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

University of Michigan

Status: Enrolling

Conditions: Depressive Symptoms; Depression; Diabetes Mellitus, Type 2

Treatments: Behavioral: Exercise; Behavioral: Group Discussions - Ongoing Support; Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06574035

HUM00256519

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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!

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Behavioral: Group Discussions - Ongoing Support

Behavioral: Exercise

Control Group

Active Comparator group

Description:

Participants randomized to the control group will receive enhanced usual care (EUC). The EUC group will receive 8 sessions of standard Cognitive Behavioral Therapy.

Treatment:

Behavioral: Cognitive Behavioral Therapy