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Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion

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Contents

clinicaltrials.gov/study/NCT06574035
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT065740350
Health Conditions in Trial
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Depression
0
Trial Recruitment Size
800
Trial Sponsor
University of Michigan
University of Michigan
0
Clinical Trial Start Date
2024
0
Primary Completion Date
2025
0
Study Completion Date
2026
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Health Services Research0
Intervention Type
Behavioral0
Interventional Trial Phase
Not Applicable0
Participating Facility
University of Michigan
University of Michigan
0
Official Name
Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion0
Last Updated
August 27, 2024
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Exercise0
Group Discussions - Ongoing Support0
Cognitive Behavioral Therapy0
Study summary

The Michigan Men's Diabetes Project III: Mind \& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) and with depression (Patient Health Questionnaire - 9 score over 5) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours/sessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.

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