Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT06574035
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2024-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Michigan Men's Diabetes Project III(MenDIII): Mind and Motion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Masculinity Ideology (The Conformity to Masculine Norms Inventory-30)', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': "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."}, {'measure': 'Change in BMI', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': 'Anthropometric/clinical data'}, {'measure': 'Chance in Estimated Abdominal Subcutaneous and Visceral Fat Stores', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': 'Anthropometric/clinical data'}, {'measure': 'Change in Diabetes Social Support (Duke/UNC Functional Social Support)', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': 'Survey Data - Responses are scaled on a 1-5 scale and tallied to create a total score with higher values indicating greater social support.'}, {'measure': 'Sociodemographic characteristics', 'timeFrame': 'Baseline', 'description': 'Survey Data'}, {'measure': 'Healthcare utilization', 'timeFrame': 'Baseline', 'description': 'Survey Data'}, {'measure': 'Comorbidities', 'timeFrame': 'Baseline', 'description': 'Survey Data'}, {'measure': 'Change in Medication Adherence (Adherence to Refills and Medicines Scale for Diabetes)', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': '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.'}, {'measure': 'Change in Aerobic Capacity (6 minute walk test)', 'timeFrame': 'Baseline, 10 weeks, 30 weeks', 'description': 'Anthropometric/clinical data'}, {'measure': 'Change in Working Alliance between Counselor & Participant (Working Alliance Inventory - Short Revised)', 'timeFrame': 'Up to 8 weeks', 'description': '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.'}, {'measure': 'Change in Metabolic Control (continuous blood glucose levels)', 'timeFrame': 'Up to 18 weeks', 'description': 'Anthropometric/clinical data'}, {'measure': 'Change in Depression Symptoms (Patient Health Questionnaire 9)', 'timeFrame': 'Screening and throughout study completion, up to 30 weeks.', 'description': '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.'}, {'measure': 'Change in Blood Pressure (systolic and diastolic)', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': 'Anthropometric/clinical data'}, {'measure': 'Change in Physical Activity Regimen', 'timeFrame': 'Up to 18 weeks', 'description': 'Exercise Log Data'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': 'Anthropometric/clinical data'}], 'primaryOutcomes': [{'measure': 'Change in A1C', 'timeFrame': 'Screening, Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': 'Anthropometric/clinical data'}, {'measure': 'Change in General Quality of Life (12-Item Short Form Survey (SF-12))', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': '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.'}, {'measure': 'Change in Diabetes-Related Distress (The Type 2 Diabetes Distress Assessment System)', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': "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."}, {'measure': 'Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument)', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale)', 'timeFrame': 'Baseline, 10 weeks, 18 weeks, 30 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Depressive Symptoms', 'Depression']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-representation of gender identity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American/Black 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/phone/computer 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://redcapproduction.umms.med.umich.edu/surveys/?s=JNPPEDANX7KLPPF9. Thank you so much!'}, 'identificationModule': {'nctId': 'NCT06574035', 'acronym': 'MenDIII', 'briefTitle': "Michigan Men's Diabetes Project III(MenDIII): Mind and Motion", 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': "Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion", 'orgStudyIdInfo': {'id': 'HUM00256519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': '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.\n\nParticipants in this group will also receive 8 one hour virtual sessions of individual exercise.\n\nParticipants 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.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy', 'Behavioral: Exercise', 'Behavioral: Group Discussions - Ongoing Support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants randomized to the control group will receive enhanced usual care (EUC). The EUC group will receive 8 sessions of standard Cognitive Behavioral Therapy.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Group Discussions - Ongoing Support', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jaclynn Hawkins, PhD', 'role': 'CONTACT', 'email': 'jachawk@umich.edu', 'phone': '734-615-2817'}, {'name': 'Hannah Burgess, MPH', 'role': 'CONTACT', 'email': 'hlburges@umich.ed', 'phone': '(734)-210-1756'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Jaclynn Hawkins, PhD', 'role': 'CONTACT', 'email': 'jachawk@umich.edu', 'phone': '(734) 615-2817'}, {'name': 'Hannah Burgess, MPH', 'role': 'CONTACT', 'email': 'hlburges@umich.edu', 'phone': '(734)-210-1756'}], 'overallOfficials': [{'name': 'Jaclynn Hawkins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan, School of Social Work'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jaclynn Hawkins', 'investigatorAffiliation': 'University of Michigan'}}}}