Program AACTIVE: African American's Coming Together to Increase Vital Exercise

Study Overview
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Brief Summary
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Program AACTIVE will enroll 80 African American/Black men with type 2 diabetes and depression. Participants will be randomized to either the intervention arm or the control arm. Participants in the intervention arm will receive talk therapy and physical activity sessions over 12 weeks. Talk therapy and physical activity sessions will take place via a video conferencing platform. There will also be 3 in-person health assessments including baseline, at 12-weeks and 3-month follow up. The investigators are interested in seeing if physical activity and talk therapy improve A1C outcomes and depression symptoms for participants.

Official Title
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Program AACTIVE: African American's Coming Together to Increase Vital Exercise

Conditions
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Type 2 Diabetes, Depression

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy and physical activity sessions
* Behavioral: Diabetes and Emotional Health Workbook


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American/Black males, ambulatory status, diagnosed with type 2 diabetes for one year duration or longer, PHQ-9 score >=15 with no self-reported psychotic symptoms, live in the Metro-Detroit area, have reliable transportation to in-person events. Exclusion Criteria: Stage 2 hypertension as defined by JNCVIII, recent cardiac events, recent laser surgery for proliferative retinopathy, history of stroke, lower limb amputation, asensory peripheral neuropathy, aortic stenosis or other sever valvular heart disease, atrial fibrillation, severe COPD (e.g., basal oxygen), class III or IV heart failure or medical instability. Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health care provider will be excluded while participants who are currently receiving only medication management from as psychiatrist will be included.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will receive 10 cognitive behavioral therapy sessions and 6 physical activity sessions over 12 weeks. Additionally, participants in this group will receive an adapted copy of the American Diabetes Association's 2021 Diabetes and Emotional Health Workbook: A Practical Guide for Health Professionals Supporting Adults with Type 1 and Type 2 Diabetes. | Behavioral: Cognitive behavioral therapy and physical activity sessions<br>* The intervention group will receive 10 sessions of cognitive behavioral therapy (CBT) and 6 physical activity sessions over the 12-week period. All Program AACTIVE CBT sessions and exercise sessions will run concurrently and take place virtually using Master of Social Work (MSW) trainees and Movement Science Master of Science students from the University of Michigan.<br>Behavioral: Diabetes and Emotional Health Workbook<br>* Participants will receive an adapted copy of the American Diabetes Association's 2021 Diabetes and Emotional Health Workbook: A Practical Guide for Health Professionals Supporting Adults with Type 1 and Type 2 Diabetes.<br>|
| Other: Control<br>Participants in the control group will receive enhanced usual care and will not take part in cognitive behavioral therapy sessions or exercise sessions. Participants in this group will receive an adapted copy of the American Diabetes Association's 2021 Diabetes and Emotional Health Workbook: A Practical Guide for Health Professionals Supporting Adults with Type 1 and Type 2 Diabetes. | Behavioral: Diabetes and Emotional Health Workbook<br>* Participants will receive an adapted copy of the American Diabetes Association's 2021 Diabetes and Emotional Health Workbook: A Practical Guide for Health Professionals Supporting Adults with Type 1 and Type 2 Diabetes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1C % | Finger poke | baseline, 3-months (post intervention), 6-months (3-month follow up) | 
| Change in Depressive Symptoms | Patient Health Questionnaire-9 Scale, a scale to measure depression severity. Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression. | baseline, 3-months (post intervention), 6-months (3-month follow up) | 
| Blood Pressure | Digital Blood Pressure Machine measuring systolic and diastolic blood pressure. Blood pressures will be measured twice and averaged. The average will be recorded as the blood pressure reading. | baseline, 3-months (post intervention), 6-months (3-month follow up) | 
| Heart Rate | Digital Blood Pressure Machine (with heart rate measure) | baseline, 3-months (post intervention), 6-months (3-month follow up) | 
| Physical Activity Minutes Each Week | Minutes of physical activity each week logged in a physical activity diary. | baseline, 3-months (post intervention), 6-months (3-month follow up) | 
| Number of Steps | Pedometer readings | baseline, 3-months (post intervention), 6-months (3-month follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Quality of Life | The Diabetes Quality of Life Brief Clinical Inventory contains 15 items, with response options ranging from 1 (Very Satisfied) to 5 (Very Dissatisfied). Possible scores range from 15 to 75. Lower scores suggest a satisfactory quality of life. | baseline, 3-months (post intervention), 6-months (3-month follow up) | 
| General Quality of Life | Short Form-12 Scale (SF-12). The 12 response options are coded as follows: 1=yes, limited a lot; 2=yes, limited a little; 3=no, not limited at all. A higher score is indicative of better health. | baseline, 3-months (post intervention), 6-months (3-month follow up) |