month using the Modifiable Activity Questionnaire (MAQ), which assesses activity frequency and duration across the leisure and occupational components. Responses were converted to metabolic equivalent hours per week (MET-hrs/week) using standard scoring procedures, where higher MET-hrs/week indicates greater physical activity.
6 months (at baseline and 6 months)
Change in Dietary Intake at 12 Weeks
Time Frame: 12 weeks (at baseline and 12 weeks)
Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake. The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.
12 weeks (at baseline and 12 weeks)
Change in Dietary Intake at 6 Months
Time Frame: 6 months (at baseline, 12 weeks, 6 months)
Change in Dietary Intake will be measured using the validated, Dana Farber eating habits tool and the Dietary screener questionnaire which assesses the frequency of consumption of selected foods and drinks. The scoring range of the survey is Never or less than once per month, 1-3 per month, 1 per week, 2-4 per week, 5-6 per week, 1 per day, 2-3 per day, 4-5 per day, 6 or more per day, Prefer not to answer. Higher scores indicated increased dietary intake.The total score is the sum of the scores on all items, divided by the total maximum score possible, and then multiplied by 100.
6 months (at baseline, 12 weeks, 6 months)
Cost Analysis
Time Frame: 6 months
Investigator-developed instrument. At 6 months, conduct a cost-effectiveness analysis to evaluate the cost of the intervention arm by comparing the incremental cost and weight loss with the active control arm. The generated final output is the cost per participant in dollars.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lovoria Williams

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Lovoria Williams, University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2021

Primary Completion (Actual)

December 4, 2024

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58766
  • 1R01DK125801-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on DPP-GLB Standard

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe