Michigan Men's Diabetes Project 2

NCT ID: NCT05370781

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2026-06-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Peer Led Diabetes Self-Management Support

Intervention Type: 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.

Diabetes Self-Management Education

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Diabetes Self-Management Education

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jaclynn Hawkins

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaclynn Hawkins, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, School of Social Work

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36862648 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form: Participant Consent Form

View Document

Document Type: Informed Consent Form: Peer Leader Consent Form

View Document

Other Identifiers

HUM00200469

Identifier Type: -

Identifier Source: org_study_id