<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/NCT03839212</url>
  </required_header>
  <id_info>
    <org_study_id>20181032</org_study_id>
    <secondary_id>U54MD002266</secondary_id>
    <nct_id>NCT03839212</nct_id>
  </id_info>
  <brief_title>The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men</brief_title>
  <acronym>HOLAHIV</acronym>
  <official_title>Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the feasibility of an intervention to prevent chronic&#xD;
      diseases like diabetes, high blood pressure, and obesity in midlife and older Latino adults&#xD;
      living with HIV. The investigators expect that the participant will be in this study for&#xD;
      seven months. Participants will be interviewed and asked to take part in walking groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">October 27, 2020</completion_date>
  <primary_completion_date type="Actual">July 27, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Eligible Participants Refusing to Participate.</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of eligible participants refusing to participate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention Rate</measure>
    <time_frame>Up to 3 months post intervention</time_frame>
    <description>Retention rate will be reported as the number of participants completing the post-intervention assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of Intervention</measure>
    <time_frame>Up to week 16</time_frame>
    <description>As measured by the total number of sessions attended by the participants as a whole.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Cardiometabolic Risk as Measured by Waist Circumference</measure>
    <time_frame>Baseline, 7 months post intervention</time_frame>
    <description>As measured by the number of inches around the participant's waist. A waist circumference of 102 centimetres (40 inches) or more in men is associated with health problems such as type 2 diabetes, heart disease and high blood pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychosocial Functioning as Measured by Depression Severity Scale</measure>
    <time_frame>Baseline, Month 4, Month 7</time_frame>
    <description>As measured by a 20-item Center for Epidemiologic Studies Depression (CES-D) scale. The possible range of scores are 0 to 60 with the higher scores indicating the presence of more symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)</measure>
    <time_frame>Baseline, Month 4, Month 7</time_frame>
    <description>The SF-12v2 is a measure of health related quality of life and provides 2 scores 1) Mental Component Summary Score (MCS) and 2) Physical Component Summary Score (PCS). MCS scores range from 0 to 100, higher scores indicate better mental health related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Baseline, Month 4, Month 7</time_frame>
    <description>severity of depression will be measured by the 9-item PHQ-9. Scores range from 0 to 27. With scores of 1-4 indicating minimal depression and scores of 20-27 indicating severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale</measure>
    <time_frame>Baseline, Month 4, Month 7</time_frame>
    <description>The 7-item Generalized Anxiety Disorder (GAD-7) scale will be used to measure the severity of anxiety. The scores range from 0 to 21 with scores of 0 to 5 indicating mild anxiety and scores of 15-21 indicating severe anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale</measure>
    <time_frame>Baseline, Month 4, Month 7</time_frame>
    <description>The 14 item Healthy Families Program Perceived Stress Scale will be used to measure the severity of anxiety. PSS scores can range from 0 to 40 with higher scores indicated higher perception of stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychosocial Functioning as Measured by the Social Support Received</measure>
    <time_frame>Baseline, Month 4, Month 7</time_frame>
    <description>The 12 item Multidimensional Scale of Perceived Social support. After calculating the mean score across the categories a mean scale support score from 1 to 2.9 would indicate low support, whereas a mean score of 5.1 to 7 would indicate high support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides</measure>
    <time_frame>Baseline, Month 4, Month 7</time_frame>
    <description>A total cholesterol value of less than 200 mg/dL (5.18 mmol/L) is desirable and 240 mg/dL (6.22 mmol/L) or higher is high. Average HDL-C level is 40-50 mg/dL (1.0-1.3 mmol/L) for men. Low HDL-C level, increased risk, is less than 40 mg/dL (1.0 mmol/L). Optimal LDL-C levels are less than 100 mg/d while high levels are 160-189 mg/dL (4.15-4.90 mmol/L). Desirable triglyceride levels are less than 150 mg/dL (1.70 mmol/L) while high levels are considered 200-499 mg/dL (2.3-5.6 mmol/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.</measure>
    <time_frame>Baseline, Month 4, Month 7</time_frame>
    <description>Normal systolic and diastolic pressure is less than 120 mmHg and 80mmHg, respectively. High systolic and diastolic pressure is 140 mmHg or higher and 90 mmHg or higher, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)</measure>
    <time_frame>Baseline, Month 4, Month 7</time_frame>
    <description>The normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean a higher chance of getting diabetes. Levels of 6.5% or higher mean diabetes.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <condition>Cardiometabolic Risk</condition>
  <arm_group>
    <arm_group_label>Happy Older Latinos are Active (HOLA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 16-week multi-component, health promotion intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HOLA Component 1</intervention_name>
    <description>At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.</description>
    <arm_group_label>Happy Older Latinos are Active (HOLA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HOLA Component 2</intervention_name>
    <description>A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.</description>
    <arm_group_label>Happy Older Latinos are Active (HOLA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HOLA Component 3</intervention_name>
    <description>A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.</description>
    <arm_group_label>Happy Older Latinos are Active (HOLA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HOLA Component 4</intervention_name>
    <description>One booster walking session twice a month for three months post intervention for reinforcement.</description>
    <arm_group_label>Happy Older Latinos are Active (HOLA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  are Latino (self-identified);&#xD;
&#xD;
          -  are age 50+ years;&#xD;
&#xD;
          -  are male;&#xD;
&#xD;
          -  are HIV infected but are virologically suppressed (viral load &lt;200 copies/mL);&#xD;
&#xD;
          -  volunteer informed consent;&#xD;
&#xD;
          -  have medical clearance by a physician;&#xD;
&#xD;
          -  expect to stay in Miami for the next 6 months; and&#xD;
&#xD;
          -  have documented risk of cardiometabolic disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes diagnosis;&#xD;
&#xD;
          -  at baseline meet criteria for current major depressive disorder or generalized anxiety&#xD;
             disorder;&#xD;
&#xD;
          -  meet criteria for current alcohol or other substance abuse disorders;&#xD;
&#xD;
          -  have a lifetime history of bipolar disorder or other psychotic disorder;&#xD;
&#xD;
          -  have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease,&#xD;
             Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive&#xD;
             impairment as indicated by a Mini Mental Status Exam score &lt;24;&#xD;
&#xD;
          -  have contraindications to physical activity outlined in the American College of Sports&#xD;
             Medicine standards;&#xD;
&#xD;
          -  have high suicide risk i.e., intent or plan to attempt suicide in the near future (a&#xD;
             response of &quot;yes&quot; to questions 3, 4, and/or 5 on the Paykel Questionnaire);&#xD;
&#xD;
          -  are unable to complete 10 m walk test;&#xD;
&#xD;
          -  currently residing in a nursing or group home;&#xD;
&#xD;
          -  have a terminal physical illness expected to result in the death within one year;&#xD;
&#xD;
          -  have an acute or severe medical illness that precludes them from safely participating&#xD;
             in a health promotion intervention.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Jimenez, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jackson Memorial Mental Health Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>July 21, 2021</results_first_submitted>
  <results_first_submitted_qc>July 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 16, 2021</results_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Daniel Enrique Jimenez</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>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 16, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03839212/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03839212/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Happy Older Latinos Are Active (HOLA)</title>
          <description>A 16-week multi-component, health promotion intervention&#xD;
HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.&#xD;
HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.&#xD;
HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.&#xD;
HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>COVID-19 related suspension of research activities.</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Happy Older Latinos Are Active (HOLA)</title>
          <description>A 16-week multi-component, health promotion intervention&#xD;
HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.&#xD;
HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.&#xD;
HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.&#xD;
HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.5" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Eligible Participants Refusing to Participate.</title>
        <description>Number of eligible participants refusing to participate.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Happy Older Latinos Are Active (HOLA)</title>
            <description>A 16-week multi-component, health promotion intervention&#xD;
HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.&#xD;
HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.&#xD;
HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.&#xD;
HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Eligible Participants Refusing to Participate.</title>
          <description>Number of eligible participants refusing to participate.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Retention Rate</title>
        <description>Retention rate will be reported as the number of participants completing the post-intervention assessment.</description>
        <time_frame>Up to 3 months post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Happy Older Latinos Are Active (HOLA)</title>
            <description>A 16-week multi-component, health promotion intervention&#xD;
HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.&#xD;
HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.&#xD;
HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.&#xD;
HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.</description>
          </group>
        </group_list>
        <measure>
          <title>Retention Rate</title>
          <description>Retention rate will be reported as the number of participants completing the post-intervention assessment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability of Intervention</title>
        <description>As measured by the total number of sessions attended by the participants as a whole.</description>
        <time_frame>Up to week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Happy Older Latinos Are Active (HOLA)</title>
            <description>A 16-week multi-component, health promotion intervention&#xD;
HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.&#xD;
HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.&#xD;
HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.&#xD;
HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of Intervention</title>
          <description>As measured by the total number of sessions attended by the participants as a whole.</description>
          <units>sessions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cardiometabolic Risk as Measured by Waist Circumference</title>
        <description>As measured by the number of inches around the participant's waist. A waist circumference of 102 centimetres (40 inches) or more in men is associated with health problems such as type 2 diabetes, heart disease and high blood pressure.</description>
        <time_frame>Baseline, 7 months post intervention</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Psychosocial Functioning as Measured by Depression Severity Scale</title>
        <description>As measured by a 20-item Center for Epidemiologic Studies Depression (CES-D) scale. The possible range of scores are 0 to 60 with the higher scores indicating the presence of more symptomatology.</description>
        <time_frame>Baseline, Month 4, Month 7</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)</title>
        <description>The SF-12v2 is a measure of health related quality of life and provides 2 scores 1) Mental Component Summary Score (MCS) and 2) Physical Component Summary Score (PCS). MCS scores range from 0 to 100, higher scores indicate better mental health related quality of life.</description>
        <time_frame>Baseline, Month 4, Month 7</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)</title>
        <description>severity of depression will be measured by the 9-item PHQ-9. Scores range from 0 to 27. With scores of 1-4 indicating minimal depression and scores of 20-27 indicating severe depression.</description>
        <time_frame>Baseline, Month 4, Month 7</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale</title>
        <description>The 7-item Generalized Anxiety Disorder (GAD-7) scale will be used to measure the severity of anxiety. The scores range from 0 to 21 with scores of 0 to 5 indicating mild anxiety and scores of 15-21 indicating severe anxiety.</description>
        <time_frame>Baseline, Month 4, Month 7</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale</title>
        <description>The 14 item Healthy Families Program Perceived Stress Scale will be used to measure the severity of anxiety. PSS scores can range from 0 to 40 with higher scores indicated higher perception of stress.</description>
        <time_frame>Baseline, Month 4, Month 7</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Psychosocial Functioning as Measured by the Social Support Received</title>
        <description>The 12 item Multidimensional Scale of Perceived Social support. After calculating the mean score across the categories a mean scale support score from 1 to 2.9 would indicate low support, whereas a mean score of 5.1 to 7 would indicate high support.</description>
        <time_frame>Baseline, Month 4, Month 7</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides</title>
        <description>A total cholesterol value of less than 200 mg/dL (5.18 mmol/L) is desirable and 240 mg/dL (6.22 mmol/L) or higher is high. Average HDL-C level is 40-50 mg/dL (1.0-1.3 mmol/L) for men. Low HDL-C level, increased risk, is less than 40 mg/dL (1.0 mmol/L). Optimal LDL-C levels are less than 100 mg/d while high levels are 160-189 mg/dL (4.15-4.90 mmol/L). Desirable triglyceride levels are less than 150 mg/dL (1.70 mmol/L) while high levels are considered 200-499 mg/dL (2.3-5.6 mmol/L).</description>
        <time_frame>Baseline, Month 4, Month 7</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.</title>
        <description>Normal systolic and diastolic pressure is less than 120 mmHg and 80mmHg, respectively. High systolic and diastolic pressure is 140 mmHg or higher and 90 mmHg or higher, respectively.</description>
        <time_frame>Baseline, Month 4, Month 7</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)</title>
        <description>The normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean a higher chance of getting diabetes. Levels of 6.5% or higher mean diabetes.</description>
        <time_frame>Baseline, Month 4, Month 7</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Happy Older Latinos Are Active (HOLA)</title>
          <description>A 16-week multi-component, health promotion intervention&#xD;
HOLA Component 1: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.&#xD;
HOLA Component 2: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.&#xD;
HOLA Component 3: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.&#xD;
HOLA Component 4: One booster walking session twice a month for three months post intervention for reinforcement.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>All clinical research activities at the University of Miami were suspended due to the Coronavirus Disease of 2019 (COVID-19) pandemic. As a result, data collection and participant retention were impacted.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Daniel E. Jimenez, Ph.D., Associate Professor</name_or_title>
      <organization>University of Miami</organization>
      <phone>3052432776</phone>
      <email>dej18@miami.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT03839212
org study id: 20181032
secondary id: U54MD002266
nct id: NCT03839212
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the feasibility of an intervention to prevent chronic
      diseases like diabetes, high blood pressure, and obesity in midlife and older Latino adults
      living with HIV. The investigators expect that the participant will be in this study for
      seven months. Participants will be interviewed and asked to take part in walking groups.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Eligible Participants Refusing to Participate.
time frame: Baseline
description: Number of eligible participants refusing to participate.
measure: Retention Rate
time frame: Up to 3 months post intervention
description: Retention rate will be reported as the number of participants completing the post-intervention assessment.
measure: Acceptability of Intervention
time frame: Up to week 16
description: As measured by the total number of sessions attended by the participants as a whole.
measure: Change in Cardiometabolic Risk as Measured by Waist Circumference
time frame: Baseline, 7 months post intervention
description: As measured by the number of inches around the participant's waist. A waist circumference of 102 centimetres (40 inches) or more in men is associated with health problems such as type 2 diabetes, heart disease and high blood pressure.
measure: Change in Psychosocial Functioning as Measured by Depression Severity Scale
time frame: Baseline, Month 4, Month 7
description: As measured by a 20-item Center for Epidemiologic Studies Depression (CES-D) scale. The possible range of scores are 0 to 60 with the higher scores indicating the presence of more symptomatology.
measure: Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)
time frame: Baseline, Month 4, Month 7
description: The SF-12v2 is a measure of health related quality of life and provides 2 scores 1) Mental Component Summary Score (MCS) and 2) Physical Component Summary Score (PCS). MCS scores range from 0 to 100, higher scores indicate better mental health related quality of life.
measure: Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)
time frame: Baseline, Month 4, Month 7
description: severity of depression will be measured by the 9-item PHQ-9. Scores range from 0 to 27. With scores of 1-4 indicating minimal depression and scores of 20-27 indicating severe depression.
measure: Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale
time frame: Baseline, Month 4, Month 7
description: The 7-item Generalized Anxiety Disorder (GAD-7) scale will be used to measure the severity of anxiety. The scores range from 0 to 21 with scores of 0 to 5 indicating mild anxiety and scores of 15-21 indicating severe anxiety.
measure: Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale
time frame: Baseline, Month 4, Month 7
description: The 14 item Healthy Families Program Perceived Stress Scale will be used to measure the severity of anxiety. PSS scores can range from 0 to 40 with higher scores indicated higher perception of stress.
measure: Change in Psychosocial Functioning as Measured by the Social Support Received
time frame: Baseline, Month 4, Month 7
description: The 12 item Multidimensional Scale of Perceived Social support. After calculating the mean score across the categories a mean scale support score from 1 to 2.9 would indicate low support, whereas a mean score of 5.1 to 7 would indicate high support.
measure: Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides
time frame: Baseline, Month 4, Month 7
description: A total cholesterol value of less than 200 mg/dL (5.18 mmol/L) is desirable and 240 mg/dL (6.22 mmol/L) or higher is high. Average HDL-C level is 40-50 mg/dL (1.0-1.3 mmol/L) for men. Low HDL-C level, increased risk, is less than 40 mg/dL (1.0 mmol/L). Optimal LDL-C levels are less than 100 mg/d while high levels are 160-189 mg/dL (4.15-4.90 mmol/L). Desirable triglyceride levels are less than 150 mg/dL (1.70 mmol/L) while high levels are considered 200-499 mg/dL (2.3-5.6 mmol/L).
measure: Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.
time frame: Baseline, Month 4, Month 7
description: Normal systolic and diastolic pressure is less than 120 mmHg and 80mmHg, respectively. High systolic and diastolic pressure is 140 mmHg or higher and 90 mmHg or higher, respectively.
measure: Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)
time frame: Baseline, Month 4, Month 7
description: The normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean a higher chance of getting diabetes. Levels of 6.5% or higher mean diabetes.
arm group label: Happy Older Latinos are Active (HOLA)
arm group type: Experimental
description: A 16-week multi-component, health promotion intervention
intervention type: Behavioral
intervention name: HOLA Component 1
description: At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.
arm group label: Happy Older Latinos are Active (HOLA)
intervention type: Behavioral
intervention name: HOLA Component 2
description: A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.
arm group label: Happy Older Latinos are Active (HOLA)
intervention type: Behavioral
intervention name: HOLA Component 3
description: A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.
arm group label: Happy Older Latinos are Active (HOLA)
intervention type: Behavioral
intervention name: HOLA Component 4
description: One booster walking session twice a month for three months post intervention for reinforcement.
arm group label: Happy Older Latinos are Active (HOLA)
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Jimenez, Ph.D.
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Daniel Enrique Jimenez
investigator title: Associate Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: All clinical research activities at the University of Miami were suspended due to the Coronavirus Disease of 2019 (COVID-19) pandemic. As a result, data collection and participant retention were impacted.
point of contact: 