MenD 2: Michigan Men's Diabetes Project 2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Peer led diabetes self-management support (PLDSMS) 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
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.
|
| Active Comparator: Control Group 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
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.
|
Outcome Measures
Primary Outcome Measures
- Change in Hemoglobin A1c [baseline, 3-months, 9-months, 15-months]
Anthropometric/clinical data
- Change in Regimen Adherence [baseline, 3-months, 9-months, 15-months]
Survey data
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Jaclynn Hawkins, PhD, University of Michigan, School of Social Work
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00200469