RecruitingNot ApplicableNCT06574035

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion


Sponsor

University of Michigan

Enrollment

80 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is designed specifically for African American men with type 2 diabetes living in Michigan. It combines physical activity, exercise, and cognitive behavioral therapy (CBT) to help manage diabetes and improve mental health simultaneously. **You may be eligible if...** - You identify as African American or Black male - You are 18 years or older - You can walk independently - You have had type 2 diabetes for at least 1 year and are under a doctor's care - Your most recent HbA1c (blood sugar average) is 7.0% or higher - You live in Wayne or Washtenaw County, Michigan - You have reliable internet access and transportation to in-person events **You may NOT be eligible if...** - You have Stage 2 high blood pressure (uncontrolled) - You have had a recent heart event or procedure - You are unable to commit to weekly program activities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive Behavioral Therapy

Cognitive behavioral therapy focuses on the unique needs of men. A culturally adapted CBT program will be administered to participants as it has demonstrated increased effectiveness for marginalized populations. Cognitive Behavioral Therapy (CBT) aligns well with these cultural needs due to its individualized approach, non-judgmental stance, collaborative nature, and emphasis on empowerment through skills building.

BEHAVIORALExercise

Research demonstrates a preference for physical activity interventions among men with chronic illnesses, while highlighting limited access to fitness facilities in low-income urban areas as a barrier to participation. Online physical activity interventions have shown efficacy and cost-effectiveness in improving health behaviors, with virtual exercise programs for low-income African American populations demonstrating significant reductions in depressive symptoms. Therefore participants will receive exercise to help improve their diabetes self-management behaviors and depressive symptoms.

BEHAVIORALGroup Discussions - Ongoing Support

Participants will join group discussions that will serve as on-going support. The small group component is designed to foster self-efficacy, autonomous motivation, and enjoyment by integrating skills building, personal values, spirituality, and goal setting. This approach has shown positive outcomes in previous pilot studies with African American men, serving as a source of vicarious learning and social support.


Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

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