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Clinical Trials/NCT06001801
NCT06001801Active, not recruitingNot 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 enrollmentStarted: September 18, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
142
Locations
1
Primary Endpoint
Number of group sessions attended by participants

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Diabetes Prevention Program (DPP) (usual care)

Active Comparator

Intervention: Diabetes Prevention Program (Behavioral)

DPP plus the INSPIRA intervention

Experimental

This arm will include the DPP plus additional interventions.

Intervention: Diabetes Prevention Program (Behavioral)

DPP plus the INSPIRA intervention

Experimental

This arm will include the DPP plus additional interventions.

Intervention: INSPIRA (Behavioral)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mary Ellen Michele Heisler

Professor of Internal Medicine

University of Michigan

Study Sites (1)

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