NCT06039293

Program AACTIVE: African Americans Coming Together to Increase Vital Exercise

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive behavioral therapy and physical activity sessions	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.
BEHAVIORAL	Enhanced Usual Care + Diabetes Basics Web Series	Participants will receive the American Diabetes Association "Diabetes Basics" web series (one video per week for 10 weeks) or "Diabetes Basics" handouts sent via mail.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2023-09-15
• Last updated: 2024-08-23