Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DPP-GLB Enhanced | Behavioral | — | UNRESOLVED |
| DPP-GLB Standard | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DPP-GLB Standard
- description
- Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
- interventionNames
- Behavioral: DPP-GLB Standard
- type
- EXPERIMENTAL
- label
- DPP-GLB Enhanced
- description
- Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
- interventionNames
- Behavioral: DPP-GLB Enhanced
Primary outcomes (2)
- measure
- Change in Weight at 12 Weeks
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWilliams 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 36334705