The Inspiring Action to Prevent Diabetes Intervention

Not Applicable

• Conditions: PreDiabetes
• Interventions: Behavioral: Diabetes Prevention Program; Behavioral: INSPIRA

• Registration Number: NCT06001801
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Study Start: 2023-09-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPP plus the INSPIRA intervention	Diabetes Prevention Program	This arm will include the DPP plus additional interventions.
DPP plus the INSPIRA intervention	INSPIRA	This arm will include the DPP plus additional interventions.
Diabetes Prevention Program (DPP) (usual care)	Diabetes Prevention Program	-

Primary Outcome Measures

Name	Time	Method
Number of group sessions attended by participants	6 months	This count will be out of 16 possible weekly group sessions.

Secondary Outcome Measures

Name	Time	Method
Change in weight	baseline, 6 months	Weight will be measured in pounds to the nearest tenth.
Change in hemoglobin A1c	baseline, 6 months
Change in waist circumference	baseline, 6 months	This will be measured in centimeters.
Change in reported diet quality	baseline, 6 months	measured by comparing baseline and six month survey responses

Trial Locations

Locations (1)

Community Health and Social Services Center, Incorporated; 🇺🇸 Detroit, Michigan, United States