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/NCT05987306</url>
    </required_header>
    <id_info>
      <org_study_id>UMCIRB 23-001492</org_study_id>
      <nct_id>NCT05987306</nct_id>
    </id_info>
    <brief_title>A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss</brief_title>
    <official_title>A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>East Carolina University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of South Alabama</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>East Carolina University</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 goal of clinical trial is to test a novel weight loss approach combining a standard&#xD;
        weight loss and internalized weight bias intervention with self-compassion exercises in&#xD;
        overweight adults with moderate to high levels of internalized weight bias. The main&#xD;
        question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2)&#xD;
        significantly reduce internalized weight bias. Participants will take part in a 12 week novel&#xD;
        weight loss approach combining a standard weight loss and internalized weight bias&#xD;
        intervention with self-compassion exercises using videoconferencing software.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of clinical trial is to test a novel weight loss approach combining a standard&#xD;
        weight loss and internalized weight bias intervention with self-compassion exercises in&#xD;
        overweight adults with moderate to high levels of internalized weight bias. The main&#xD;
        question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2)&#xD;
        significantly reduce internalized weight bias. Participants will take part in a 12-week novel&#xD;
        weight loss approach combining a standard weight loss and internalized weight bias&#xD;
        intervention with self-compassion exercises using videoconferencing software. The weight loss&#xD;
        approach will be modeled after the Diabetes Prevention Program and the approach utilized to&#xD;
        reduce internalized weight bias will be Kristen Neff's self-compassion intervention. Each&#xD;
        weekly session will utilize Webex videoconferencing software and last approximately 60-90&#xD;
        minutes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single group pre and posttest design.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Weight (lbs)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Change in weight or percent body weight</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Weight Bias Internalization Scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>Change in internalized weight bias</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Overweight and Obesity</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>a standard weight loss and internalized weight bias intervention with self-compassion exercises</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Weight loss plus self-compassion</intervention_name>
      <description>A novel weight loss approach combining a standard weight loss based on the Diabetes Prevention Program and internalized weight bias intervention with self-compassion exercises.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BMI ≥ 25, ≥ 18 years old, Smartphone access, WBIS score ≥ 4&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Type I diabetes, uncontrolled hypertension, cardiovascular event in past year, any&#xD;
               major active kidney, liver, cardio, or cerebrovascular disease, musculoskeletal&#xD;
               problems that would prevent physical activity, current weight loss medication or&#xD;
               weight loss program, history of bariatric surgery, pregnant or breastfeeding, eating&#xD;
               disorder except BED.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Robert Carels</last_name>
      <role>Principal Investigator</role>
      <affiliation>East Carolina University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Robert Carels</last_name>
      <phone>4193782704</phone>
      <email>carelsr14@ecu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Abbie Metzler</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>East Carolina University</name>
        <address>
          <city>Greenville</city>
          <state>North Carolina</state>
          <zip>27858</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Robert Carels, PhD</last_name>
        <phone>252-737-5070</phone>
        <email>carelsr14@ecu.edu</email>
      </contact>
      <contact_backup>
        <last_name>Abbie Metzler, BA</last_name>
        <phone>2527375070</phone>
        <email>metzlera23@students.ecu.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>Overweight</mesh_term>
      <mesh_term>Weight Loss</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>I am happy to make data available to qualified researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05987306
  org study id: UMCIRB 23-001492
  nct id: NCT05987306
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of clinical trial is to test a novel weight loss approach combining a standard
        weight loss and internalized weight bias intervention with self-compassion exercises in
        overweight adults with moderate to high levels of internalized weight bias. The main
        question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2)
        significantly reduce internalized weight bias. Participants will take part in a 12 week novel
        weight loss approach combining a standard weight loss and internalized weight bias
        intervention with self-compassion exercises using videoconferencing software.
  The goal of clinical trial is to test a novel weight loss approach combining a standard
        weight loss and internalized weight bias intervention with self-compassion exercises in
        overweight adults with moderate to high levels of internalized weight bias. The main
        question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2)
        significantly reduce internalized weight bias. Participants will take part in a 12-week novel
        weight loss approach combining a standard weight loss and internalized weight bias
        intervention with self-compassion exercises using videoconferencing software. The weight loss
        approach will be modeled after the Diabetes Prevention Program and the approach utilized to
        reduce internalized weight bias will be Kristen Neff's self-compassion intervention. Each
        weekly session will utilize Webex videoconferencing software and last approximately 60-90
        minutes.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single group pre and posttest design.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Weight (lbs)
  time frame: 12 weeks
  description: Change in weight or percent body weight
  measure: Weight Bias Internalization Scale
  time frame: 12 weeks
  description: Change in internalized weight bias
  arm group label: Intervention
  arm group type: Experimental
  description: a standard weight loss and internalized weight bias intervention with self-compassion exercises
  intervention type: Behavioral
  intervention name: Weight loss plus self-compassion
  description: A novel weight loss approach combining a standard weight loss based on the Diabetes Prevention Program and internalized weight bias intervention with self-compassion exercises.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Robert Carels
  role: Principal Investigator
  affiliation: East Carolina University
  last name: Robert Carels
  phone: 4193782704
  email: carelsr14@ecu.edu
  last name: Abbie Metzler
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Overweight
  mesh term: Weight Loss
  sharing ipd: Yes
  ipd description: I am happy to make data available to qualified researchers.