<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/NCT03777189</url>
  </required_header>
  <id_info>
    <org_study_id>2000023412</org_study_id>
    <nct_id>NCT03777189</nct_id>
  </id_info>
  <brief_title>Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight</brief_title>
  <official_title>Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale 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>
      This study aims to perform an open-series pilot trial to examine the efficacy of&#xD;
      cognitive-behavioral therapy delivered in a guided self-help format (CBTgsh) with added&#xD;
      content related to physical activity (PA), for the treatment of binge-eating disorder (BED),&#xD;
      operationalized as BED full diagnostic criteria or BED with the full criteria except for the&#xD;
      binge episode size criterion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    benefits of treatment less than expected&#xD;
  </why_stopped>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">June 3, 2019</completion_date>
  <primary_completion_date type="Actual">June 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Binge-eating frequency</measure>
    <time_frame>Post-treatment (4 months)</time_frame>
    <description>Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index</measure>
    <time_frame>Post-treatment (4 months)</time_frame>
    <description>BMI is calculated using measured height and weight (e.g., percent loss)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Binge-Eating Disorder</condition>
  <condition>Binge Eating</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Cognitive-Behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-Behavioral Therapy</intervention_name>
    <description>Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.</description>
    <arm_group_label>Cognitive-Behavioral Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 to 65 years old;&#xD;
&#xD;
          2. Meet DSM-5 criteria for BED or BED but without the size criterion (LOC eating);&#xD;
&#xD;
          3. BMI 25-45 kg/m2;&#xD;
&#xD;
          4. Sedentary activity pattern (&lt; 90 mins/week of moderate-to-vigorous intensity&#xD;
             recreational physical activity);&#xD;
&#xD;
          5. Available for the duration of the treatment and follow-up (7 months);&#xD;
&#xD;
          6. Read, comprehend, and write English at a sufficient level to complete study-related&#xD;
             materials.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Co-existing psychiatric condition that requires hospitalization or more intensive&#xD;
             treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression).&#xD;
&#xD;
          2. Reports active suicidal or homicidal ideation.&#xD;
&#xD;
          3. Current anorexia or bulimia nervosa.&#xD;
&#xD;
          4. Contraindications to physical activity.&#xD;
&#xD;
          5. Blood pressure &gt;140 systolic or &gt;90 diastolic.&#xD;
&#xD;
          6. Breast-feeding or pregnant, or planning to become pregnant during the study.&#xD;
&#xD;
          7. History of stroke or myocardial infarction.&#xD;
&#xD;
          8. Current or recent (within 12 months) drug or alcohol dependence&#xD;
&#xD;
          9. Currently receiving effective treatment for eating or weight loss.&#xD;
&#xD;
         10. Currently participating in another clinical study.&#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 Grilo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>October 9, 2019</last_update_submitted>
  <last_update_submitted_qc>October 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</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>Bulimia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
    <mesh_term>Binge-Eating Disorder</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/NCT03777189
org study id: 2000023412
nct id: NCT03777189
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to perform an open-series pilot trial to examine the efficacy of
      cognitive-behavioral therapy delivered in a guided self-help format (CBTgsh) with added
      content related to physical activity (PA), for the treatment of binge-eating disorder (BED),
      operationalized as BED full diagnostic criteria or BED with the full criteria except for the
      binge episode size criterion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Binge-eating frequency
time frame: Post-treatment (4 months)
description: Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
measure: Body mass index
time frame: Post-treatment (4 months)
description: BMI is calculated using measured height and weight (e.g., percent loss)
arm group label: Cognitive-Behavioral Therapy
arm group type: Experimental
description: Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.
intervention type: Behavioral
intervention name: Cognitive-Behavioral Therapy
description: Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.
arm group label: Cognitive-Behavioral Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Carlos Grilo
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
mesh term: Bulimia
mesh term: Feeding and Eating Disorders
mesh term: Binge-Eating Disorder