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The Michigan Men's Diabetes Project 2 (MenD 2) is an 18-month pilot randomized clinical trial. We are looking to recruit 60 Black men with type 2 diabetes (need to have diagnosis for at least 6 months) that are over the age of 21. Interested participants need to be under the care of a physician for their diabetes, have access to reliable transportation for study activities, and be willing to participate in 4 health assessments where they will get their A1C, blood pressure, height, and weight measured and they will complete a survey. All participants will receive 10 hours of diabetes self-management education with a Certified Diabetes Care and Education Specialist. Participants randomized to the intervention arm will also be offered 6 months of monthly diabetes self-management support (DSMS) sessions with trained Peer Leaders who are also Black men with type 2 diabetes. After the 6 months of support, this group will transition into 6 months of ongoing support where they can continue DSMS and/or other diabetes related initiatives that are important to the group and chosen by the group. Due to the COVID-19 pandemic, DSME and DSMS sessions will likely be held via Zoom, ongoing support sessions have potential to be in person. The 4 health assessments will take place at baseline, 3-months, 9-months, and 15-months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer led diabetes self-management support (PLDSMS) | Experimental | Participants in the PLDSMS arm will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. This group will then transition into monthly 90-minute diabetes self-management support (DSMS) with trained peer leaders for 6 months. After the DSMS sessions, the group will transition into 6 months of ongoing support and will be encouraged to continue DSMS through initiatives that are important to them. |
|
| Control Group | Active Comparator | Participants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Led Diabetes Self-Management Support | Behavioral | While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Anthropometric/clinical data | baseline, 3-months, 9-months, 15-months |
| Change in Regimen Adherence | Survey data | baseline, 3-months, 9-months, 15-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression | survey data | baseline, 3-months, 9-months, 15-months |
| Change in Body Mass Index | Anthropometric data/clinical data |
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Inclusion Criteria:
Exclusion Criteria:
Self-representation of gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Jaclynn Hawkins, PhD | University of Michigan, School of Social Work | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36862648 | Derived | Hawkins J, Sengupta S, Kloss K, Kurnick K, Ewen A, Nwawkwo R, Funnell M, Mitchell J, Jones L, Piatt G. Michigan men's diabetes project II: Protocol for peer-led diabetes self-management education and long-term support in Black men. PLoS One. 2023 Mar 2;18(3):e0277733. doi: 10.1371/journal.pone.0277733. eCollection 2023. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 18, 2026 | |
| Reset | Jun 15, 2026 |
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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: Participant Consent Form | Oct 4, 2022 | Oct 19, 2023 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Peer Leader Consent Form | Oct 4, 2022 | Oct 19, 2023 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2026 | Jun 15, 2026 | |||
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Diabetes Self-Management Education | Behavioral | Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom platform. |
|
| baseline, 3-months, 9-months, 15-months |
| Change in Blood Pressure | Anthropometric data/clinical data | baseline, 3-months, 9-months, 15-months |
| Change in Diabetes Social Support | survey data | baseline, 3-months, 9-months, 15-months |
| Change in Diabetes-Related Distress | survey data | baseline, 3-months, 9-months, 15-months |
| Change in Diabetes Quality of Life | survey data | baseline, 3-months, 9-months, 15-months |
| Change in Adherence to gender norms | survey data | baseline, 3-months, 9-months, 15-months |
| D004700 | Endocrine System Diseases |