Michigan Men's Diabetes Project III(MenDIII): Mind and Motion
Recruiting · NCT06574035 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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!
Where it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States