Clinical trial NCT06574035: Michigan Men's Diabetes Project III(MenDIII): Mind and Motion
Official title: Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Depressive Symptoms
Depression
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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!

Primary outcomes:
measure: Change in A1C
timeFrame: Screening, Baseline, 10 weeks, 18 weeks, 30 weeks
measure: Change in General Quality of Life (12-Item Short Form Survey (SF-12))
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
measure: Change in Diabetes-Related Distress (The Type 2 Diabetes Distress Assessment System)
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
measure: Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument)
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
Secondary outcomes:
measure: Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale)
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
Other outcomes:
measure: Change in Masculinity Ideology (The Conformity to Masculine Norms Inventory-30)
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
measure: Change in BMI
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
measure: Chance in Estimated Abdominal Subcutaneous and Visceral Fat Stores
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
measure: Change in Diabetes Social Support (Duke/UNC Functional Social Support)
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
measure: Sociodemographic characteristics
timeFrame: Baseline
measure: Healthcare utilization
timeFrame: Baseline
measure: Comorbidities
timeFrame: Baseline
measure: Change in Medication Adherence (Adherence to Refills and Medicines Scale for Diabetes)
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
measure: Change in Aerobic Capacity (6 minute walk test)
timeFrame: Baseline, 10 weeks, 30 weeks
measure: Change in Working Alliance between Counselor & Participant (Working Alliance Inventory - Short Revised)
timeFrame: Up to 8 weeks
measure: Change in Metabolic Control (continuous blood glucose levels)
timeFrame: Up to 18 weeks
measure: Change in Depression Symptoms (Patient Health Questionnaire 9)
timeFrame: Screening and throughout study completion, up to 30 weeks.
measure: Change in Blood Pressure (systolic and diastolic)
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
measure: Change in Physical Activity Regimen
timeFrame: Up to 18 weeks
measure: Change in Heart Rate
timeFrame: Baseline, 10 weeks, 18 weeks, 30 weeks
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan, School of Social Work
name: Jaclynn Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: