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NCT04760444 · ClinicalTrials.gov registry record · NA
Michigan Men's Diabetes Project
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT04760444 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 25 participants.
The verdict
NCT04760444, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Peer Leader Diabetes Self-Management Support
- BEHAVIORAL Virtual Diabetes Self-Management Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-05-15 |
| Est. Completion | 2022-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04760444
The ClinicalTrials.gov registry entry for NCT04760444 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Peer Leader Diabetes Self-Management Support is the first listed.
NCT04760444 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04760444 about?
NCT04760444 is a clinical study titled "Michigan Men's Diabetes Project". 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 succ...
What is the current status of trial NCT04760444?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2021-05-15. Estimated completion is 2022-01-31.
What interventions are being tested in trial NCT04760444?
The interventions under investigation include: Peer Leader Diabetes Self-Management Support (BEHAVIORAL), Virtual Diabetes Self-Management Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT04760444?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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