INSPIRA: The Inspiring Action to Prevent Diabetes Intervention

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06001801

Collaborator

American Diabetes Association (Other)

142

Enrollment

Location

Arms

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PreDiabetes	Behavioral: Diabetes Prevention Program Behavioral: INSPIRA	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Diabetes Prevention Program (DPP) (usual care)

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.

Experimental: DPP plus the INSPIRA intervention

This arm will include the DPP plus additional interventions.

Behavioral: Diabetes Prevention Program

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.

Outcome Measures

Primary Outcome Measures

Change in weight [baseline, 6 months]
Weight will be measured in pounds.

Secondary Outcome Measures

Change in hemoglobin A1c [baseline, 6 months]
Change in waist circumference [baseline, 6 months]
This will be measured in centimeters.
Number of group sessions attended by participants [6 months]
Change in reported diet quality [baseline, 6 months]
measured by comparing baseline and six month survey responses

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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