xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06039293</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00234526</org_study_id>
      <nct_id>NCT06039293</nct_id>
    </id_info>
    <brief_title>Program AACTIVE: African American's Coming Together to Increase Vital Exercise</brief_title>
    <official_title>Program AACTIVE: African American's Coming Together to Increase Vital Exercise</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Program AACTIVE will enroll 80 African American/Black men with type 2 diabetes and&#xD;
        depression. Participants will be randomized to either the intervention arm or the control&#xD;
        arm. Participants in the intervention arm will receive talk therapy and physical activity&#xD;
        sessions over 12 weeks. Talk therapy and physical activity sessions will take place via a&#xD;
        video conferencing platform. There will also be 3 in-person health assessments including&#xD;
        baseline, at 12-weeks and 3-month follow up. The investigators are interested in seeing if&#xD;
        physical activity and talk therapy improve A1C outcomes and depression symptoms for&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Hemoglobin A1C %</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>Finger poke</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Depressive Symptoms</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood Pressure</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart Rate</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>Digital Blood Pressure Machine (with heart rate measure)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical Activity Minutes Each Week</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>Minutes of physical activity each week logged in a physical activity diary.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Steps</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>Pedometer readings</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diabetes Quality of Life</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>The Diabetes Quality of Life Brief Clinical Inventory contains 15 items, with response options ranging from 1 (&quot;Very Satisfied&quot;) to 5 (&quot;Very Dissatisfied&quot;). Possible scores range from 15 to 75. Lower scores suggest a satisfactory quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Quality of Life</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Diabetes Self-Efficacy</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>Perceived Diabetes Self-Management Scale (PDSMS). The responses for the PDSMS items range from 1 = &quot;Strongly Disagree&quot; to 5 = &quot;Strongly Agree.&quot; Four of the items (#s 1, 2, 6, &amp; 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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Masculinity Ideology</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>Conformity to Masculine Norms Inventory (CMNI-30). The 30-item scale contains 10 subscales (three items per subscale). Response options range from 0 (&quot;strongly disagree&quot;) to 5 (&quot;strongly agree&quot;). Items within each subscale are averaged and then summed across all subscales. Higher scores represent stronger conformity to traditional masculine norms.</description>
    </other_outcome>
    <other_outcome>
      <measure>BMI</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>kilograms/meters squared</description>
    </other_outcome>
    <other_outcome>
      <measure>Social Support</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <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. &quot;As much as I would like&quot; receives a score of 5 and &quot;Much less than I would like&quot; 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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Diabetes-related Distress</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <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 (&quot;not a problem&quot;) to 5 (&quot;very serious problem&quot;). 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 &quot;elevated&quot; diabetes distress.</description>
    </other_outcome>
    <other_outcome>
      <measure>Prescribed Medication Adherence</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>Adherence to Refills and Medicines Scale for Diabetes (ARMS-D). ARMS-D is a 12-item scale with response options ranging from 1 (&quot;none of the time&quot;) to 4 (&quot;all of the time&quot;). Scores are summed (range: 12 to 48), where higher scores are indicative of greater difficulty taking diabetes medications.</description>
    </other_outcome>
    <other_outcome>
      <measure>Aerobic Capacity</measure>
      <time_frame>baseline, 3-months (post intervention), 6-months (3-month follow up)</time_frame>
      <description>6 Minute Walking Test</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Type 2 Diabetes</condition>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive behavioral therapy and physical activity sessions</intervention_name>
      <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.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Diabetes and Emotional Health Workbook</intervention_name>
      <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.</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  African American/Black males, ambulatory status, diagnosed with type 2 diabetes for&#xD;
               one year duration or longer, PHQ-9 score &gt;=15 with no self-reported psychotic&#xD;
               symptoms, live in the Metro-Detroit area, have reliable transportation to in-person&#xD;
               events.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Stage 2 hypertension as defined by JNCVIII, recent cardiac events, recent laser&#xD;
               surgery for proliferative retinopathy, history of stroke, lower limb amputation,&#xD;
               asensory peripheral neuropathy, aortic stenosis or other sever valvular heart disease,&#xD;
               atrial fibrillation, severe COPD (e.g., basal oxygen), class III or IV heart failure&#xD;
               or medical instability.&#xD;
  &#xD;
          Participants who are currently receiving psychotherapy services for the treatment of&#xD;
          depression from a mental health care provider will be excluded while participants who are&#xD;
          currently receiving only medication management from as psychiatrist will be included.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Male</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jaclynn Hawkins, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan, School of Social Work</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kate Kloss, MS</last_name>
      <phone>734-647-4843</phone>
      <email>klossk@umich.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Jaclynn Hawkins</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>We will not share individual participant data with other researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06039293
  org study id: HUM00234526
  nct id: NCT06039293
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Hemoglobin A1C %
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  description: Finger poke
  measure: Change in Depressive Symptoms
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  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.
  measure: Blood Pressure
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  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.
  measure: Heart Rate
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  description: Digital Blood Pressure Machine (with heart rate measure)
  measure: Physical Activity Minutes Each Week
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  description: Minutes of physical activity each week logged in a physical activity diary.
  measure: Number of Steps
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  description: Pedometer readings
  measure: Diabetes Quality of Life
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  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.
  measure: General Quality of Life
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  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.
  measure: Diabetes Self-Efficacy
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  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.
  measure: Masculinity Ideology
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  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.
  measure: BMI
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  description: kilograms/meters squared
  measure: Social Support
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  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.
  measure: Diabetes-related Distress
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  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.
  measure: Prescribed Medication Adherence
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  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.
  measure: Aerobic Capacity
  time frame: baseline, 3-months (post intervention), 6-months (3-month follow up)
  description: 6 Minute Walking Test
  arm group label: Intervention
  arm group type: Experimental
  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 group label: Control
  arm group type: Other
  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: Cognitive behavioral therapy and physical activity sessions
  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.
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: Diabetes and Emotional Health Workbook
  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.
  arm group label: Control
  arm group label: Intervention
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jaclynn Hawkins, PhD
  role: Principal Investigator
  affiliation: University of Michigan, School of Social Work
  last name: Kate Kloss, MS
  phone: 734-647-4843
  email: klossk@umich.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Jaclynn Hawkins
  investigator title: Associate Professor
  mesh term: Depression
  sharing ipd: No
  ipd description: We will not share individual participant data with other researchers.