xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06034457</url>
    </required_header>
    <id_info>
      <org_study_id>23-814</org_study_id>
      <nct_id>NCT06034457</nct_id>
    </id_info>
    <brief_title>Testing the Effectiveness of WW + Sequence GLP1 (WW+Sequence)</brief_title>
    <acronym>WW+Sequence</acronym>
    <official_title>24 Week External Single-arm Study Testing the Effectiveness of WW + Sequence GLP1 Medical Weight Management on Weight Loss and Related Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Cleveland Clinic</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study objective is to evaluate the efficacy of the WeightWatchers (WW) GLP1 behavioral&#xD;
        program + Sequence GLP1 Medical Weight Management program on weight loss and related&#xD;
        outcomes. Participants will be invited to take part and answer surveys at 0, 12 and 24 weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a 24 week prospective single-arm efficacy outcomes study. Up to 180 adult&#xD;
        participants who are currently enrolled in WW GLP1 behavioral program program + Sequence&#xD;
        Medical Weight Management program and already prescribed semaglutide or tirzepatide. The&#xD;
        application of a comprehensive lifestyle-based intervention focused on dietary intake,&#xD;
        physical activity, support and behavioral principles in conjunction with anti-obesity&#xD;
        medication (AOM) is novel and may increase AOM efficacy while minimizing maintenance&#xD;
        concerns. As obesity care can now be delivered virtually, it will also include an innovative&#xD;
        strategy of virtual/remotely delivered medical care (Sequence for Medical Weight Management)&#xD;
        and WW. Further, this study will examine multiple psychosocial domains associated with weight&#xD;
        loss and weight loss related outcomes including physical activity, dietary behavior,&#xD;
        disordered eating, depression symptoms, internalized weight bias and community, that have not&#xD;
        been examined in AOM trials.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">September 17, 2023</start_date>
    <completion_date type="Anticipated">September 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 17, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in weight in pounds from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW GLP1 behavioral program + Sequence on weight loss at 24 weeks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Weight loss percentage change from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on weight loss at 12 weeks and % reaching 5, 10, 15, 20 % body weight loss at 24 weeks.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Blood pressure changes (systolic and diastolic) in mmHg from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on blood pressure changes at 24 weeks</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Quality of Life scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Quality of Life (QOL) scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Well-being scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Well-being at 24 weeks</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Physical Activity scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Physical Activity at 24 weeks</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Diet Quality scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Diet Quality at 24 weeks</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Hunger scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Hunger scores at 24 weeks</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Stress scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Stress at 24 weeks</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Internalized Weight Bias scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Internalized Weight Bias</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Emotional Eating scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Emotional Eating scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Satisfaction scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Satisfaction scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Community scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Community scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Habit Strength scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Habit Strength scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Food Craving scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Food Craving scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Self-Compassion scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Self-Compassion scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Disordered Eating Behaviors scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Disordered Eating Behavior scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in reported GLP1 Side Effects from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Side Effects scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Restraint/Disinhibition scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Ristraint/Disinhibition scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Body Appreciation scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Body Appreciation scores</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in Depression symptom scores from week 0 to week 24</measure>
      <time_frame>0 to 24 weeks</time_frame>
      <description>Effect of WW + Sequence on Depression symptoms</description>
    </other_outcome>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Weight Loss</condition>
    <condition>Obesity</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will consist of patients who are already enrolled in the Sequence&#xD;
          Medical Weight Management program and prescribed GLP1 medications.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            1. 18 years or older&#xD;
  &#xD;
            2. BMI of &gt;30 or BMI of &gt;27 with one or more weight related medically qualifying&#xD;
               condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)&#xD;
  &#xD;
            3. Access to a smartphone with iOS&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Diabetes&#xD;
  &#xD;
            2. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine&#xD;
               Neoplasia type 2&#xD;
  &#xD;
            3. History of pancreatitis within 180 days&#xD;
  &#xD;
            4. Previous surgical obesity treatment&#xD;
  &#xD;
            5. Use of other anti-obesity medication in last 90 days&#xD;
  &#xD;
            6. Use of GLP1 within the last 180 days&#xD;
  &#xD;
            7. Lost weight &gt;11 lbs in the last 90 days&#xD;
  &#xD;
            8. Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and&#xD;
               not using a highly effective contraceptive method&#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>Amy DiVita</last_name>
      <role>Study Director</role>
      <affiliation>The Cleveland Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Cleveland Clinic</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>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
      <investigator_full_name>leslie heinberg</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Weight Loss</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06034457
  org study id: 23-814
  nct id: NCT06034457
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study objective is to evaluate the efficacy of the WeightWatchers (WW) GLP1 behavioral
        program + Sequence GLP1 Medical Weight Management program on weight loss and related
        outcomes. Participants will be invited to take part and answer surveys at 0, 12 and 24 weeks.
  This is a 24 week prospective single-arm efficacy outcomes study. Up to 180 adult
        participants who are currently enrolled in WW GLP1 behavioral program program + Sequence
        Medical Weight Management program and already prescribed semaglutide or tirzepatide. The
        application of a comprehensive lifestyle-based intervention focused on dietary intake,
        physical activity, support and behavioral principles in conjunction with anti-obesity
        medication (AOM) is novel and may increase AOM efficacy while minimizing maintenance
        concerns. As obesity care can now be delivered virtually, it will also include an innovative
        strategy of virtual/remotely delivered medical care (Sequence for Medical Weight Management)
        and WW. Further, this study will examine multiple psychosocial domains associated with weight
        loss and weight loss related outcomes including physical activity, dietary behavior,
        disordered eating, depression symptoms, internalized weight bias and community, that have not
        been examined in AOM trials.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in weight in pounds from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW GLP1 behavioral program + Sequence on weight loss at 24 weeks.
  measure: Weight loss percentage change from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on weight loss at 12 weeks and % reaching 5, 10, 15, 20 % body weight loss at 24 weeks.
  measure: Blood pressure changes (systolic and diastolic) in mmHg from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on blood pressure changes at 24 weeks
  measure: Change in Quality of Life scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Quality of Life (QOL) scores
  measure: Changes in Well-being scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Well-being at 24 weeks
  measure: Changes in Physical Activity scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Physical Activity at 24 weeks
  measure: Changes in Diet Quality scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Diet Quality at 24 weeks
  measure: Changes in Hunger scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Hunger scores at 24 weeks
  measure: Changes in Stress scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Stress at 24 weeks
  measure: Changes in Internalized Weight Bias scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Internalized Weight Bias
  measure: Changes in Emotional Eating scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Emotional Eating scores
  measure: Changes in Satisfaction scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Satisfaction scores
  measure: Changes in Community scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Community scores
  measure: Changes in Habit Strength scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Habit Strength scores
  measure: Changes in Food Craving scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Food Craving scores
  measure: Changes in Self-Compassion scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Self-Compassion scores
  measure: Changes in Disordered Eating Behaviors scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Disordered Eating Behavior scores
  measure: Changes in reported GLP1 Side Effects from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Side Effects scores
  measure: Changes in Restraint/Disinhibition scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Ristraint/Disinhibition scores
  measure: Changes in Body Appreciation scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Body Appreciation scores
  measure: Changes in Depression symptom scores from week 0 to week 24
  time frame: 0 to 24 weeks
  description: Effect of WW + Sequence on Depression symptoms
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amy DiVita
  role: Study Director
  affiliation: The Cleveland Clinic
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The Cleveland Clinic
  investigator full name: leslie heinberg
  investigator title: Professor
  mesh term: Weight Loss
  sharing ipd: No