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Michigan Men's Diabetes Project 2 (MenD 2)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Led Diabetes Self-Management Support
Diabetes Self-Management Education
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peer led diabetes self-management support (PLDSMS)

Control Group

Arm Description

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.

Participants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist.

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c
Anthropometric/clinical data
Change in Regimen Adherence
Survey data

Secondary Outcome Measures

Change in Depression
survey data
Change in Body Mass Index
Anthropometric data/clinical data
Change in Blood Pressure
Anthropometric data/clinical data
Change in Diabetes Social Support
survey data
Change in Diabetes-Related Distress
survey data
Change in Diabetes Quality of Life
survey data
Change in Adherence to gender norms
survey data

Full Information

First Posted
May 3, 2022
Last Updated
October 19, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05370781
Brief Title
Michigan Men's Diabetes Project 2
Acronym
MenD 2
Official Title
Michigan Men's Diabetes Project 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer led diabetes self-management support (PLDSMS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Intervention Type
Behavioral
Intervention Name(s)
Peer Led Diabetes Self-Management Support
Intervention Description
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
Intervention Name(s)
Diabetes Self-Management Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c
Description
Anthropometric/clinical data
Time Frame
baseline, 3-months, 9-months, 15-months
Title
Change in Regimen Adherence
Description
Survey data
Time Frame
baseline, 3-months, 9-months, 15-months
Secondary Outcome Measure Information:
Title
Change in Depression
Description
survey data
Time Frame
baseline, 3-months, 9-months, 15-months
Title
Change in Body Mass Index
Description
Anthropometric data/clinical data
Time Frame
baseline, 3-months, 9-months, 15-months
Title
Change in Blood Pressure
Description
Anthropometric data/clinical data
Time Frame
baseline, 3-months, 9-months, 15-months
Title
Change in Diabetes Social Support
Description
survey data
Time Frame
baseline, 3-months, 9-months, 15-months
Title
Change in Diabetes-Related Distress
Description
survey data
Time Frame
baseline, 3-months, 9-months, 15-months
Title
Change in Diabetes Quality of Life
Description
survey data
Time Frame
baseline, 3-months, 9-months, 15-months
Title
Change in Adherence to gender norms
Description
survey data
Time Frame
baseline, 3-months, 9-months, 15-months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-representation of gender identity
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaclynn Hawkins, PhD
Phone
(734) 615-2817
Email
jachawk@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaclynn Hawkins, PhD
Organizational Affiliation
University of Michigan, School of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaclynn Hawkins, PhD

12. IPD Sharing Statement

Learn more about this trial

Michigan Men's Diabetes Project 2

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