Status:
RECRUITING
Michigan Men's Diabetes Project III(MenDIII): Mind and Motion
Lead Sponsor:
University of Michigan
Conditions:
Diabetes Mellitus, Type 2
Depressive Symptoms
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 di...
Eligibility Criteria
Inclusion
- 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
Exclusion
- stage 2 hypertension as defined by Joint National Committee (JNC) VIII
- recent cardiac events
- recent laser surgery for proliferative retinopathy
- history of stroke
- lower limb amputation
- peripheral neuropathy
- severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)
- class III or IV heart failure
- medical instability.
- Per American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing:
- ongoing unstable angina
- uncontrolled cardiac arrhythmia with hemodynamic compromise
- active endocarditis
- symptomatic severe aortic stenosis
- acute myocarditis or pericarditis
- acute aortic dissection
- acute pulmonary embolism
- pulmonary infarction
- deep venous thrombosis
- physical disability that precludes safe and adequate testing
- chest discomfort with exertion
- 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!
Key Trial Info
Start Date :
January 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06574035
Start Date
January 13 2025
End Date
June 1 2026
Last Update
March 24 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109