Michigan Men's Diabetes Project

NCT ID: NCT04760444

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2022-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Peer Leader Diabetes Self-Management Support (PLDSMS)

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.

Group Type: EXPERIMENTAL

Peer Leader Diabetes Self-Management Support

Intervention Type: 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.

Virtual Diabetes Self-Management Education

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Virtual Diabetes Self-Management Education

Intervention Type: 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.

Interventions

Peer Leader Diabetes Self-Management Support

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

Virtual Diabetes Self-Management Education

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Blue Cross Blue Shield of Michigan Foundation

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jaclynn Hawkins

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaclynn Hawkins, MSW, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, School of Social Work

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33752609 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2P30AG024824-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MenD HUM00190932

Identifier Type: -

Identifier Source: org_study_id