NCT06574035 Michigan Men's Diabetes Project III(MenDIII): Mind and Motion
| NCT ID | NCT06574035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-01-13 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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!
Contact & Investigator
Jaclynn Hawkins, PhD
PRINCIPAL INVESTIGATOR
University of Michigan, School of Social Work
Frequently Asked Questions
Who can join the NCT06574035 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06574035 currently recruiting?
Yes, NCT06574035 is actively recruiting participants. Contact the research team at jachawk@umich.edu for enrollment information.
Where is the NCT06574035 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06574035 clinical trial?
NCT06574035 is sponsored by University of Michigan. The principal investigator is Jaclynn Hawkins, PhD at University of Michigan, School of Social Work. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.