<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/NCT04431284</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0516</org_study_id>
    <secondary_id>2020-A01616-33</secondary_id>
    <nct_id>NCT04431284</nct_id>
  </id_info>
  <brief_title>Impact of COVID-19 Lockdown on Obesity and Eating Behaviors</brief_title>
  <acronym>CIO</acronym>
  <official_title>Impact of COVID-19 Lockdown on Severely Obese Patients With or Without Binge Eating Behaviors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      COVID-19 lockdown presents particular challenges for people living with obesity. Indeed&#xD;
      during this period, the lifestyle was deeply modified: diet, activity, and sleep behaviours,&#xD;
      home office, take care of child, social distancing... All of these modifications may have led&#xD;
      to stress and anxiety. It has been previously demonstrated that high perceived stress levels&#xD;
      are correlated with high preference for sweet and fat foods . In this context caution would&#xD;
      be exercised in obese patients especially those with binge eating disorders. Indeed binge&#xD;
      eating disorder is characterized by compulsive overeating or consuming abnormal amounts of&#xD;
      food while feeling unable to stop and a loss of control. And one key trigger of binge eating&#xD;
      disorder is stress and anxiety. Thus, patients with binge eating disorders may have been more&#xD;
      sensitive to the impact of lockdown and thus urgently would require appropriated care&#xD;
      management.&#xD;
&#xD;
      The main objective is to compare the eating behaviour between obese patients with or without&#xD;
      binge eating disorders. The second objective is to compare the weight evolution between the&#xD;
      two groups before and after the lockdown.&#xD;
&#xD;
      To reach these objectives, the scientific team of the CIO project proposes to contact by&#xD;
      phone and e-mail obese patients (with or without binge eating disorders) who have been&#xD;
      hospitalized for their obesity disease before the start of the lockdown in the Endocrinology&#xD;
      department of the Lyon Hospital. The patients will be asked to fill in several questionnaires&#xD;
      (using an online tool) allowing to evaluate their mood, anxiety, eating behaviour, binge&#xD;
      eating disorders… during the lockdown. The results of these questionnaires will be compared&#xD;
      to those collected during their hospitalisation before the lockdown.&#xD;
&#xD;
      The hypothesis is that participants suffering from binge eating disorder will have more sever&#xD;
      eating behaviour perturbations as higher level of stress, anxiety, depressive symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">December 16, 2020</completion_date>
  <primary_completion_date type="Actual">December 16, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the BMI (kg/m²) evolution between the two groups</measure>
    <time_frame>Day 21</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Score comparison of the Dutch Eating Behavior Questionnaire</measure>
    <time_frame>Day 21</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Feeding and Eating Disorders</condition>
  <arm_group>
    <arm_group_label>Obese patients with binge eating disorders</arm_group_label>
    <description>Severely obese patients (with or without binge eating disorders, Binge Eating Sclae &gt;= 16) who have been hospitalized for obesity assessment before the start of the lockdown in the Endocrinology department of the Lyon Hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese patients without binge eating disorders</arm_group_label>
    <description>Severely obese patients (with or without binge eating disorders, Binge Eating Sclae &gt;= 16) who have been hospitalized for obesity assessment before the start of the lockdown in the Endocrinology department of the Lyon Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>The two groups (23 patients per group) will be contacted by phone or e-mail to participate to the CIO study. Once their agreement received, each patient will be asked to complete the same set of online questionnaires : weight, HAD (Hospital Anxiety and Depression scale), BES (Binge Eating Scale), YFAS (Yale Food Addiction Scale), DEBQ (Dutch Eating Behavior Questionnaire), IPAQ (International physical activity questionnaire), COVID 19 questionnaire Penn State, items from the Do-It questionnaire, general questions on the lifestyle during the lockdown (custom questionnaire), COVID stress evaluation (custom questionnaire)</description>
    <arm_group_label>Obese patients with binge eating disorders</arm_group_label>
    <arm_group_label>Obese patients without binge eating disorders</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Obese patients with or without binge eating disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  severely obese patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients do not experiment the full lockdown period&#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>Emmanuel DISSE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Intégré de l'obésité de Lyon / HCL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martine LAVILLE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Intégré de l'obésité de Lyon / HCL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Intégré de l'obésité de Lyon / HCL</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Torres SJ, Nowson CA. Relationship between stress, eating behavior, and obesity. Nutrition. 2007 Nov-Dec;23(11-12):887-94. doi: 10.1016/j.nut.2007.08.008. Epub 2007 Sep 17.</citation>
    <PMID>17869482</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 29, 2021</last_update_submitted>
  <last_update_submitted_qc>January 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</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>
  <!-- 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/NCT04431284
org study id: 69HCL20_0516
secondary id: 2020-A01616-33
nct id: NCT04431284
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
COVID-19 lockdown presents particular challenges for people living with obesity. Indeed
      during this period, the lifestyle was deeply modified: diet, activity, and sleep behaviours,
      home office, take care of child, social distancing... All of these modifications may have led
      to stress and anxiety. It has been previously demonstrated that high perceived stress levels
      are correlated with high preference for sweet and fat foods . In this context caution would
      be exercised in obese patients especially those with binge eating disorders. Indeed binge
      eating disorder is characterized by compulsive overeating or consuming abnormal amounts of
      food while feeling unable to stop and a loss of control. And one key trigger of binge eating
      disorder is stress and anxiety. Thus, patients with binge eating disorders may have been more
      sensitive to the impact of lockdown and thus urgently would require appropriated care
      management.

      The main objective is to compare the eating behaviour between obese patients with or without
      binge eating disorders. The second objective is to compare the weight evolution between the
      two groups before and after the lockdown.

      To reach these objectives, the scientific team of the CIO project proposes to contact by
      phone and e-mail obese patients (with or without binge eating disorders) who have been
      hospitalized for their obesity disease before the start of the lockdown in the Endocrinology
      department of the Lyon Hospital. The patients will be asked to fill in several questionnaires
      (using an online tool) allowing to evaluate their mood, anxiety, eating behaviour, binge
      eating disorders… during the lockdown. The results of these questionnaires will be compared
      to those collected during their hospitalisation before the lockdown.

      The hypothesis is that participants suffering from binge eating disorder will have more sever
      eating behaviour perturbations as higher level of stress, anxiety, depressive symptoms.
observational model: Other
time perspective: Retrospective
measure: Comparison of the BMI (kg/m²) evolution between the two groups
time frame: Day 21
measure: Score comparison of the Dutch Eating Behavior Questionnaire
time frame: Day 21
arm group label: Obese patients with binge eating disorders
description: Severely obese patients (with or without binge eating disorders, Binge Eating Sclae >= 16) who have been hospitalized for obesity assessment before the start of the lockdown in the Endocrinology department of the Lyon Hospital
arm group label: Obese patients without binge eating disorders
description: Severely obese patients (with or without binge eating disorders, Binge Eating Sclae >= 16) who have been hospitalized for obesity assessment before the start of the lockdown in the Endocrinology department of the Lyon Hospital
intervention type: Other
intervention name: Questionnaires
description: The two groups (23 patients per group) will be contacted by phone or e-mail to participate to the CIO study. Once their agreement received, each patient will be asked to complete the same set of online questionnaires : weight, HAD (Hospital Anxiety and Depression scale), BES (Binge Eating Scale), YFAS (Yale Food Addiction Scale), DEBQ (Dutch Eating Behavior Questionnaire), IPAQ (International physical activity questionnaire), COVID 19 questionnaire Penn State, items from the Do-It questionnaire, general questions on the lifestyle during the lockdown (custom questionnaire), COVID stress evaluation (custom questionnaire)
arm group label: Obese patients with binge eating disorders
arm group label: Obese patients without binge eating disorders
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanuel DISSE, MD
role: Principal Investigator
affiliation: Centre Intégré de l'obésité de Lyon / HCL
last name: Martine LAVILLE, MD
role: Principal Investigator
affiliation: Centre Intégré de l'obésité de Lyon / HCL
facility: 
country: France
citation: Torres SJ, Nowson CA. Relationship between stress, eating behavior, and obesity. Nutrition. 2007 Nov-Dec;23(11-12):887-94. doi: 10.1016/j.nut.2007.08.008. Epub 2007 Sep 17.
PMID: 17869482
responsible party type: Sponsor
mesh term: Feeding and Eating Disorders