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NCT Number: NCT06574035

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

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.

Recruiting

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Behavioral Symptoms Depression Depressive Symptoms Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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!

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. Change in A1C

    Time frame: Screening, Baseline, 10 weeks, 18 weeks, 30 weeks

    Anthropometric/clinical data

  2. Change in General Quality of Life (12-Item Short Form Survey (SF-12))

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Survey Data - 12 questions covering physical and mental health domains - Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.

  3. Change in Diabetes-Related Distress (The Type 2 Diabetes Distress Assessment System)

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Survey Data - The assessment system has two components: The Core Distress Scale and The Sources Scale. The CORE DISTRESS SCORE is simply the average of the 8 items of the CORE SCALE, with each item rated on a 1 to 5 scale: Mean score < 2.0 indicate little or no distress, Mean score between 2.0 and 2.9 indicate moderate distress, Mean score > 3.0 indicate high distress. The Sources scale aims to find the sources of the distress, whether CORE DISTRESS is high or low, it is helpful to identify those aspects of living with diabetes that are contributing to the individual's diabetes distress.

  4. Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument)

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Survey Data - Survey answers range for each section of the survey asking about satisfaction, worry, and impact of diabetes. The DQoL measure consists of 46 items ranked on a 5-point Likert scale. Individual domain and DQoL total scores range from 0 (lowest possible QoL) to 100 (highest possible QoL).

Secondary outcomes

  1. Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale)

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Survey Data - The scale is an 8-item scale that uses a 5-point Likert scale to measure self-efficacy in diabetes management. The scale ranges from 8 to 40 points, with higher scores indicating greater self-efficacy.

Other outcomes

  1. Change in Masculinity Ideology (The Conformity to Masculine Norms Inventory-30)

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Survey Data - The CMNI-30's subscales are scored by adding up the scores of each item. It is a 30-item scale that measures how much a person conforms to masculine norms in US society. The items are rated on a six-point Likert scale, ranging from 0 (strongly disagree) to 5 (strongly agree), with nine items reverse-coded.

  2. Change in BMI

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Anthropometric/clinical data

  3. Chance in Estimated Abdominal Subcutaneous and Visceral Fat Stores

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Anthropometric/clinical data

  4. Change in Diabetes Social Support (Duke/UNC Functional Social Support)

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Survey Data - Responses are scaled on a 1-5 scale and tallied to create a total score with higher values indicating greater social support.

  5. Sociodemographic characteristics

    Time frame: Baseline

    Survey Data

  6. Healthcare utilization

    Time frame: Baseline

    Survey Data

  7. Comorbidities

    Time frame: Baseline

    Survey Data

  8. Change in Medication Adherence (Adherence to Refills and Medicines Scale for Diabetes)

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Survey Data - The scale a 14-question survey that measures self-reported medication adherence. The ARMS-D is designed to be brief and easy to use, and can help identify reasons for non-adherence. Each item on the scale is rated on a four-point Likert scale, with 1 being "none of the time" and 4 being "all of the time". The items are then summed to create a score that ranges from 11 to 44, with higher scores indicating better adherence.

  9. Change in Aerobic Capacity (6 minute walk test)

    Time frame: Baseline, 10 weeks, 30 weeks

    Anthropometric/clinical data

  10. Change in Working Alliance between Counselor & Participant (Working Alliance Inventory - Short Revised)

    Time frame: Up to 8 weeks

    Survey Data - The Scale is 12 questions, Each item is scored from 1-7, minimum=1 to maximum=7, ranging from Never to Always. Higher scores reflect a more positive rating of working alliance.

  11. Change in Metabolic Control (continuous blood glucose levels)

    Time frame: Up to 18 weeks

    Anthropometric/clinical data

  12. Change in Depression Symptoms (Patient Health Questionnaire 9)

    Time frame: Screening and throughout study completion, up to 30 weeks.

    Survey Data - Answer Options rang from Not at all = 0, Several days = 1, More than half the days = 2, Nearly every day = 3. Scores can range from 1 - 27, the higher the score, the more severe the depression.

  13. Change in Blood Pressure (systolic and diastolic)

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Anthropometric/clinical data

  14. Change in Physical Activity Regimen

    Time frame: Up to 18 weeks

    Exercise Log Data

  15. Change in Heart Rate

    Time frame: Baseline, 10 weeks, 18 weeks, 30 weeks

    Anthropometric/clinical data

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Burgess, MPH

CONTACT

[email protected]

(734)-210-1756

Jaclynn Hawkins, PhD

CONTACT

[email protected]

(734) 615-2817

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: MenDIII

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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