<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/NCT03009825</url>
  </required_header>
  <id_info>
    <org_study_id>EA4057-troma</org_study_id>
    <nct_id>NCT03009825</nct_id>
  </id_info>
  <brief_title>Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients</brief_title>
  <acronym>TrOma</acronym>
  <official_title>TrOma: A Cross-sectional Study Investigating Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Paris 5 - Rene Descartes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Georges Pompidou Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Paris 5 - Rene Descartes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the associations between lifetime exposure to&#xD;
      traumatic events, emotion regulation strategies, and eating pathology of patients with&#xD;
      obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported binge eating pathology (BES)</measure>
    <time_frame>Baseline</time_frame>
    <description>Binge Eating Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported anxiety and depression (HADS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported mindfulness skills (FFMQ)</measure>
    <time_frame>Baseline</time_frame>
    <description>Five Facets Mindfulness Questionnaire (version: 15 items): observe, describe, act with awareness, non-judgment, non-react</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported emotion regulation (CERQ)</measure>
    <time_frame>Baseline</time_frame>
    <description>Cognitive Emotional Regulation Questionnaire (2 subscales): adaptive regulation and non-adaptive regulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported eating patterns (TFEQ-R18)</measure>
    <time_frame>Baseline</time_frame>
    <description>Three Factor Eating Questionnaire (3 subscales): emotional eating, uncontrolled eating, restraint eating</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported impact of traumatic event (IES-R)</measure>
    <time_frame>Baseline</time_frame>
    <description>Impact of Event Scale revised version (3 subscales): avoidance, intrusion, hyperarousal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported childhood trauma (CTQ)</measure>
    <time_frame>Baseline</time_frame>
    <description>Childhood Trauma Questionnaire (5 subscales): emotional neglect, emotional abuse, physical neglect, physical abuse, sexual abuse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported lifetime traumatic events (LEC-5)</measure>
    <time_frame>Baseline</time_frame>
    <description>Life Event Checklist (DSM-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (kg/m2)</measure>
    <time_frame>Baseline</time_frame>
    <description>BMI as measured by a physician</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sociodemographics and medical data</measure>
    <time_frame>Baseline</time_frame>
    <description>Form filled out by the participants</description>
  </other_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with obesity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults&#xD;
&#xD;
          -  Obese (BMI &gt;= 30)&#xD;
&#xD;
          -  Recruited from the nutrition service of Hôpital Européen Georges-Pompidou&#xD;
&#xD;
          -  Informed consent provided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PTSD symptoms (score &gt; 33 ; PTSD Checklist-5)&#xD;
&#xD;
          -  Bariatric surgery patients&#xD;
&#xD;
          -  Difficulties to understand French language&#xD;
&#xD;
          -  Patients under social protection&#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>Cécile Flahault, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Paris 5 - Rene Descartes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sébastien Czernichow, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Paris 5 - Rene Descartes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 22, 2018</last_update_submitted>
  <last_update_submitted_qc>December 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Paris 5 - Rene Descartes</investigator_affiliation>
    <investigator_full_name>Ruffault Alexis</investigator_full_name>
    <investigator_title>Doctoral candidate</investigator_title>
  </responsible_party>
  <keyword>Trauma exposure</keyword>
  <keyword>Psychological distress</keyword>
  <keyword>Emotion regulation</keyword>
  <keyword>Mindfulness</keyword>
  <keyword>Eating pathology</keyword>
  <!-- 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/NCT03009825
org study id: EA4057-troma
nct id: NCT03009825
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the associations between lifetime exposure to
      traumatic events, emotion regulation strategies, and eating pathology of patients with
      obesity.
observational model: Cohort
time perspective: Cross-Sectional
measure: Self-reported binge eating pathology (BES)
time frame: Baseline
description: Binge Eating Scale
measure: Self-reported anxiety and depression (HADS)
time frame: Baseline
description: Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression
measure: Self-reported mindfulness skills (FFMQ)
time frame: Baseline
description: Five Facets Mindfulness Questionnaire (version: 15 items): observe, describe, act with awareness, non-judgment, non-react
measure: Self-reported emotion regulation (CERQ)
time frame: Baseline
description: Cognitive Emotional Regulation Questionnaire (2 subscales): adaptive regulation and non-adaptive regulation
measure: Self-reported eating patterns (TFEQ-R18)
time frame: Baseline
description: Three Factor Eating Questionnaire (3 subscales): emotional eating, uncontrolled eating, restraint eating
measure: Self-reported impact of traumatic event (IES-R)
time frame: Baseline
description: Impact of Event Scale revised version (3 subscales): avoidance, intrusion, hyperarousal
measure: Self-reported childhood trauma (CTQ)
time frame: Baseline
description: Childhood Trauma Questionnaire (5 subscales): emotional neglect, emotional abuse, physical neglect, physical abuse, sexual abuse
measure: Self-reported lifetime traumatic events (LEC-5)
time frame: Baseline
description: Life Event Checklist (DSM-5)
measure: Body Mass Index (kg/m2)
time frame: Baseline
description: BMI as measured by a physician
measure: Sociodemographics and medical data
time frame: Baseline
description: Form filled out by the participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cécile Flahault, PhD
role: Study Director
affiliation: University Paris 5 - Rene Descartes
last name: Sébastien Czernichow, Pr
role: Principal Investigator
affiliation: University Paris 5 - Rene Descartes
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University of Paris 5 - Rene Descartes
investigator full name: Ruffault Alexis
investigator title: Doctoral candidate