Clinical trial NCT06039293: Program AACTIVE: African Americans Coming Together to Increase Vital Exercise
Official title: Program AACTIVE: African Americans Coming Together to Increase Vital Exercise
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes
Depression
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 Wayne or Washtenaw Counties, have reliable transportation to in-person events, have reliable access to internet and a device that supports video calls.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Hemoglobin A1C %
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: Change in Depressive Symptoms
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: Blood Pressure
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: Heart Rate
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: Physical Activity Minutes Each Week
timeFrame: Weekly, for intervention period between baseline and 3 months (post intervention)
measure: Number of Steps
timeFrame: Weekly, for intervention period between baseline and 3 months (post intervention)
Secondary outcomes:
measure: Diabetes Quality of Life
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: General Quality of Life
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
Other outcomes:
measure: Diabetes Self-Efficacy
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: Masculinity Ideology
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: BMI
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: Social Support
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: Diabetes-related Distress
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: Prescribed Medication Adherence
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
measure: Aerobic Capacity
timeFrame: baseline, 3-months (post intervention), 6-months (3-month follow up)
Locations:
Study officials:
affiliation: University of Michigan, School of Social Work
name: Jaclynn Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: