Michigan Men's Diabetes Project III(MenDIII): Mind and Motion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Michigan
About this trial
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
This trial does not accept healthy volunteersQualifiers
African American/Black males
age 18 years or older
ambulatory status
diagnosis of Type 2 Diabetes (T2D) for one year duration or longer
Disqualifiers
stage 2 hypertension as defined by Joint National Committee (JNC) VIII
recent cardiac events
recent laser surgery for proliferative retinopathy
history of stroke
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy
BehavioralCognitive 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
BehavioralResearch 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
BehavioralParticipants 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 3 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in A1C
Anthropometric/clinical data
Time frame
Screening, Baseline, 10 weeks, 18 weeks, 30 weeks2
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.
Time frame
Baseline, 10 weeks, 18 weeks, 30 weeks3
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.
Time frame
Baseline, 10 weeks, 18 weeks, 30 weeks4
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).
Time frame
Baseline, 10 weeks, 18 weeks, 30 weeksSecondary outcomes
1
Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale)
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.
Time frame
Baseline, 10 weeks, 18 weeks, 30 weeksOther outcomes
1
Change in Masculinity Ideology (The Conformity to Masculine Norms Inventory-30)
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.
Time frame
Baseline, 10 weeks, 18 weeks, 30 weeks2
Change in BMI
Anthropometric/clinical data
Time frame
Baseline, 10 weeks, 18 weeks, 30 weeks3
Chance in Estimated Abdominal Subcutaneous and Visceral Fat Stores
Anthropometric/clinical data
Time frame
Baseline, 10 weeks, 18 weeks, 30 weeks4
Change in Diabetes Social Support (Duke/UNC Functional Social Support)
Survey Data - Responses are scaled on a 1-5 scale and tallied to create a total score with higher values indicating greater social support.
Time frame
Baseline, 10 weeks, 18 weeks, 30 weeksSponsors and contacts
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Source ClinicalTrials.gov