Recruiting

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

Sponsor:

University of Michigan

Code:

NCT06574035

Conditions

Diabetes Mellitus, Type 2

Depressive Symptoms

Depression

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy

Exercise

Group Discussions - Ongoing Support

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

Depressive Symptoms

Depression

Study ID

NCT06574035

Start date

Jan 13, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

Cognitive 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.

Exercise

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.

Group 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.

Primary outcome measure

Change in A1C [ Time Frame: Screening, Baseline, 10 weeks, 18 weeks, 30 weeks ]
Change in General Quality of Life (12-Item Short Form Survey (SF-12)) [ Time Frame: Baseline, 10 weeks, 18 weeks, 30 weeks ]
Change in Diabetes-Related Distress (The Type 2 Diabetes Distress Assessment System) [ Time Frame: Baseline, 10 weeks, 18 weeks, 30 weeks ]
Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument) [ Time Frame: Baseline, 10 weeks, 18 weeks, 30 weeks ]

Central Contacts and Locations

Central contacts

Jaclynn Hawkins, PhD

(734) 615-2817 jachawk@umich.edu

Hannah Burgess, MPH

(734)-210-1756 hlburges@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jaclynn Hawkins, PhD

(734) 615-2817 jachawk@umich.edu

Hannah Burgess, MPH

(734)-210-1756 hlburges@umich.ed

More Information

Sponsor

University of Michigan

Last update posted

Jun 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-12.