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The Inspiring Action to Prevent Diabetes Intervention

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06001801
Acronym
INSPIRA
Enrollment
142
Registered
2023-08-21
Start date
2023-09-18
Completion date
2025-12-31
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PreDiabetes

Keywords

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

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.

Interventions

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.

BEHAVIORALINSPIRA

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.

Sponsors

American Diabetes Association
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of group sessions attended by participants6 monthsThis count will be out of 16 possible weekly group sessions.

Secondary

MeasureTime frameDescription
Change in weightbaseline, 6 monthsWeight will be measured in pounds to the nearest tenth.
Change in hemoglobin A1cbaseline, 6 months
Change in waist circumferencebaseline, 6 monthsThis will be measured in centimeters.
Change in reported diet qualitybaseline, 6 monthsmeasured by comparing baseline and six month survey responses

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026