Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT05370781

Michigan Men's Diabetes Project 2

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
University of Michigan · Academic / Other
Sex
Male
Age
21 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALPeer Led Diabetes Self-Management SupportWhile 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.
BEHAVIORALDiabetes Self-Management EducationParticipants 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.

Timeline

Start date
2022-05-01
Primary completion
2025-12-30
Completion
2026-06-30
First posted
2022-05-12
Last updated
2025-09-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05370781. Inclusion in this directory is not an endorsement.