Back to resultsProgram AACTIVE: African American's Coming Together to Increase Vital Exercise
Primary Purpose
Type 2 Diabetes, Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive behavioral therapy and physical activity sessions
Diabetes and Emotional Health Workbook
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
Participants will receive 10 cognitive behavioral therapy sessions and 6 physical activity sessions over 12 weeks. Additionally, participants in this group 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.
Participants in the control group will receive enhanced usual care and will not take part in cognitive behavioral therapy sessions or exercise sessions. Participants in this group 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.
Outcomes
Primary Outcome Measures
Change in Hemoglobin A1C %
Finger poke
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.
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.
Heart Rate
Digital Blood Pressure Machine (with heart rate measure)
Physical Activity Minutes Each Week
Minutes of physical activity each week logged in a physical activity diary.
Number of Steps
Pedometer readings
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT06039293
First Posted
August 25, 2023
Last Updated
September 8, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT06039293
Brief Title
Program AACTIVE: African American's Coming Together to Increase Vital Exercise
Official Title
Program AACTIVE: African American's Coming Together to Increase Vital Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will receive 10 cognitive behavioral therapy sessions and 6 physical activity sessions over 12 weeks. Additionally, participants in this group 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.
Arm Title
Control
Arm Type
Other
Arm Description
Participants in the control group will receive enhanced usual care and will not take part in cognitive behavioral therapy sessions or exercise sessions. Participants in this group 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy and physical activity sessions
Intervention Description
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
Intervention Name(s)
Diabetes and Emotional Health Workbook
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1C %
Description
Finger poke
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Change in Depressive Symptoms
Description
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.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Blood Pressure
Description
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.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Heart Rate
Description
Digital Blood Pressure Machine (with heart rate measure)
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Physical Activity Minutes Each Week
Description
Minutes of physical activity each week logged in a physical activity diary.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Number of Steps
Description
Pedometer readings
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Secondary Outcome Measure Information:
Title
Diabetes Quality of Life
Description
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.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
General Quality of Life
Description
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.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Other Pre-specified Outcome Measures:
Title
Diabetes Self-Efficacy
Description
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.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Masculinity Ideology
Description
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.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
BMI
Description
kilograms/meters squared
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Social Support
Description
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.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Diabetes-related Distress
Description
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.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Prescribed Medication Adherence
Description
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.
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
Title
Aerobic Capacity
Description
6 Minute Walking Test
Time Frame
baseline, 3-months (post intervention), 6-months (3-month follow up)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Kloss, MS
Phone
734-647-4843
Email
klossk@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaclynn Hawkins, PhD
Organizational Affiliation
University of Michigan, School of Social Work
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not share individual participant data with other researchers.
Learn more about this trial
Program AACTIVE: African American's Coming Together to Increase Vital Exercise
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