Michigan Men's Diabetes Project 2
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Diabetes Self-Management EducationBehavioral: Peer Led Diabetes Self-Management Support
- Registration Number
- NCT05370781
- Lead Sponsor
- University of Michigan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 48
- Black/African American males, age 21 years or older with diagnosis of T2D for six months, transportation to attend program activities, under the care of a physician for diabetes, and willing to attend group delivered sessions.
- We considered restricting eligibility to a higher-risk population of participants with A1c ≥ 8%. Preliminary data suggest that over 50% of the proposed study sample will have an A1c ≥ 8%. Focusing on all older Black men with T2D allows us to cast a wide net for secondary prevention and public health impact.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Diabetes Self-Management Education Participants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. Peer led diabetes self-management support (PLDSMS) Peer Led Diabetes Self-Management Support 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. Peer led diabetes self-management support (PLDSMS) Diabetes Self-Management Education 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.
- Primary Outcome Measures
Name Time Method Change in Regimen Adherence baseline, 3-months, 9-months, 15-months Survey data
Change in Hemoglobin A1c baseline, 3-months, 9-months, 15-months Anthropometric/clinical data
- Secondary Outcome Measures
Name Time Method Change in Depression baseline, 3-months, 9-months, 15-months survey data
Change in Body Mass Index baseline, 3-months, 9-months, 15-months Anthropometric data/clinical data
Change in Blood Pressure baseline, 3-months, 9-months, 15-months Anthropometric data/clinical data
Change in Diabetes Social Support baseline, 3-months, 9-months, 15-months survey data
Change in Diabetes-Related Distress baseline, 3-months, 9-months, 15-months survey data
Change in Diabetes Quality of Life baseline, 3-months, 9-months, 15-months survey data
Change in Adherence to gender norms baseline, 3-months, 9-months, 15-months survey data
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States