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

Lovoria Williams

Status: Active, not recruiting

Conditions: Diabetes

Treatments: Behavioral: DPP-GLB Enhanced; Behavioral: DPP-GLB Standard

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04757519

58766

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

Details and patient eligibility

About

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.

Enrollment: 403 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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403 participants in 2 patient groups

DPP-GLB Standard

Experimental group

Description:

Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.

Treatment:

Behavioral: DPP-GLB Standard

DPP-GLB Enhanced

Experimental group

Description:

Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.

Treatment:

Behavioral: DPP-GLB Enhanced