N/A
N=25
Michigan Men's Diabetes Project
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT04760444 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Hemoglobin A1C — -0.20; -0.13 percent of hemoglobin A1c
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peer Leader Diabetes Self-Management Support (Behavioral); Virtual Diabetes Self-Management Education (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Male
- Sponsor
- University of Michigan
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1C |
-0.20; -0.13 | — |
| PRIMARY Self-Care Activities |
1.32; 1.77; 0.27; 0.74; 0.95; 2.02 | — |
| SECONDARY Body Mass Index (BMI) |
-0.31; -0.41 | — |
| SECONDARY Blood Pressure |
-5.23; 10.34; -1.33; 0.15 | — |
| SECONDARY Depressive Symptom Severity |
-0.45; 0.09 | — |
| SECONDARY Diabetes Self-Efficacy |
0.27; 0.33 | — |
| SECONDARY Diabetes Distress |
-3.91; -0.68 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04760444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.