<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/NCT03799198</url>
  </required_header>
  <id_info>
    <org_study_id>NN8022-4432</org_study_id>
    <secondary_id>U1111-1218-8104</secondary_id>
    <nct_id>NCT03799198</nct_id>
  </id_info>
  <brief_title>Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity</brief_title>
  <official_title>Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity - a Pragmatic Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers are doing this study to compare the effects of drugs approved for long-term&#xD;
      weight loss combined with an employer-based weight management program with the effects of the&#xD;
      weight management program without drugs for weight loss. If participants agree to be in this&#xD;
      study, they will join the Cleveland Clinic Integrated Medical Weight Management Program&#xD;
      (WMP). Participants will be assigned by chance (like flipping a coin) to one of two treatment&#xD;
      groups: A) Group 1: Cleveland Clinic Integrated Medical WMP + medication for long-term weight&#xD;
      loss. B) Group 2: Cleveland Clinic Integrated Medical WMP without medication for weight loss.&#xD;
      Participants have an equal chance of being in either of the treatment groups. The total study&#xD;
      duration for the individual participants will be approximately one year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">May 22, 2020</completion_date>
  <primary_completion_date type="Actual">May 22, 2020</primary_completion_date>
  <phase>Phase 4</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 Body Weight</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>Percentage change in body weight from baseline (month 0) to month 12 is presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participants Achieving 5% or More Reduction in Body Weight</measure>
    <time_frame>Month 12</time_frame>
    <description>The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Achieving 10% or More Reduction in Body Weight</measure>
    <time_frame>Month 12</time_frame>
    <description>The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Shared Medical Appointments (SMAs) Attended</measure>
    <time_frame>Months 0-12</time_frame>
    <description>Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Attending 9 or More SMAs</measure>
    <time_frame>Months 0-12</time_frame>
    <description>Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management</measure>
    <time_frame>Months 0-12</time_frame>
    <description>Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days</measure>
    <time_frame>Months 0-12</time_frame>
    <description>Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 'Time Management' as Measured by WLQ-8</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 'Physical Tasks' as Measured by WLQ-8</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 'Output Tasks' as Measured by WLQ-8</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP)</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP</measure>
    <time_frame>Month 0, month 12</time_frame>
    <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>WMP + Rx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately one year. After discussing with the study doctor, participants will receive one of the following listed 5 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) lorcaserin or lorcaserin extended-release, 3) phentermine/topiramate extended-release, 4) naltrexone/bupropion extended-release and 5) liraglutide 3.0 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WMP alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately one year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Weight Management Program (WMP)</intervention_name>
    <description>As part of usual care, participants will: 1) Discuss and choose one of three diet options: protein-sparing modified fast, Mediterranean, or meal replacement. 2) Be referred to a nutritionist appointment. 3) Initiate a series of twelve monthly study visits in the context of shared medical appointments (SMAs) covering nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress. 4) Be referred to an exercise physiologist for a personalized physical activity program. 5) If assessed relevant by the study clinician, be referred to a mental health specialist and/or sleep clinic.</description>
    <arm_group_label>WMP + Rx</arm_group_label>
    <arm_group_label>WMP alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medication for chronic weight management (Rx)</intervention_name>
    <description>Following listed 5 drugs will be administered as prescribed by the study doctor:&#xD;
1) Orlistat (Xenical® pills, per os [p.o.; by mouth]). 2) Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.). 3) Phentermine/topiramate extended-release (Qsymia® pills, p.o.). 4) Naltrexone/bupropion extended-release (Contrave® pills, p.o.). 5) Liraglutide 3.0 mg (Saxenda® injections, subcutaneously [under the skin]).</description>
    <arm_group_label>WMP + Rx</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any study-related activities. Study-related&#xD;
             activities are any procedures that are carried out as part of the study, including&#xD;
             activities to determine eligibility for the study&#xD;
&#xD;
          -  Male or female, age more than or equal to 18 years at the time of signing informed&#xD;
             consent&#xD;
&#xD;
          -  Body mass index (BMI) more than or equal 30 kg/m^2&#xD;
&#xD;
          -  Enrolled in Cleveland Clinic Employee Health Plan, and expecting to be covered by the&#xD;
             Cleveland Clinic Employee Health Plan for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to all of the medications approved by the FDA for chronic weight&#xD;
             management according to the label&#xD;
&#xD;
          -  Previous participation in this study. Participation is defined as signed informed&#xD;
             consent&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of&#xD;
             child-bearing potential and not using adequate contraceptive methods (adequate&#xD;
             contraceptive measures as required by local regulation or practice)&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days before screening&#xD;
&#xD;
          -  Treatment with any medication with the intention of weight loss within 90 days before&#xD;
             screening&#xD;
&#xD;
          -  Previous or current participation in Cleveland Clinic's Integrated Medical Weight&#xD;
             Management Program&#xD;
&#xD;
          -  History of (or plans during the study period for) bariatric surgery, or use of&#xD;
             minimally-invasive weight loss devices (i.e. Intragastric balloons, lap bands) not&#xD;
             removed within 1 year prior to screening&#xD;
&#xD;
          -  History of type 1 or type 2 diabetes mellitus&#xD;
&#xD;
          -  Hemoglobin A1c (HbA1c) more than or equal to 6.5% at screening or within 90 days prior&#xD;
             to randomization&#xD;
&#xD;
          -  Any condition, unwillingness or inability, not covered by any of the other exclusion&#xD;
             criteria, which, in the study clinician's opinion, might jeopardize the subject's&#xD;
             safety or compliance with the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Reporting Anchor and Disclosure (1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>May 6, 2021</results_first_submitted>
  <results_first_submitted_qc>June 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 18, 2021</results_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
    <ipd_url>http://www.novonordisk-trials.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03799198/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03799198/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at a single site in the United States.</recruitment_details>
      <pre_assignment_details>Participants were randomized in a 1:1 manner to receive either Cleveland Clinic's Integrated Medical Weight Management Program (WMP) with medication for chronic weight management (WMP + Rx) or Cleveland Clinic's Integrated Medical WMP alone (WMP).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Weight Management Program (WMP) + Rx</title>
          <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
        </group>
        <group group_id="P2">
          <title>Weight Management Program (WMP)</title>
          <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set (FAS)</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS) comprised of all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Weight Management Program (WMP) + Rx</title>
          <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
        </group>
        <group group_id="B2">
          <title>Weight Management Program (WMP)</title>
          <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="200"/>
          </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="51.0" spread="10.43"/>
                    <measurement group_id="B2" value="49.1" spread="10.11"/>
                    <measurement group_id="B3" value="50.0" spread="10.29"/>
                  </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="88"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </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="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian/White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>India</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Body Weight</title>
        <description>Percentage change in body weight from baseline (month 0) to month 12 is presented.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight</title>
          <description>Percentage change in body weight from baseline (month 0) to month 12 is presented.</description>
          <population>The FAS comprised of all randomized participants.</population>
          <units>Percent change of body weight</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.69" spread="0.72"/>
                    <measurement group_id="O2" value="-4.19" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Treatment Difference</param_type>
            <param_value>-3.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.02</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.51</ci_lower_limit>
            <ci_upper_limit>-1.50</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Achieving 5% or More Reduction in Body Weight</title>
        <description>The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented.</description>
        <time_frame>Month 12</time_frame>
        <population>The FAS comprised of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Achieving 5% or More Reduction in Body Weight</title>
          <description>The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented.</description>
          <population>The FAS comprised of all randomized participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5"/>
                    <measurement group_id="O2" value="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Achieving 10% or More Reduction in Body Weight</title>
        <description>The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented.</description>
        <time_frame>Month 12</time_frame>
        <population>The FAS comprised of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Achieving 10% or More Reduction in Body Weight</title>
          <description>The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented.</description>
          <population>The FAS comprised of all randomized participants.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7"/>
                    <measurement group_id="O2" value="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Shared Medical Appointments (SMAs) Attended</title>
        <description>Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented.</description>
        <time_frame>Months 0-12</time_frame>
        <population>The FAS comprised of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Shared Medical Appointments (SMAs) Attended</title>
          <description>Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented.</description>
          <population>The FAS comprised of all randomized participants.</population>
          <units>SMAs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" spread="2.98"/>
                    <measurement group_id="O2" value="7.4" spread="3.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Attending 9 or More SMAs</title>
        <description>Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented.</description>
        <time_frame>Months 0-12</time_frame>
        <population>The FAS comprised of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Attending 9 or More SMAs</title>
          <description>Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented.</description>
          <population>The FAS comprised of all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management</title>
        <description>Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx.</description>
        <time_frame>Months 0-12</time_frame>
        <population>The FAS comprised of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management</title>
          <description>Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx.</description>
          <population>The FAS comprised of all randomized participants.</population>
          <units>Proportion of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.48" spread="27.096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days</title>
        <description>Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx.</description>
        <time_frame>Months 0-12</time_frame>
        <population>The FAS comprised of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days</title>
          <description>Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx.</description>
          <population>The FAS comprised of all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)</title>
        <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)</title>
          <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented.</description>
          <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.06"/>
                    <measurement group_id="O2" value="-0.03" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 'Time Management' as Measured by WLQ-8</title>
        <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 'Time Management' as Measured by WLQ-8</title>
          <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented.</description>
          <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.07"/>
                    <measurement group_id="O2" value="-0.19" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 'Physical Tasks' as Measured by WLQ-8</title>
        <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 'Physical Tasks' as Measured by WLQ-8</title>
          <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented.</description>
          <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.11"/>
                    <measurement group_id="O2" value="-0.05" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8</title>
        <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8</title>
          <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented.</description>
          <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.09"/>
                    <measurement group_id="O2" value="-0.03" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 'Output Tasks' as Measured by WLQ-8</title>
        <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 'Output Tasks' as Measured by WLQ-8</title>
          <description>The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented.</description>
          <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.10"/>
                    <measurement group_id="O2" value="0.12" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP)</title>
        <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP)</title>
          <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
          <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="0.17"/>
                    <measurement group_id="O2" value="-0.48" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP</title>
        <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP</title>
          <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
          <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.88" spread="1.62"/>
                    <measurement group_id="O2" value="-1.94" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP</title>
        <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP</title>
          <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
          <population>The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.84" spread="1.62"/>
                    <measurement group_id="O2" value="-1.89" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP</title>
        <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
        <time_frame>Month 0, month 12</time_frame>
        <population>The FAS comprised of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Management Program (WMP) + Rx</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
          </group>
          <group group_id="O2">
            <title>Weight Management Program (WMP)</title>
            <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP</title>
          <description>The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.</description>
          <population>The FAS comprised of all randomized participants.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.95" spread="2.53"/>
                    <measurement group_id="O2" value="-7.20" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Months 0 - 12</time_frame>
      <desc>All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Weight Management Program (WMP) + Rx</title>
          <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.</description>
        </group>
        <group group_id="E2">
          <title>Weight Management Program (WMP)</title>
          <description>Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Plasma Cell Myeloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Atrial Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Congestive Cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Salmonella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Procedural Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Parathyroid Tumour Benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression Suicidal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian Mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Organ Donor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Gastric Bypass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Transparency and Medical Writing Office (1452)</name_or_title>
      <organization>Novo Nordisk A/S</organization>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.com</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/NCT03799198
org study id: NN8022-4432
secondary id: U1111-1218-8104
nct id: NCT03799198
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Researchers are doing this study to compare the effects of drugs approved for long-term
      weight loss combined with an employer-based weight management program with the effects of the
      weight management program without drugs for weight loss. If participants agree to be in this
      study, they will join the Cleveland Clinic Integrated Medical Weight Management Program
      (WMP). Participants will be assigned by chance (like flipping a coin) to one of two treatment
      groups: A) Group 1: Cleveland Clinic Integrated Medical WMP + medication for long-term weight
      loss. B) Group 2: Cleveland Clinic Integrated Medical WMP without medication for weight loss.
      Participants have an equal chance of being in either of the treatment groups. The total study
      duration for the individual participants will be approximately one year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Body Weight
time frame: Month 0, month 12
description: Percentage change in body weight from baseline (month 0) to month 12 is presented.
measure: Participants Achieving 5% or More Reduction in Body Weight
time frame: Month 12
description: The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented.
measure: Participants Achieving 10% or More Reduction in Body Weight
time frame: Month 12
description: The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented.
measure: Number of Shared Medical Appointments (SMAs) Attended
time frame: Months 0-12
description: Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented.
measure: Participants Attending 9 or More SMAs
time frame: Months 0-12
description: Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented.
measure: Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management
time frame: Months 0-12
description: Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx.
measure: Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days
time frame: Months 0-12
description: Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx.
measure: Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)
time frame: Month 0, month 12
description: The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented.
measure: Change in 'Time Management' as Measured by WLQ-8
time frame: Month 0, month 12
description: The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented.
measure: Change in 'Physical Tasks' as Measured by WLQ-8
time frame: Month 0, month 12
description: The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented.
measure: Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8
time frame: Month 0, month 12
description: The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented.
measure: Change in 'Output Tasks' as Measured by WLQ-8
time frame: Month 0, month 12
description: The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented.
measure: Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP)
time frame: Month 0, month 12
description: The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
measure: Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP
time frame: Month 0, month 12
description: The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
measure: Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP
time frame: Month 0, month 12
description: The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
measure: Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP
time frame: Month 0, month 12
description: The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
arm group label: WMP + Rx
arm group type: Experimental
description: Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately one year. After discussing with the study doctor, participants will receive one of the following listed 5 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) lorcaserin or lorcaserin extended-release, 3) phentermine/topiramate extended-release, 4) naltrexone/bupropion extended-release and 5) liraglutide 3.0 mg.
arm group label: WMP alone
arm group type: Active Comparator
description: Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately one year.
intervention type: Other
intervention name: Weight Management Program (WMP)
description: As part of usual care, participants will: 1) Discuss and choose one of three diet options: protein-sparing modified fast, Mediterranean, or meal replacement. 2) Be referred to a nutritionist appointment. 3) Initiate a series of twelve monthly study visits in the context of shared medical appointments (SMAs) covering nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress. 4) Be referred to an exercise physiologist for a personalized physical activity program. 5) If assessed relevant by the study clinician, be referred to a mental health specialist and/or sleep clinic.
arm group label: WMP + Rx
arm group label: WMP alone
intervention type: Drug
intervention name: Medication for chronic weight management (Rx)
description: Following listed 5 drugs will be administered as prescribed by the study doctor:
1) Orlistat (Xenical® pills, per os [p.o.; by mouth]). 2) Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.). 3) Phentermine/topiramate extended-release (Qsymia® pills, p.o.). 4) Naltrexone/bupropion extended-release (Contrave® pills, p.o.). 5) Liraglutide 3.0 mg (Saxenda® injections, subcutaneously [under the skin]).
arm group label: WMP + Rx
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure (1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: http://www.novonordisk-trials.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 