Michigan Men's Diabetes Project
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Leader Diabetes Self-Management Support
Virtual Diabetes Self-Management Education
Sponsored by

About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2
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.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peer Leader Diabetes Self-Management Support (PLDSMS)
Control Group
Arm 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.
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Outcomes
Primary Outcome Measures
Hemoglobin A1C
This outcome measure is change in hemoglobin A1C measured using the DCA 2000 point-of-care testing instrument (value at 3 months minus value at baseline).
Self-Care Activities
This outcome measure is change in self-care activities as measured by the Summary of Diabetes Self-Care Activities (SDSCA) scale (value at 3 months minus value at baseline). The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. The range for the general diet, specific diet, exercise, blood-glucose testing, and foot care sub scales included below is 0 to 7. Higher scores are indicative of more frequent self-care activities compared to lower scores.
Secondary Outcome Measures
Body Mass Index (BMI)
This outcome measure is change in BMI (value at 3 months minus value at baseline). BMI was calculated using height and weight. Height was measured using a stadiometer. Weight was measured on a high quality, calibrated digital scale. The BMI categories are: Underweight = <18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater.
Blood Pressure
The outcome measure is the change in blood pressure (value at 3 months minus value at baseline). Blood pressure was measured using the auscultatory method.
Depressive Symptom Severity
This outcome measure is change in depressive symptom severity as measured by the Patient Health Questionnaire-2 (PHQ-2) Scale (value at 3 months minus value at baseline). Scores range from 0 to 6. Higher scores are indicative of more depressive symptoms.
Diabetes Self-Efficacy
This outcome measure is change in diabetes self-efficacy as measured by the 8-item Diabetes Self-Efficacy Scale (DSES) (value at 3 months minus value at baseline). The scores for this scale range from 1 to 10. Higher scores are indicative of higher self-efficacy.
Diabetes Distress
This outcome measure is change in diabetes distress as measured by the 17-item Diabetes Distress Scale (DDS17) (value at 3 months minus value at baseline). Scores for the DDS17 range from 1 to 6. Higher scores are indicate higher diabetes distress. A score of 2 - 2.9 is considered 'moderate distress,' and a score greater than 3.0 is considered 'high distress.'
Full Information
NCT ID
NCT04760444
First Posted
February 2, 2021
Last Updated
May 25, 2023
Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation, National Institutes of Health (NIH), National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04760444
Brief Title
Michigan Men's Diabetes Project
Official Title
Michigan Men's Diabetes Project (MenD) - Peer Leader Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Blue Cross Blue Shield of Michigan Foundation, National Institutes of Health (NIH), National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer Leader Diabetes Self-Management Support (PLDSMS)
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Leader 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)
Virtual 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, Med platform.
Primary Outcome Measure Information:
Title
Hemoglobin A1C
Description
This outcome measure is change in hemoglobin A1C measured using the DCA 2000 point-of-care testing instrument (value at 3 months minus value at baseline).
Time Frame
3 months
Title
Self-Care Activities
Description
This outcome measure is change in self-care activities as measured by the Summary of Diabetes Self-Care Activities (SDSCA) scale (value at 3 months minus value at baseline). The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. The range for the general diet, specific diet, exercise, blood-glucose testing, and foot care sub scales included below is 0 to 7. Higher scores are indicative of more frequent self-care activities compared to lower scores.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
This outcome measure is change in BMI (value at 3 months minus value at baseline). BMI was calculated using height and weight. Height was measured using a stadiometer. Weight was measured on a high quality, calibrated digital scale. The BMI categories are: Underweight = <18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater.
Time Frame
3 months
Title
Blood Pressure
Description
The outcome measure is the change in blood pressure (value at 3 months minus value at baseline). Blood pressure was measured using the auscultatory method.
Time Frame
3 months
Title
Depressive Symptom Severity
Description
This outcome measure is change in depressive symptom severity as measured by the Patient Health Questionnaire-2 (PHQ-2) Scale (value at 3 months minus value at baseline). Scores range from 0 to 6. Higher scores are indicative of more depressive symptoms.
Time Frame
3 months
Title
Diabetes Self-Efficacy
Description
This outcome measure is change in diabetes self-efficacy as measured by the 8-item Diabetes Self-Efficacy Scale (DSES) (value at 3 months minus value at baseline). The scores for this scale range from 1 to 10. Higher scores are indicative of higher self-efficacy.
Time Frame
3 months
Title
Diabetes Distress
Description
This outcome measure is change in diabetes distress as measured by the 17-item Diabetes Distress Scale (DDS17) (value at 3 months minus value at baseline). Scores for the DDS17 range from 1 to 6. Higher scores are indicate higher diabetes distress. A score of 2 - 2.9 is considered 'moderate distress,' and a score greater than 3.0 is considered 'high distress.'
Time Frame
3 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaclynn Hawkins, MSW, 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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33752609
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.
Results Reference
derived
Learn more about this trial
Michigan Men's Diabetes Project
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