Michigan Men's Diabetes Project III(MenDIII): Mind and Motion
Purpose
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.
Conditions
- Diabetes Mellitus, Type 2
- Depressive Symptoms
- Depression
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
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!
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Intervention Group |
Participants randomized to the intervention group will receive 8 one hour virtual sessions of individual cognitive behavioral therapy (CBT) that will take place via U-M Zoom, which is a HIPAA compliant virtual conferencing platform. Participants in this group will also receive 8 one hour virtual sessions of individual exercise. Participants in this group will also receive 8 one hour virtual group discussion sessions that will serve as on-going support. This group (4-8 participants) discussion will be facilitated by one CBT Interventionist and one Exercise Interventionist. These sessions will take place following the individual sessions of CBT and Exercise. |
|
Active Comparator Control Group |
Participants randomized to the control group will receive enhanced usual care (EUC). The EUC group will receive 8 sessions of standard Cognitive Behavioral Therapy. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Michigan