Michigan Men's Diabetes Project

NCT04760444 | Completed Results

• 2 other identifiers: MenD HUM001909322P30AG024824-16
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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).

  3 months

• 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.

  3 months

Secondary Outcomes (5)

• Body Mass Index (BMI)

  3 months

• Blood Pressure

  3 months

• Depressive Symptom Severity

  3 months

• Diabetes Self-Efficacy

  3 months

• Diabetes Distress

  3 months

Study Arms (2)

Peer Leader Diabetes Self-Management Support (PLDSMS)

EXPERIMENTAL

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.

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

Control Group

ACTIVE COMPARATOR

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

Behavioral: Virtual Diabetes Self-Management Education

Interventions

Peer Leader Diabetes Self-Management Support BEHAVIORAL

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.

Peer Leader Diabetes Self-Management Support (PLDSMS)

Virtual Diabetes Self-Management Education BEHAVIORAL

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.

Control Group; Peer Leader Diabetes Self-Management Support (PLDSMS)

Eligibility Criteria

• Age: 55 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Blue Cross Blue Shield of Michigan Foundation: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 33752609 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Not all participants were able to go to every health assessment and every support session with the Certified Diabetes Care and Education Specialist.

Results Point of Contact

• Title: Dr. Jaclynn Hawkins
• Organization: University of Michigan School of Social Work

jachawk@umich.edu

(734) 647-4072

Study Officials

• Jaclynn Hawkins, MSW, PhD

  University of Michigan, School of Social Work

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 18, 2021
• Study Start: May 15, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)