<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/NCT03772301</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-0083-18</org_study_id>
    <nct_id>NCT03772301</nct_id>
  </id_info>
  <brief_title>Evaluation of Hoarding Behaviour and Eating Disorders Among Holocaust Survivors and Their Descendants</brief_title>
  <official_title>Evaluation of Hoarding Behaviour and Eating Disorders Among Holocaust Survivors and Their Descendants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</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>
      &quot;Hoarding &quot;is a common behavior among Holocaust survivors and is related to the traumatic&#xD;
      events they have experienced, and we assume that storage behavior and eating disorders are&#xD;
      related to future generations of Holocaust survivors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hoarding</measure>
    <time_frame>Three years</time_frame>
    <description>Questionnaire that will follow behaviour over generations</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Hoarding Disorder</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>At least 200 Jewish Holocaust survivors of the first generation living in Germany and Israel - an equal number in each country</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>The second generation, whose parents lived in Europe during the Second World War, now live in Germany (originating from Western and Eastern Europe) - at least 200 participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Third generation of Jewish Holocaust survivors who participated in the first phase, currently living in Germany and Israel - at least 200 participants including at least 100 subjects in each country. These are adults only. The research program does not include children and adolescents</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Jewish Holocaust survivors living in Germany and Israel Their direct offspring and their&#xD;
        children (second and third generation)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Jewish Holocaust survivors living in Germany and Israel who have expressed their&#xD;
             written and written consent to participate in monitoring and testing, and who are able&#xD;
             to answer the research questionnaires.&#xD;
&#xD;
             • Their direct offspring and their children (second and third generation)&#xD;
&#xD;
          2. The control population - non-Jewish subjects who are not the descendants of Holocaust&#xD;
             survivors living in Germany who have expressed their written and oral consent to&#xD;
             participate in monitoring and testing and who are able to answer the research&#xD;
             questionnaires and whose parents were not imprisoned in the camps second.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (Participants who do not agree to participate (did not sign informed consent form&#xD;
&#xD;
          -  Respondents who are unable to answer interviewer questions&#xD;
&#xD;
          -  Non-Jewish subjects whose parents were in camps (ie prisoner camps, labor camps, etc.)&#xD;
             during the second war.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</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>
    <mesh_term>Hoarding 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/NCT03772301
org study id: HYMC-0083-18
nct id: NCT03772301
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
"Hoarding "is a common behavior among Holocaust survivors and is related to the traumatic
      events they have experienced, and we assume that storage behavior and eating disorders are
      related to future generations of Holocaust survivors.
observational model: Ecologic or Community
time perspective: Prospective
measure: Hoarding
time frame: Three years
description: Questionnaire that will follow behaviour over generations
arm group label: Group 1
description: At least 200 Jewish Holocaust survivors of the first generation living in Germany and Israel - an equal number in each country
arm group label: Group 2
description: The second generation, whose parents lived in Europe during the Second World War, now live in Germany (originating from Western and Eastern Europe) - at least 200 participants.
arm group label: Group 3
description: Third generation of Jewish Holocaust survivors who participated in the first phase, currently living in Germany and Israel - at least 200 participants including at least 100 subjects in each country. These are adults only. The research program does not include children and adolescents
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Feeding and Eating Disorders
mesh term: Hoarding Disorder