Program AACTIVE: African Americans Coming Together to Increase Vital Exercise

NCT06039293 | Withdrawn

• 1 other identifier: HUM00234526
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes; Depression

Outcome Measures

Primary Outcomes (6)

• 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 log.

  Weekly, for intervention period between baseline and 3 months (post intervention)

• Number of Steps

  Fitbit (provided by the study) readings and physical activity log

  Weekly, for intervention period between baseline and 3 months (post intervention)

Secondary Outcomes (2)

• Diabetes Quality of Life

  baseline, 3-months (post intervention), 6-months (3-month follow up)

• General Quality of Life

  baseline, 3-months (post intervention), 6-months (3-month follow up)

Other Outcomes (7)

• Diabetes Self-Efficacy

  baseline, 3-months (post intervention), 6-months (3-month follow up)

• Masculinity Ideology

  baseline, 3-months (post intervention), 6-months (3-month follow up)

• BMI

  baseline, 3-months (post intervention), 6-months (3-month follow up)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Cognitive behavioral therapy and physical activity sessions

Control

OTHER

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.

Behavioral: Enhanced Usual Care + Diabetes Basics Web Series

Interventions

Cognitive behavioral therapy and physical activity sessions 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.

Intervention

Enhanced Usual Care + Diabetes Basics Web Series 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jaclynn Hawkins, PhD

  University of Michigan, School of Social Work

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 15, 2023
• Study Start: June 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share