Michigan Men's Diabetes Project III(MenDIII): Mind and Motion
NCT06574035
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) 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.
Eligibility
Inclusion Criteria: * 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 Criteria: * 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!
Conditions4
Locations1 site
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NCT06574035