<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/NCT02259322</url>
  </required_header>
  <id_info>
    <org_study_id>1205010224</org_study_id>
    <secondary_id>R01DK098492-01A1</secondary_id>
    <nct_id>NCT02259322</nct_id>
  </id_info>
  <brief_title>Loss of Control Eating Following Weight Loss Surgery</brief_title>
  <official_title>Treatment of Loss of Control Eating Following Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <brief_summary>
    <textblock>
      This study will test the effectiveness of two distinct behavioral treatments for loss of&#xD;
      control eating following bariatric surgery:&#xD;
&#xD;
        1. Behavioral Weight Loss Treatment&#xD;
&#xD;
        2. Cognitive Behavioral Therapy&#xD;
&#xD;
      These treatments will be compared to Standard-of-Care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Loss of Control Eating Frequency (Categorical)</measure>
    <time_frame>Post-treatment (at 3 months)</time_frame>
    <description>Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Loss of Control Eating Frequency (Categorical)</measure>
    <time_frame>24 month follow-up (an average of 24 months following treatment)</time_frame>
    <description>Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Loss of Control Eating Frequency (Continuous)</measure>
    <time_frame>Post-treatment (at 3 months)</time_frame>
    <description>Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Loss of Control Eating Frequency (Continuous)</measure>
    <time_frame>24 month follow-up (an average of 24 months following treatment)</time_frame>
    <description>Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Post-treatment (at 3 months)</time_frame>
    <description>BMI is calculated using measured height and weight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>24 month follow-up (an average of 24 months following treatment)</time_frame>
    <description>BMI is calculated using measured height and weight.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Loss of Control Eating</condition>
  <arm_group>
    <arm_group_label>Standard-of-Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral Weight Loss Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Guided self-help Behavioral Weight Loss Treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Guided self-help Cognitive Behavioral Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard-of-Care</intervention_name>
    <description>Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team.</description>
    <arm_group_label>Standard-of-Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Weight Loss Treatment</intervention_name>
    <description>Biweekly individual guided self-help sessions for 3 months</description>
    <arm_group_label>Behavioral Weight Loss Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy</intervention_name>
    <description>Biweekly individual guided self-help sessions for 3 months</description>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gastric bypass surgery or sleeve gastrectomy patients from Yale&#xD;
             Bariatric/Gastrointestinal Surgery Program&#xD;
&#xD;
          -  5-8 months post-bariatric surgery&#xD;
&#xD;
          -  Regular loss of control eating (once weekly during past month)&#xD;
&#xD;
          -  Read English proficiently enough to read patient self-care materials and study&#xD;
             assessments&#xD;
&#xD;
          -  Available for duration of treatment plus follow-up period&#xD;
&#xD;
          -  Agree to study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current enrollment in a formal exercise program&#xD;
&#xD;
          -  Medical status judged by the surgeon as contraindication (rare instances of need for&#xD;
             additional surgery or medical instability)&#xD;
&#xD;
          -  Unable to ambulate&#xD;
&#xD;
          -  Current medications that influence eating/weight&#xD;
&#xD;
          -  Current substance dependence or other severe psychiatric disturbance (e.g.,&#xD;
             suicidality) that requires immediate treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos M Grilo, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University School of Medicine; Department of Psychiatry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Department of Psychiatry</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>August 11, 2022</last_update_submitted>
  <last_update_submitted_qc>August 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bariatric surgery</keyword>
  <keyword>Weight loss surgery</keyword>
  <keyword>Behavioral weight loss treatment</keyword>
  <keyword>Cognitive behavioral therapy</keyword>
  <keyword>Behavioral treatment</keyword>
  <keyword>Obesity</keyword>
  <keyword>Morbid obesity</keyword>
  <keyword>Binge eating</keyword>
  <keyword>Binge eating disorder</keyword>
  <keyword>Loss of control eating</keyword>
  <keyword>Overeating</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02259322
org study id: 1205010224
secondary id: R01DK098492-01A1
nct id: NCT02259322
lead sponsor: 
collaborator: 
This study will test the effectiveness of two distinct behavioral treatments for loss of
      control eating following bariatric surgery:

        1. Behavioral Weight Loss Treatment

        2. Cognitive Behavioral Therapy

      These treatments will be compared to Standard-of-Care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Loss of Control Eating Frequency (Categorical)
time frame: Post-treatment (at 3 months)
description: Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating).
measure: Loss of Control Eating Frequency (Categorical)
time frame: 24 month follow-up (an average of 24 months following treatment)
description: Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating).
measure: Loss of Control Eating Frequency (Continuous)
time frame: Post-treatment (at 3 months)
description: Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
measure: Loss of Control Eating Frequency (Continuous)
time frame: 24 month follow-up (an average of 24 months following treatment)
description: Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
measure: Body Mass Index (BMI)
time frame: Post-treatment (at 3 months)
description: BMI is calculated using measured height and weight.
measure: Body Mass Index (BMI)
time frame: 24 month follow-up (an average of 24 months following treatment)
description: BMI is calculated using measured height and weight.
arm group label: Standard-of-Care
arm group type: Active Comparator
description: Standard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team.
arm group label: Behavioral Weight Loss Treatment
arm group type: Experimental
description: Guided self-help Behavioral Weight Loss Treatment
arm group label: Cognitive Behavioral Therapy
arm group type: Experimental
description: Guided self-help Cognitive Behavioral Therapy
intervention type: Behavioral
intervention name: Standard-of-Care
description: Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team.
arm group label: Standard-of-Care
intervention type: Behavioral
intervention name: Behavioral Weight Loss Treatment
description: Biweekly individual guided self-help sessions for 3 months
arm group label: Behavioral Weight Loss Treatment
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy
description: Biweekly individual guided self-help sessions for 3 months
arm group label: Cognitive Behavioral Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Carlos M Grilo, Ph.D.
role: Principal Investigator
affiliation: Yale University School of Medicine; Department of Psychiatry
facility: 
country: United States
responsible party type: Sponsor
mesh term: Weight Loss