Depression, Depressive Symptoms, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALExercise
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.
BEHAVIORALGroup 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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. Per American College of Sports Medicine (ACSM) guidelines, medical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1C | Screening, Baseline, 10 weeks, 18 weeks, 30 weeks | Anthropometric/clinical data |
| Change in General Quality of Life (12-Item Short Form Survey (SF-12)) | Baseline, 10 weeks, 18 weeks, 30 weeks | 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. |
| Change in Diabetes-Related Distress (The Type 2 Diabetes Distress Assessment System) | Baseline, 10 weeks, 18 weeks, 30 weeks | 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. |
| Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument) | Baseline, 10 weeks, 18 weeks, 30 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Self-Efficacy (Perceived Diabetes Self-Management Scale) | Baseline, 10 weeks, 18 weeks, 30 weeks | 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. |
Countries
United States
Contacts
CONTACTJaclynn Hawkins, PhD
CONTACTHannah Burgess, MPH
PRINCIPAL_INVESTIGATORJaclynn Hawkins, PhD
University of Michigan, School of Social Work
Outcome results
None listed