Michigan Men's Diabetes Project 2

Diabetes Mellitus, Type 2 Clinical Trial

— MenD 2  

Official title:

Michigan Men's Diabetes Project 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370781
• Other study ID #: HUM00200469
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: Jaclynn Hawkins, PhD
• Phone: (734) 615-2817
• Email: jachawk[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c	Anthropometric/clinical data	baseline, 3-months, 9-months, 15-months
Primary	Change in Regimen Adherence	Survey data	baseline, 3-months, 9-months, 15-months
Secondary	Change in Depression	survey data	baseline, 3-months, 9-months, 15-months
Secondary	Change in Body Mass Index	Anthropometric data/clinical data	baseline, 3-months, 9-months, 15-months
Secondary	Change in Blood Pressure	Anthropometric data/clinical data	baseline, 3-months, 9-months, 15-months
Secondary	Change in Diabetes Social Support	survey data	baseline, 3-months, 9-months, 15-months
Secondary	Change in Diabetes-Related Distress	survey data	baseline, 3-months, 9-months, 15-months
Secondary	Change in Diabetes Quality of Life	survey data	baseline, 3-months, 9-months, 15-months
Secondary	Change in Adherence to gender norms	survey data	baseline, 3-months, 9-months, 15-months