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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Prevention Program (DPP) (usual care) | Active Comparator |
| |
| DPP plus the INSPIRA intervention | Experimental | This arm will include the DPP plus additional interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of group sessions attended by participants | This count will be out of 16 possible weekly group sessions. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Weight will be measured in pounds to the nearest tenth. | baseline, 6 months |
| Change in hemoglobin A1c | baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Ellen M Heisler, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health and Social Services Center, Incorporated | Detroit | Michigan | 48209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40456483 | Derived | Heisler M, Quiroga G, Valbuena F, Resnicow K, Stoll S, Griauzde DH, Hofer T, Kullgren JT. INSPIRing Action to Prevent Diabetes (INSPIRA): Rationale and description of a pilot intervention combining peer support and food voucher incentives to increase engagement in a community health worker-led diabetes prevention program. Contemp Clin Trials. 2025 Aug;155:107971. doi: 10.1016/j.cct.2025.107971. Epub 2025 May 31. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2023 | Nov 19, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D001519 | Behavior |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| Change in waist circumference | This will be measured in centimeters. | baseline, 6 months |
| Change in reported diet quality | measured by comparing baseline and six month survey responses | baseline, 6 months |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |