Program AACTIVE: African Americans Coming Together to Increase Vital Exercise

NCT ID: NCT06039293

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-10-31

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.

Conditions

Type 2 Diabetes; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Cognitive behavioral therapy and physical activity sessions

Intervention Type: BEHAVIORAL

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.

Control

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.

Group Type: OTHER

Enhanced Usual Care + Diabetes Basics Web Series

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jaclynn Hawkins

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaclynn Hawkins, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, School of Social Work

Other Identifiers

HUM00234526

Identifier Type: -

Identifier Source: org_study_id