<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/NCT04492189</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0220</org_study_id>
    <nct_id>NCT04492189</nct_id>
  </id_info>
  <brief_title>Containment Measures and Eating Disorders</brief_title>
  <acronym>COVITA</acronym>
  <official_title>Impact of Containment Measures in People With Eating Disorders: a Descriptive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>INSERM U1061 (Statistics)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Since March 17, 2020, the French government has implemented national containment measures due&#xD;
      to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives,&#xD;
      loss of liberty, concern about the infectious status, boredom, can negatively affect mental&#xD;
      health, with the emergence of anxiety and depressive symptoms.&#xD;
&#xD;
      In addition, confinement can disrupt usual physical activity, a major destabilization&#xD;
      criterion for patients suffering from eating disorders (ED). Finally, conditions of&#xD;
      confinement can harm social support, yet identified as a protective and resilience factor in&#xD;
      stress contexts. Thus, the current context of confinement and social distances could be&#xD;
      source of an increase in eating behavior disorders symptoms in people suffering from ED.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will recruit 40 patients with eating disorders. All patients were initially&#xD;
      assessed in the daily hospital of the Endocrinology, Diabetes, Nutrition Department&#xD;
      (Montpellier University Hospital) from January to march 2020.&#xD;
&#xD;
      All participants will performed a phone interview to assess eating disorder symptoms,&#xD;
      caracteristicus of containment, 1 month after the beginning of the containment, and 1 month&#xD;
      after the end of the containment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Variation in eating disorders</measure>
    <time_frame>1 month</time_frame>
    <description>the investigators aim to investigate the link between containment measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation in eating disorders</measure>
    <time_frame>1 month</time_frame>
    <description>the investigators aim to investigate the link between ED symptomatology with EDE-Q (eating disorder evaluation, caractéristiques du TCA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vision of the bodily aspect</measure>
    <time_frame>1 month</time_frame>
    <description>The investigators aim to investigate the link between containment measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vision of the bodily aspect</measure>
    <time_frame>1 month</time_frame>
    <description>The investigators aim to investigate the link between body dissatisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in physical activity</measure>
    <time_frame>1 month</time_frame>
    <description>the investigators aim to investigate the link between containment measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in physical activity</measure>
    <time_frame>1 month</time_frame>
    <description>the investigators aim to investigate the link between physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify the clinical factors modulating the psychological state during confinement</measure>
    <time_frame>1 month</time_frame>
    <description>the investigators aim to investigate the link between containment measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify the clinical factors modulating the psychological state during confinement</measure>
    <time_frame>1 month</time_frame>
    <description>the investigators aim to investigate the link between emotional eating</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Eating Disorders</condition>
  <condition>COVID 19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients are adult women with a diagnostic of ED&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adult women&#xD;
&#xD;
          -  Surferring from ED&#xD;
&#xD;
          -  Assessed in the ED daily hospital (UH of Montpellier) from January to March 2020&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  minors&#xD;
&#xD;
          -  refusal to participate&#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>Ariane SULTAN, PR</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</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>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </patient_data>
  <!-- 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/NCT04492189
org study id: RECHMPL20_0220
nct id: NCT04492189
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since March 17, 2020, the French government has implemented national containment measures due
      to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives,
      loss of liberty, concern about the infectious status, boredom, can negatively affect mental
      health, with the emergence of anxiety and depressive symptoms.

      In addition, confinement can disrupt usual physical activity, a major destabilization
      criterion for patients suffering from eating disorders (ED). Finally, conditions of
      confinement can harm social support, yet identified as a protective and resilience factor in
      stress contexts. Thus, the current context of confinement and social distances could be
      source of an increase in eating behavior disorders symptoms in people suffering from ED.
Investigators will recruit 40 patients with eating disorders. All patients were initially
      assessed in the daily hospital of the Endocrinology, Diabetes, Nutrition Department
      (Montpellier University Hospital) from January to march 2020.

      All participants will performed a phone interview to assess eating disorder symptoms,
      caracteristicus of containment, 1 month after the beginning of the containment, and 1 month
      after the end of the containment.
observational model: Other
time perspective: Prospective
measure: Variation in eating disorders
time frame: 1 month
description: the investigators aim to investigate the link between containment measures
measure: Variation in eating disorders
time frame: 1 month
description: the investigators aim to investigate the link between ED symptomatology with EDE-Q (eating disorder evaluation, caractéristiques du TCA)
measure: Vision of the bodily aspect
time frame: 1 month
description: The investigators aim to investigate the link between containment measures
measure: Vision of the bodily aspect
time frame: 1 month
description: The investigators aim to investigate the link between body dissatisfaction
measure: Variation in physical activity
time frame: 1 month
description: the investigators aim to investigate the link between containment measures
measure: Variation in physical activity
time frame: 1 month
description: the investigators aim to investigate the link between physical activity
measure: Identify the clinical factors modulating the psychological state during confinement
time frame: 1 month
description: the investigators aim to investigate the link between containment measures
measure: Identify the clinical factors modulating the psychological state during confinement
time frame: 1 month
description: the investigators aim to investigate the link between emotional eating
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ariane SULTAN, PR
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Feeding and Eating Disorders
sharing ipd: Undecided
ipd description: NC