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NCT06574035Completed

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

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
19 (actual)
First submitted
21 Aug 2024
Start date
Jan 2025
Primary completion date
Aug 2026
Lead sponsor
University of Michigan
NCT number
NCT06574035

What you commit to

  • Study type: Interventional
  • Participants enrolled: 19
  • From Jan 2025 to the primary completion date, Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • recent laser surgery for proliferative retinopathy
  • unreasonable breathlessness, or dizziness, fainting, or blackouts.
    • As part of the screening process, the investigators will ask the participant to self-report on these conditions. Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health provider will be excluded. Participants who are currently receiving only medication management from a psychiatrist will be included.
    • If you are interested in the study, please complete our screening survey: https://redcapproduction.umms.med.umich.edu/surveys/?s=JNPPEDANX7KLPPF9. Thank you so much!

Other illness

  • stage 2 hypertension as defined by Joint National Committee (JNC) VIII
  • recent cardiac events
  • history of stroke
  • severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)
  • class III or IV heart failure
  • ongoing unstable angina
  • uncontrolled cardiac arrhythmia with hemodynamic compromise
  • deep venous thrombosis

Other

  • lower limb amputation
  • peripheral neuropathy
  • medical instability.
    • Per American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing:
  • active endocarditis
  • symptomatic severe aortic stenosis
  • acute myocarditis or pericarditis
  • acute aortic dissection
  • acute pulmonary embolism
  • pulmonary infarction
  • physical disability that precludes safe and adequate testing
  • chest discomfort with exertion

Who the study is looking for

  • African American/Black males
  • age 18 years or older
  • ambulatory status
  • diagnosis of Type 2 Diabetes (T2D) for one year duration or longer
  • be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year
  • be willing to participate in study events (weekly physical activity, exercise and 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\\
  • have reliable transportation to in-person events

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.