Program AACTIVE: African American's Coming Together to Increase Vital Exercise

Depression Clinical Trial

Official title:

Program AACTIVE: African American's Coming Together to Increase Vital Exercise

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06039293
• Other study ID #: HUM00234526
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Hannah Burgess
• Phone: (734) 647-4074
• Email: hlburges[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 talk therapy and physical activity sessions over 12 weeks. Talk therapy 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 talk therapy improve A1C outcomes and depression symptoms for participants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Metro-Detroit area, have reliable transportation to in-person events.

Exclusion Criteria:

• Stage 2 hypertension as defined by JNCVIII, recent cardiac events, recent laser surgery for proliferative retinopathy, history of stroke, lower limb amputation, asensory 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.

Related Conditions & MeSH terms

• Depression
• Type 2 Diabetes

Intervention

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.
• Diabetes and Emotional Health Workbook
Participants will receive an adapted copy of the American Diabetes Association's 2021 Diabetes and Emotional Health Workbook: A Practical Guide for Health Professionals Supporting Adults with Type 1 and Type 2 Diabetes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diabetes Self-Efficacy	Perceived Diabetes Self-Management Scale (PDSMS). The responses for the PDSMS items range from 1 = "Strongly Disagree" to 5 = "Strongly Agree." Four of the items (#s 1, 2, 6, & 7) are worded such that high agreement signifies low self-efficacy or perceived competence. These four items are reverse scored prior to being added to the other four items. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.	baseline, 3-months (post intervention), 6-months (3-month follow up)
Other	Masculinity Ideology	Conformity to Masculine Norms Inventory (CMNI-30). The 30-item scale contains 10 subscales (three items per subscale). Response options range from 0 ("strongly disagree") to 5 ("strongly agree"). Items within each subscale are averaged and then summed across all subscales. Higher scores represent stronger conformity to traditional masculine norms.	baseline, 3-months (post intervention), 6-months (3-month follow up)
Other	BMI	kilograms/meters squared	baseline, 3-months (post intervention), 6-months (3-month follow up)
Other	Social Support	Duke-UNC Functional Social Support Questionnaire. This is an 8 question scale and responses to each question are scored on a 1 to 5 scale. "As much as I would like" receives a score of 5 and "Much less than I would like" receives a score of 1. The scores from all eight questions are summed (maximum 40) and then divided by 8 to get an average score. The higher the average score, the greater the perceived social support.	baseline, 3-months (post intervention), 6-months (3-month follow up)
Other	Diabetes-related Distress	Type 2 Diabetes Distress Assessment System. The scale is comprised of an 8-item Core Tool, and a Sources Tool that examines seven distinct Sources of diabetes distress, each containing three items. On a 5-point Likert scale, response options range from 1 ("not a problem") to 5 ("very serious problem"). A higher Core diabetes distress score has been associated with higher HbA1c levels, BMI, and poorer self-management behaviors. There are no established thresholds for what would be considered "elevated" diabetes distress.	baseline, 3-months (post intervention), 6-months (3-month follow up)
Other	Prescribed Medication Adherence	Adherence to Refills and Medicines Scale for Diabetes (ARMS-D). ARMS-D is a 12-item scale with response options ranging from 1 ("none of the time") to 4 ("all of the time"). Scores are summed (range: 12 to 48), where higher scores are indicative of greater difficulty taking diabetes medications.	baseline, 3-months (post intervention), 6-months (3-month follow up)
Other	Aerobic Capacity	6 Minute Walking Test	baseline, 3-months (post intervention), 6-months (3-month follow up)
Primary	Change in Hemoglobin A1C %	Finger poke	baseline, 3-months (post intervention), 6-months (3-month follow up)
Primary	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)
Primary	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)
Primary	Heart Rate	Digital Blood Pressure Machine (with heart rate measure)	baseline, 3-months (post intervention), 6-months (3-month follow up)
Primary	Physical Activity Minutes Each Week	Minutes of physical activity each week logged in a physical activity diary.	baseline, 3-months (post intervention), 6-months (3-month follow up)
Primary	Number of Steps	Pedometer readings	baseline, 3-months (post intervention), 6-months (3-month follow up)
Secondary	Diabetes Quality of Life	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.	baseline, 3-months (post intervention), 6-months (3-month follow up)
Secondary	General Quality of Life	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.	baseline, 3-months (post intervention), 6-months (3-month follow up)