Michigan Men's Diabetes Project 2

NCT05370781 | Active Not Recruiting DMC

• 1 other identifier: HUM00200469
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in Depression

  baseline, 3-months, 9-months, 15-months

• Change in Body Mass Index

  baseline, 3-months, 9-months, 15-months

• Change in Blood Pressure

  baseline, 3-months, 9-months, 15-months

• Change in Diabetes Social Support

  baseline, 3-months, 9-months, 15-months

• Change in Diabetes-Related Distress

  baseline, 3-months, 9-months, 15-months

Study Arms (2)

Peer led diabetes self-management support (PLDSMS)

EXPERIMENTAL

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; Behavioral: Diabetes Self-Management Education

Control Group

ACTIVE COMPARATOR

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

Interventions

Peer Led Diabetes Self-Management Support 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.

Peer led diabetes self-management support (PLDSMS)

Diabetes Self-Management Education 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; Peer led diabetes self-management support (PLDSMS)

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 36862648 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jaclynn Hawkins, PhD

  University of Michigan, School of Social Work

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 12, 2022
• Study Start: May 1, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

US (1)