The Inspiring Action to Prevent Diabetes Intervention

NCT ID: NCT06001801

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2025-12-31

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.

Conditions

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Diabetes Prevention Program (DPP) (usual care)

Group Type: ACTIVE_COMPARATOR

Diabetes Prevention Program

Intervention Type: BEHAVIORAL

The DPP group is led by the Community Health and Social Services Center (CHASS) community health workers (CHWs). For this study, the workers will deliver 16 weekly sessions (core phase) followed by two monthly sessions (maintenance phase). Each session lasts one hour plus the time required to weigh each participant and review food and activity logs.

This program will help participants make healthy lifestyle changes. Examples are improvements in eating and physical activity. The goal is that participants lose some weight and eat healthier food.

Sessions will be offered in-person in a room with video capacity to allow attendance of participants that cannot attend in person. For those participating virtually, the CHWs will briefly review with them what participants logged.

Participation in this project should last approximately 6-months.

DPP plus the INSPIRA intervention

This arm will include the DPP plus additional interventions.

Group Type: EXPERIMENTAL

Diabetes Prevention Program

Intervention Type: BEHAVIORAL

The DPP group is led by the Community Health and Social Services Center (CHASS) community health workers (CHWs). For this study, the workers will deliver 16 weekly sessions (core phase) followed by two monthly sessions (maintenance phase). Each session lasts one hour plus the time required to weigh each participant and review food and activity logs.

This program will help participants make healthy lifestyle changes. Examples are improvements in eating and physical activity. The goal is that participants lose some weight and eat healthier food.

Sessions will be offered in-person in a room with video capacity to allow attendance of participants that cannot attend in person. For those participating virtually, the CHWs will briefly review with them what participants logged.

Participation in this project should last approximately 6-months.

INSPIRA

Intervention Type: BEHAVIORAL

This intervention will include the DPP plus additional interventions. The additional interventions include: participants to stay for an extra 30 minutes following the regular DPP sessions. In these INSPIRA sessions, participants will be trained in providing mutual peer support, be matched with a peer partner and asked to talk at least once a week, receive vouchers or gift cards, discuss participants action plans with the peer partner, and share challenges, successes, and tips from the CHW and others in the session.

CHWs will provide brief trainings on autonomy-supportive peer support approaches over the first three weeks of sessions.

Participation in this project should last approximately 6-months.

Interventions

Diabetes Prevention Program

The DPP group is led by the Community Health and Social Services Center (CHASS) community health workers (CHWs). For this study, the workers will deliver 16 weekly sessions (core phase) followed by two monthly sessions (maintenance phase). Each session lasts one hour plus the time required to weigh each participant and review food and activity logs.

This program will help participants make healthy lifestyle changes. Examples are improvements in eating and physical activity. The goal is that participants lose some weight and eat healthier food.

Sessions will be offered in-person in a room with video capacity to allow attendance of participants that cannot attend in person. For those participating virtually, the CHWs will briefly review with them what participants logged.

Participation in this project should last approximately 6-months.

Intervention Type: BEHAVIORAL

INSPIRA

This intervention will include the DPP plus additional interventions. The additional interventions include: participants to stay for an extra 30 minutes following the regular DPP sessions. In these INSPIRA sessions, participants will be trained in providing mutual peer support, be matched with a peer partner and asked to talk at least once a week, receive vouchers or gift cards, discuss participants action plans with the peer partner, and share challenges, successes, and tips from the CHW and others in the session.

CHWs will provide brief trainings on autonomy-supportive peer support approaches over the first three weeks of sessions.

Participation in this project should last approximately 6-months.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Mary Ellen Michele Heisler

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Ellen M Heisler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Community Health and Social Services Center, Incorporated

Detroit, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00227197

Identifier Type: -

Identifier Source: org_study_id