[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06574035":3,"trial-entities:NCT06574035":134,"trial-summary:NCT06574035":138},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":46,"secondary_outcomes":61,"sex":65,"minimum_age":66,"maximum_age":17,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":102,"locations":105,"central_contacts":124,"overall_officials":128,"references":132,"see_also_links":133},"NCT06574035","HUM00256519","Michigan Men's Diabetes Project III(MenDIII): Mind and Motion","Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion","RECRUITING","2026-09","2026-03","2026-06-12","2025-01-13","University of Michigan","OTHER",true,"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\u002Fphone\u002Fcomputer 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\u002Fsessions 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.",null,[19,20,21],"Diabetes Mellitus, Type 2","Depressive Symptoms","Depression",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[26],"NA",{"count":28,"type":29},80,"ESTIMATED",[31,38,42],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Cognitive Behavioral Therapy","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.",[36,37],"Control Group","Intervention Group",{"type":32,"name":39,"description":40,"armGroupLabels":41},"Exercise","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.",[37],{"type":32,"name":43,"description":44,"armGroupLabels":45},"Group Discussions - Ongoing Support","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.",[37],[47,51,55,58],{"measure":48,"description":49,"timeFrame":50},"Change in A1C","Anthropometric\u002Fclinical data","Screening, Baseline, 10 weeks, 18 weeks, 30 weeks",{"measure":52,"description":53,"timeFrame":54},"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",{"measure":56,"description":57,"timeFrame":54},"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 \\\u003C 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.",{"measure":59,"description":60,"timeFrame":54},"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).",[62],{"measure":63,"description":64,"timeFrame":54},"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.","MALE","18 Years",false,{"inclusion":69,"exclusion":79,"raw_text":101},[70,71,72,73,74,75,76,77,78],"African American\u002FBlack 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\u002Fphone\u002Fcomputer to complete study related tasks","live in the Wayne or Washtenaw County\\\\","have reliable transportation to in-person events",[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"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","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.","Inclusion Criteria:\n\n* African American\u002FBlack males\n* age 18 years or older\n* ambulatory status\n* diagnosis of Type 2 Diabetes (T2D) for one year duration or longer\n* be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year\n* be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments)\n* have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet\u002Fphone\u002Fcomputer to complete study related tasks\n* live in the Wayne or Washtenaw County\\\\\n* have reliable transportation to in-person events\n\nExclusion Criteria:\n\n* stage 2 hypertension as defined by Joint National Committee (JNC) VIII\n* recent cardiac events\n* recent laser surgery for proliferative retinopathy\n* history of stroke\n* lower limb amputation\n* peripheral neuropathy\n* severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)\n* class III or IV heart failure\n* medical instability.\n\nPer American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing:\n\n* ongoing unstable angina\n* uncontrolled cardiac arrhythmia with hemodynamic compromise\n* active endocarditis\n* symptomatic severe aortic stenosis\n* acute myocarditis or pericarditis\n* acute aortic dissection\n* acute pulmonary embolism\n* pulmonary infarction\n* deep venous thrombosis\n* physical disability that precludes safe and adequate testing\n* chest discomfort with exertion\n* unreasonable breathlessness, or dizziness, fainting, or blackouts.\n\nAs 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.\n\nIf you are interested in the study, please complete our screening survey: https:\u002F\u002Fredcapproduction.umms.med.umich.edu\u002Fsurveys\u002F?s=JNPPEDANX7KLPPF9. Thank you so much!",[103,104],"ADULT","OLDER_ADULT",[106],{"facility":13,"status":8,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":121},"Ann Arbor","Michigan","48109","United States",[112,117],{"name":113,"role":114,"phone":115,"email":116},"Jaclynn Hawkins, PhD","CONTACT","(734) 615-2817","jachawk@umich.edu",{"name":118,"role":114,"phone":119,"email":120},"Hannah Burgess, MPH","(734)-210-1756","hlburges@umich.ed",{"lat":122,"lon":123},42.27756,-83.74088,[125,126],{"name":113,"role":114,"phone":115,"email":116},{"name":118,"role":114,"phone":119,"email":127},"hlburges@umich.edu",[129],{"name":113,"affiliation":130,"role":131},"University of Michigan, School of Social Work","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":135,"biomarkers":137},[21,136],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":139,"prompt_version":149},{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This is a 7-month pilot randomized clinical trial looking to enroll 80 Black men with type 2 diabetes.","completed","Michigan Men's Diabetes Project III: Mind and Motion","This study, called the Michigan Men's Diabetes Project III: Mind and Motion, is looking for 80 Black men aged 18 or older who have had type 2 diabetes for at least one year. You should also be under a doctor's care for your diabetes and have an A1C (a measure of blood sugar over time) of 7.0% or higher in the last year. The study will test if a combination of Cognitive Behavioral Therapy (a type of talk therapy), exercise, and group discussions can improve your A1C, overall quality of life, and reduce diabetes-related distress. The study will measure these changes at different points over 30 weeks. The current status of this study is unclear.","Your A1C, quality of life, and diabetes-related distress will be measured at 10, 18, and 30 weeks after the start of the study.",115,"You would participate in weekly physical activity, exercise, and Cognitive Behavioral Therapy (CBT) sessions, as well as group discussion sessions and in-person health assessments. You also need reliable internet access.","Not stated in the trial record.",[33,39],"v2"]