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

NCT06574035 | Recruiting DMC

• 1 other identifier: HUM00256519
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change in A1C

  Anthropometric/clinical data

  Screening, Baseline, 10 weeks, 18 weeks, 30 weeks

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

  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.

  Baseline, 10 weeks, 18 weeks, 30 weeks

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

  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.

  Baseline, 10 weeks, 18 weeks, 30 weeks

• Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument)

  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).

  Baseline, 10 weeks, 18 weeks, 30 weeks

Secondary Outcomes (1)

• Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale)

  Baseline, 10 weeks, 18 weeks, 30 weeks

Other Outcomes (15)

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

  Baseline, 10 weeks, 18 weeks, 30 weeks

• Change in BMI

  Baseline, 10 weeks, 18 weeks, 30 weeks

• Chance in Estimated Abdominal Subcutaneous and Visceral Fat Stores

  Baseline, 10 weeks, 18 weeks, 30 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

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

Control Group

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy

Interventions

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.

Control Group; Intervention Group

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.

Intervention Group

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• ongoing unstable angina
• uncontrolled cardiac arrhythmia with hemodynamic compromise
• active endocarditis
• symptomatic severe aortic stenosis
• acute myocarditis or pericarditis
• acute aortic dissection

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression

Interventions

Cognitive Behavioral Therapy; Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jaclynn Hawkins, PhD

  University of Michigan, School of Social Work

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaclynn Hawkins, PhD

CONTACT

(734) 615-2817; jachawk@umich.edu

Hannah Burgess, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 27, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-03

Locations

US (1)