Clinical trial NCT05370781: Michigan Men's Diabetes Project 2
Official title: Michigan Men's Diabetes Project 2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 48
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: baseline, 3-months, 9-months, 15-months
measure: Change in Regimen Adherence
timeFrame: baseline, 3-months, 9-months, 15-months
Secondary outcomes:
measure: Change in Depression
timeFrame: baseline, 3-months, 9-months, 15-months
measure: Change in Body Mass Index
timeFrame: baseline, 3-months, 9-months, 15-months
measure: Change in Blood Pressure
timeFrame: baseline, 3-months, 9-months, 15-months
measure: Change in Diabetes Social Support
timeFrame: baseline, 3-months, 9-months, 15-months
measure: Change in Diabetes-Related Distress
timeFrame: baseline, 3-months, 9-months, 15-months
measure: Change in Diabetes Quality of Life
timeFrame: baseline, 3-months, 9-months, 15-months
measure: Change in Adherence to gender norms
timeFrame: baseline, 3-months, 9-months, 15-months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan, School of Social Work
name: Jaclynn Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: