Program AACTIVE: African Americans Coming Together to Increase Vital Exercise
- Conditions
- Type 2 DiabetesDepression
- Interventions
- Behavioral: Cognitive behavioral therapy and physical activity sessionsBehavioral: Enhanced Usual Care + Diabetes Basics Web Series
- Registration Number
- NCT06039293
- Lead Sponsor
- University of Michigan
- Brief Summary
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 counseling (cognitive behavioral therapy) and physical activity sessions over 12 weeks. Counseling 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 counseling improve A1C outcomes and depression symptoms for participants.
- Detailed Description
Participants will be randomized to the Program AACTIVE intervention group or an Enhanced Usual Care (EUC) group. 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
- 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 Wayne or Washtenaw Counties, have reliable transportation to in-person events, have reliable access to internet and a device that supports video calls.
- Stage 2 hypertension as defined by JNCVIII, recent cardiac events, recent laser surgery for proliferative retinopathy, history of stroke, lower limb amputation, 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Cognitive behavioral therapy and physical activity sessions Participants will receive 10 cognitive behavioral therapy sessions and 6 physical activity sessions over 12 weeks. Participants in this group will also be assigned exercise goals. Exercise goals will be adapted to accommodate the physical and medical restrictions of older adults with type 2 diabetes. Exercise goals consistent with our prior trials will be used using a stepwise approach starting with 100 minutes of aerobic activity in week 1, 125 minutes in week 2 and 150 minutes in weeks 3 through 12. Exercise prescriptions will be based on the results obtained from the 6 Minute Walk Test obtained at baseline Control Enhanced Usual Care + Diabetes Basics Web Series Participants in the control group will receive enhanced usual care and will not take part in cognitive behavioral therapy sessions or exercise sessions. The EUC group will receive the American Diabetes Association "Diabetes Basics" web series (one video per week for 10 weeks) or "Diabetes Basics" handouts sent via mail.
- Primary Outcome Measures
Name Time Method Change in Hemoglobin A1C % baseline, 3-months (post intervention), 6-months (3-month follow up) Finger poke
Blood Pressure baseline, 3-months (post intervention), 6-months (3-month follow up) 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.
Change in Depressive Symptoms baseline, 3-months (post intervention), 6-months (3-month follow up) 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.
Heart Rate baseline, 3-months (post intervention), 6-months (3-month follow up) Digital Blood Pressure Machine (with heart rate measure)
Physical Activity Minutes Each Week Weekly, for intervention period between baseline and 3 months (post intervention) Minutes of physical activity each week logged in a physical activity log.
Number of Steps Weekly, for intervention period between baseline and 3 months (post intervention) Fitbit (provided by the study) readings and physical activity log
- Secondary Outcome Measures
Name Time Method Diabetes Quality of Life baseline, 3-months (post intervention), 6-months (3-month follow up) 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.
General Quality of Life baseline, 3-months (post intervention), 6-months (3-month follow up) 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.