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Clinical Trials/NCT06001801
NCT06001801
Active, not recruiting
Not Applicable

Leveraging Peer Support and Vouchers for Healthy Food to Increase Engagement in Diabetes Prevention Behaviors Among Low-income Adults With Prediabetes: the INSPIRing Action to Prevent Diabetes (INSPIRA) Intervention

University of Michigan1 site in 1 country142 target enrollmentSeptember 18, 2023
ConditionsPreDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
University of Michigan
Enrollment
142
Locations
1
Primary Endpoint
Number of group sessions attended by participants
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief Summary

This research is studying how to help increase uptake of and engagement in formal Diabetes Prevention Programs to improve healthy behaviors among adults with pre diabetes to reduce risk of getting diabetes.

This project will compare the Diabetes Prevention Program (DPP) to participating in the DPP program plus two extra pieces (INSPIRA). The 2 additional pieces in the DPP plus program includes getting matched with someone else in the program to provide each other support along with a chance to earn healthy food vouchers.

Eligible participants will be randomized to one of the two groups and be asked to participate for approximately 6 months.

Registry
clinicaltrials.gov
Start Date
September 18, 2023
End Date
December 1, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary Ellen Michele Heisler

Professor of Internal Medicine

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • English or Spanish-speaking
  • Body Mass Index (BMI) \> 24.9 kilograms/meters squared (kg/m2)
  • The most recent A1c test, completed in 60 days or fewer prior to enrollment, is 5.7%-6.4%

Exclusion Criteria

  • Diagnosed with schizophrenia
  • Active alcohol or other drug abuse
  • Are pregnant or planning pregnancy in next 6 months
  • Will not be in local area in six months
  • Will not be able to attend sessions, in-person or remotely, for three more weeks

Outcomes

Primary Outcomes

Number of group sessions attended by participants

Time Frame: 6 months

This count will be out of 16 possible weekly group sessions.

Secondary Outcomes

  • Change in weight(baseline, 6 months)
  • Change in hemoglobin A1c(baseline, 6 months)
  • Change in waist circumference(baseline, 6 months)
  • Change in reported diet quality(baseline, 6 months)

Study Sites (1)

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