Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Study acronym: MenDIII
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Final enrollment: 19 participants (planned 80)
    • Primary and study completion dates changed from estimate of Sep 2026 to Aug 28, 2026
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  2. Minor Re-verified, no change to tracked fieldsv9
  3. Notable Primary completion date: Dec 2025 to Sep 2026
    • Study completion date: Jun 2026 to Sep 2026
    • Site contact updated
    v8
  4. Notable Primary endpoints: 5 to 4
    • Eligibility criteria shortened, about 60 words
    • Secondary endpoints: 2 to 1
    • Site contact updated
    v7
  5. Minor Start date changed from estimate of Jan 2025 to Jan 13, 2025v6
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  2. Notable Start date: Nov 2024 to Jan 2025
    • Eligibility criteria expanded, about 17 words
    • Study title shortened, about 2 words
    v4
  3. Notable Start date: Sep 2024 to Nov 2024
    • Site contact updated
    v3
  4. Notable Primary endpoints revised (5)
    • Secondary endpoints revised (2)
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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) 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.
Trial Details
NCT Number NCT06574035
Lead Sponsor University of Michigan
Conditions
(from sponsor)
Diabetes Mellitus, Type 2, Depressive Symptoms, Depression
Related terms Depression, Diabetes Mellitus, Type 2
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov