The Inspiring Action to Prevent Diabetes Intervention

PreDiabetes Clinical Trial

— INSPIRA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06001801
• Other study ID #: HUM00227197
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: September 2026

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 142
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Community Health and Social Services Center, Incorporated	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Weight will be measured in pounds.	baseline, 6 months
Secondary	Change in hemoglobin A1c		baseline, 6 months
Secondary	Change in waist circumference	This will be measured in centimeters.	baseline, 6 months
Secondary	Number of group sessions attended by participants		6 months
Secondary	Change in reported diet quality	measured by comparing baseline and six month survey responses	baseline, 6 months