Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion
NCT Number: NCT06574035
Acronym: MenDIII
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2|Depressive Symptoms|Depression
Interventions: BEHAVIORAL: Cognitive Behavioral Therapy|BEHAVIORAL: Exercise|BEHAVIORAL: Group Discussions - Ongoing Support
Sponsor: University of Michigan
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2026-06
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States

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) and with depression (Patient Health Questionnaire - 9 score over 5) 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.

Primary Outcome Measures: Change in A1C, Anthropometric/clinical data, Screening, Baseline, 10 weeks, 18 weeks, 30 weeks|Change in Blood Pressure (systolic and diastolic), Anthropometric/clinical data, Baseline, 10 weeks, 18 weeks, 30 weeks|Change in Heart Rate, Anthropometric/clinical data, Baseline, 10 weeks, 18 weeks, 30 weeks|Change in Depression Symptoms (Patient Health Questionnaire 9), 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., Screening and throughout study completion, up to 30 weeks.|Change in Physical Activity Regimen, Exercise Log Data, Up to 18 weeks
Secondary Outcome Measures: 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|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
Other Outcome Measures: 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., Baseline, 10 weeks, 18 weeks, 30 weeks|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., Baseline, 10 weeks, 18 weeks, 30 weeks|Change in BMI, Anthropometric/clinical data, Baseline, 10 weeks, 18 weeks, 30 weeks|Chance in Estimated Abdominal Subcutaneous and Visceral Fat Stores, Anthropometric/clinical data, Baseline, 10 weeks, 18 weeks, 30 weeks|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., 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|Sociodemographic characteristics, Survey Data, Baseline|Healthcare utilization, Survey Data, Baseline|Comorbidities, Survey Data, Baseline|Change in Medication Adherence (Adherence to Refills and Medicines Scale for Diabetes), 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., Baseline, 10 weeks, 18 weeks, 30 weeks|Change in Aerobic Capacity (6 minute walk test), Anthropometric/clinical data, Baseline, 10 weeks, 30 weeks|Change in Working Alliance between Counselor & Participant (Working Alliance Inventory - Short Revised), 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., Up to 8 weeks|Change in Metabolic Control (continuous blood glucose levels), Anthropometric/clinical data, Up to 18 weeks