<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/NCT03264495</url>
  </required_header>
  <id_info>
    <org_study_id>VAN WYMELBEKE 2016</org_study_id>
    <nct_id>NCT03264495</nct_id>
  </id_info>
  <brief_title>Measuring the Quantities of Food Consumed by Patients Hospitalised in a Geriatric Centre</brief_title>
  <acronym>PESALI</acronym>
  <official_title>Recording Food Consumption in Patients Hospitalised in a Geriatric Centre</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      The objective of the study is to measure the quantities of food consumed at each meal by a&#xD;
      representative part of the population of patients hospitalised in each department of the&#xD;
      Champmaillot Geriatric Centre.&#xD;
&#xD;
      To do so, the quantity eaten will be quantified by weighing the amounts served and&#xD;
      subtracting the weight of the left-overs. These measurements will allow us to provide more&#xD;
      appropriate meals in the second step.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Weigh the food served and the left-overs</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Age ≥ 65 Years</condition>
  <condition>Hospitalisation in the Champmaillot Geriatric Centre</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Weight the food served minus the left-overs</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly persons hospitalised at the Champmaillot Geriatric Centre&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons aged ≥ 65 years&#xD;
&#xD;
          -  Persons hospitalised in the Champmaillot Geriatric Centre&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons at the end of life&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Patrick MANCKOUNDIA</last_name>
    <phone>03.80.29.39. 70</phone>
    <phone_ext>+33</phone_ext>
    <email>patrick.manckoundia@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick MANCKOUNDIA</last_name>
      <phone>03 80 29 39 70</phone>
      <phone_ext>+33</phone_ext>
      <email>patrick.manckoundia@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03264495
org study id: VAN WYMELBEKE 2016
nct id: NCT03264495
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to measure the quantities of food consumed at each meal by a
      representative part of the population of patients hospitalised in each department of the
      Champmaillot Geriatric Centre.

      To do so, the quantity eaten will be quantified by weighing the amounts served and
      subtracting the weight of the left-overs. These measurements will allow us to provide more
      appropriate meals in the second step.
observational model: Other
time perspective: Prospective
measure: Weigh the food served and the left-overs
time frame: 1 day
intervention type: Other
intervention name: Weight the food served minus the left-overs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick MANCKOUNDIA
phone: 03.80.29.39. 70
phone ext: +33
email: patrick.manckoundia@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor