Michigan Men's Diabetes Project

University of Michigan

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Virtual Diabetes Self-Management Education; Behavioral: Peer Leader Diabetes Self-Management Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04760444

2P30AG024824-16 (U.S. NIH Grant/Contract)

MenD HUM00190932

Details and patient eligibility

About

The investigators propose to develop a training for male peer leaders facilitating diabetes self-management education and support (DSMES) to specifically encourage conversations regarding beliefs that affect men's health and to allow modeling of alternative views and perspectives that allow for successful disease management to be framed as competence and strength. Given that the life expectancy for Black men in the US is 71, the investigators hypothesize that targeting men in earlier stages of type 2 diabetes (T2D) will assist greatly in facilitating healthy aging and improving diabetes-related health outcomes later in life.

Based on the investigators previous work, the long-term goal of our research is to determine the most effective, practical, and sustainable approach to provide DSMES to older Black men. The objective is to examine the relative effectiveness, feasibility, and acceptability of a peer-leader DSMES intervention for Black men with T2D. To accomplish this, the investigators will engage in a developmental phase and a validation phase [pilot randomized control trial (RCT)]. The RCT will be conducted with 60 Black adult male residents of metro Detroit, Michigan. Participants will be randomized to a control group or the tailored peer-leader diabetes self-management support group (PLDSMS). All participants will receive DSME with a certified diabetes care and education specialists. Only participants randomized to the PLDSMS group will also receive an additional 6 weeks of DSMS led by the peer leaders. The investigators hypothesize that 1) participants in the PLDSMS group will have improved outcomes (A1c, blood pressure, weight, diabetes distress, self-management behaviors, etc.) over the control group, and 2) an evaluation of measures will confirm efficacy of the PLDSMS.

Enrollment: 25 patients

Sex: Male

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• Age 55 or older
• Black/African American
• Diagnosis of type 2 diabetes for a six-month duration or longer.

Exclusion criteria

• Non-ambulatory
• Serious health conditions (morbid obesity and severe symptomatic heart disease, visual impairment, renal failure, and peripheral neuropathy)
• Psychiatric illness (severity requiring hospitalization)
• Cognitive deficit
• Serious diabetes complications (e.g. blindness) that would impede meaningful participation.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Peer Leader Diabetes Self-Management Support (PLDSMS)

Experimental group

Description:

Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.

Treatment:

Behavioral: Virtual Diabetes Self-Management Education

Behavioral: Peer Leader Diabetes Self-Management Support

Control Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Virtual Diabetes Self-Management Education