Michigan Men's Diabetes Project 2

Study Overview
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Brief Summary
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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.

Official Title
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Michigan Men's Diabetes Project 2

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Peer Led Diabetes Self-Management Support
* Behavioral: Diabetes Self-Management Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer led diabetes self-management support (PLDSMS)<br>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. | Behavioral: Peer Led Diabetes Self-Management Support<br>* 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.<br>Behavioral: Diabetes Self-Management Education<br>* 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.<br>|
| Active Comparator: Control Group<br>Participants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. | Behavioral: Diabetes Self-Management Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |