Trials / Active Not Recruiting
Active Not RecruitingNCT05370781
Michigan Men's Diabetes Project 2
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- Male
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Peer Led Diabetes Self-Management Support | 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. |
| BEHAVIORAL | Diabetes Self-Management Education | 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. |
Timeline
- Start date
- 2022-05-01
- Primary completion
- 2025-12-30
- Completion
- 2026-06-30
- First posted
- 2022-05-12
- Last updated
- 2025-09-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05370781. Inclusion in this directory is not an endorsement.