Clinical trial NCT04760444: Michigan Men's Diabetes Project
Official title: Michigan Men's Diabetes Project (MenD) - Peer Leader Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2021-02-18
Enrollment: 25
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: 3 months
measure: Self-Care Activities
timeFrame: 3 months
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 3 months
measure: Blood Pressure
timeFrame: 3 months
measure: Depressive Symptom Severity
timeFrame: 3 months
measure: Diabetes Self-Efficacy
timeFrame: 3 months
measure: Diabetes Distress
timeFrame: 3 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, MSW, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hawkins J, Kloss K, Funnell M, Nwankwo R, Schwenzer C, Smith F, Piatt G. Michigan Men's diabetes project (MenD): protocol for a peer leader diabetes self-management education and support intervention. BMC Public Health. 2021 Mar 22;21(1):562. doi: 10.1186/s12889-021-10613-2.