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The Inspiring Action to Prevent Diabetes Intervention (INSPIRA)

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University of Michigan

Status

Active, not recruiting

Conditions

PreDiabetes

Treatments

Behavioral: INSPIRA
Behavioral: Diabetes Prevention Program

Study type

Interventional

Funder types

Other

Identifiers

NCT06001801
HUM00227197

Details and patient eligibility

About

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.

Enrollment

142 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

142 participants in 2 patient groups

Diabetes Prevention Program (DPP) (usual care)
Active Comparator group
Treatment:
Behavioral: Diabetes Prevention Program
DPP plus the INSPIRA intervention
Experimental group
Description:
This arm will include the DPP plus additional interventions.
Treatment:
Behavioral: Diabetes Prevention Program
Behavioral: INSPIRA

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Shelley Stoll, MPH

Data sourced from clinicaltrials.gov

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