The Inspiring Action to Prevent Diabetes Intervention

NCT06001801 | Active Not Recruiting

• 1 other identifier: HUM00227197
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Keywords

Diabetes Prevention Program; Behaviors; Weight loss; Healthy lifestyle changes; Peer Partner

Outcome Measures

Primary Outcomes (1)

• Number of group sessions attended by participants

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

  6 months

Secondary Outcomes (4)

• 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 Arms (2)

Diabetes Prevention Program (DPP) (usual care)

ACTIVE COMPARATOR

Behavioral: Diabetes Prevention Program

DPP plus the INSPIRA intervention

EXPERIMENTAL

This arm will include the DPP plus additional interventions.

Behavioral: Diabetes Prevention Program; Behavioral: INSPIRA

Interventions

Diabetes Prevention Program 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; Diabetes Prevention Program (DPP) (usual care)

INSPIRA 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.

DPP plus the INSPIRA intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• American Diabetes Association: collaborator

Study Sites (1)

Community Health and Social Services Center, Incorporated

Detroit, Michigan, 48209, United States

Location

MeSH Terms

Conditions

Prediabetic State; Behavior; Weight Loss

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Ellen M Heisler, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: September 18, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)