Enhancing the Diabetes Prevention Program to Promote Weight Loss Among Nonresponders in a Community-Based Lifestyle Intervention.
Overview
- Phase
- Not Applicable
- Intervention
- DPP-GLB Standard
- Conditions
- Diabetes
- Sponsor
- Lovoria Williams
- Enrollment
- 403
- Locations
- 21
- Primary Endpoint
- Change in Weight at 6 Months
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Lovoria Williams
Associate Professor
University of Kentucky
Eligibility Criteria
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
Arms & Interventions
DPP-GLB Standard
Participants in this group will receive the standard Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
Intervention: DPP-GLB Standard
DPP-GLB Enhanced
Participants in this group will receive the enhanced Diabetes Prevention Program Group Lifestyle Balance (DPP-GLP) Intervention Program.
Intervention: DPP-GLB Enhanced
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Change in Blood Pressure at 6 Months(6 months (at baseline and 6 months))
- Change in Blood Pressure at 12 Weeks(12 weeks (at baseline and 12 weeks))
- Impact of Weight on Quality of Life(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))
- Change in Dietary Intake at 6 Months(6 months (at baseline, 12 weeks, 6 months))
- Cost Analysis(6 months)