Enhanced DPP-GLB to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.
Enhancing the Diabetes Prevention Program to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.
2 other identifiers
interventional
403
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Feb 2021
Longer than P75 for not_applicable diabetes
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2021
CompletedFirst Posted
Study publicly available on registry
February 17, 2021
CompletedStudy Start
First participant enrolled
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2024
CompletedResults Posted
Study results publicly available
January 23, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJanuary 23, 2026
January 1, 2026
3.8 years
January 28, 2021
December 1, 2025
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Weight at 12 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
Weight will be measured in pounds using a cellular scale at baseline and at 6 months.
6 months (at baseline and 6 months)
Secondary Outcomes (8)
Change in Blood Pressure at 12 Weeks
12 weeks (at baseline and 12 weeks)
Change in Blood Pressure at 6 Months
6 months (at baseline and 6 months)
Change in Physical Activity at 12 Weeks
12 weeks (at baseline and 12 weeks)
Change in Physical Activity at 6 Months
6 months (at baseline and 6 months)
Change in Dietary Intake at 12 Weeks
12 weeks (at baseline and 12 weeks)
- +3 more secondary outcomes
Study Arms (2)
DPP-GLB Standard
EXPERIMENTALParticipants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
DPP-GLB Enhanced
EXPERIMENTALParticipants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
First Corinthian Baptist Church
Frankfort, Kentucky, 40601, United States
Heavenly Outpour
Frankfort, Kentucky, 40601, United States
Consolidated Baptist Church
Lexington, Kentucky, 40505, United States
Historic St. Paul AME Church
Lexington, Kentucky, 40507, United States
First African Baptist Church
Lexington, Kentucky, 40508, United States
Pilgrim Baptist Church
Lexington, Kentucky, 40508, United States
Shiloh Baptist Church
Lexington, Kentucky, 40508, United States
Redeemed Christian Church of God
Lexington, Kentucky, 40509, United States
First Baptist Church Brackstown
Lexington, Kentucky, 40511, United States
Lima Drive Seventh Day Adventist Church
Lexington, Kentucky, 40511, United States
Kingdom Fellowship
Louisville, Kentucky, 40202, United States
Bates Memorial Baptist Church
Louisville, Kentucky, 40203, United States
St. Stephen Baptist Church
Louisville, Kentucky, 40210, United States
Greater Gaililee CDC
Louisville, Kentucky, 40211, United States
Historic Calvary MBC
Louisville, Kentucky, 40211, United States
Spirit Filled New Life Church
Louisville, Kentucky, 40214, United States
Forest Baptist Church
Louisville, Kentucky, 40218, United States
Burnett Ave BC
Louisville, Kentucky, 40291, United States
Marnel C. Moorman Family Life Center
Shelbyville, Kentucky, 40065, United States
New Mt. Zion Baptist Church
Shelbyville, Kentucky, 40065, United States
First Baptist Winchester
Winchester, Kentucky, 40391, United States
Related Publications (1)
Williams LB, Moser DK, Gustafson A, Waters TM, Rayens MK, Karle ER, Kriska AM. Reaching high-risk Black adults for diabetes prevention programming during a pandemic: The design of Fit & Faithful a randomized controlled community trial. Contemp Clin Trials. 2022 Dec;123:106973. doi: 10.1016/j.cct.2022.106973. Epub 2022 Nov 5.
PMID: 36334705DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Lovoria Williams
- Organization
- University of Kentucky College of Nursing
Study Officials
- PRINCIPAL INVESTIGATOR
Lovoria Williams
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 28, 2021
First Posted
February 17, 2021
Study Start
February 18, 2021
Primary Completion
December 4, 2024
Study Completion (Estimated)
June 30, 2026
Last Updated
January 23, 2026
Results First Posted
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share