xml: <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/NCT06026059</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/20/0059</org_study_id>
      <nct_id>NCT06026059</nct_id>
    </id_info>
    <brief_title>Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics</brief_title>
    <acronym>EFImôme</acronym>
    <official_title>Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</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>
        In current practice, there are various nutritional risk scores and diagnostic tools which are&#xD;
        used in both inpatient and outpatient settings,however, in some cases, these tools cannot be&#xD;
        used due to lack of data.&#xD;
  &#xD;
        That's why a tool that doesn't require any anthropometric parameters, such as a visual food&#xD;
        intake scale, could be useful to for medical and paramedical staff. In this way, a larger&#xD;
        proportion of the paediatric population could benefit from nutritional screening.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        HAS defines undernutrition as a state of nutritional imbalance, characterized by a negative&#xD;
        energy and/or protein balance. This negative balance may be linked to a deficit in isolated&#xD;
        intake and/or an increase in energy and/or protein expenditure.&#xD;
  &#xD;
        In current practice, there are various nutritional risk scores and diagnostic tools which are&#xD;
        used in both inpatient and outpatient settings. Practitioners can use discs to quickly and&#xD;
        easily determine BMI, which corresponds to the ratio of Weight (Kg) / Height² (m). However,&#xD;
        in some cases, these tools cannot be used due to lack of data.&#xD;
  &#xD;
        That's why a tool that doesn't require any anthropometric parameters could be useful to for&#xD;
        medical and paramedical staff. In this way, a larger proportion of the paediatric population&#xD;
        could benefit from nutritional screening.&#xD;
  &#xD;
        In adults, a visual food intake scale exists and has been validated for screening for&#xD;
        nutritional risk. The hypothesis of this study is that the visual food intake scale could be&#xD;
        a good tool for screening for nutritional risk in paediatrics&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 6, 2020</start_date>
    <completion_date type="Actual">October 6, 2022</completion_date>
    <primary_completion_date type="Actual">October 6, 2022</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of the SEFI scale as a screening tool for child's nutritional risk.</measure>
      <time_frame>Day 1</time_frame>
      <description>The correlation between the self evaluation of food intake (SEFI) scale, with scores from 0 to 10, indicating the presence of malnutrition score if score is inferior to 7 or absence of malnutrition if score superior to 7/10, and the STRONGkids score will be evaluated</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Undernutrition</condition>
    <arm_group>
      <arm_group_label>interview with the dietician</arm_group_label>
      <description>Initially, parent(s) and child will be interviewed together, details of the dietary record, as well as the data needed to calculate the nutritional risk score will be obtained.&#xD;
  The interview will then be only with the child, he will be asked to determine, on his/her own, the portion of food he/she thinks he/she ate the previous evening, using the SEFI score.&#xD;
  Finally, one of the two parents will determine, on their own, the portion of food they think their child ate the previous evening, using the SEFI score.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with a scheduled hospitalization, according to the day hospital scheduling list,&#xD;
          will be proposed to participate in the study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Child able to be weighed and measured&#xD;
  &#xD;
            -  Family with Internet access and telephone number&#xD;
  &#xD;
            -  Child and at least one parent present during day hospitalization,&#xD;
  &#xD;
            -  Child able to respond to the SEFI® scale and having completed the 3-day food intake at&#xD;
               home&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children and/or parents with comprehension and/or communication difficulties&#xD;
  &#xD;
            -  Children with any pathological condition making interpretation of results difficult&#xD;
               from the investigator's point of view&#xD;
  &#xD;
            -  Children receiving nutritional support: enteral and parenteral nutrition.&#xD;
  &#xD;
            -  Child with nutritional follow-up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Céline BARDE</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CHU Toulouse</name>
        <address>
          <city>Toulouse</city>
          <zip>31059</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>undernutrition</keyword>
    <keyword>diagnostic</keyword>
    <keyword>screening</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Malnutrition</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026059
  org study id: RC31/20/0059
  nct id: NCT06026059
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In current practice, there are various nutritional risk scores and diagnostic tools which are
        used in both inpatient and outpatient settings,however, in some cases, these tools cannot be
        used due to lack of data.
  
        That's why a tool that doesn't require any anthropometric parameters, such as a visual food
        intake scale, could be useful to for medical and paramedical staff. In this way, a larger
        proportion of the paediatric population could benefit from nutritional screening.
  HAS defines undernutrition as a state of nutritional imbalance, characterized by a negative
        energy and/or protein balance. This negative balance may be linked to a deficit in isolated
        intake and/or an increase in energy and/or protein expenditure.
  
        In current practice, there are various nutritional risk scores and diagnostic tools which are
        used in both inpatient and outpatient settings. Practitioners can use discs to quickly and
        easily determine BMI, which corresponds to the ratio of Weight (Kg) / Height² (m). However,
        in some cases, these tools cannot be used due to lack of data.
  
        That's why a tool that doesn't require any anthropometric parameters could be useful to for
        medical and paramedical staff. In this way, a larger proportion of the paediatric population
        could benefit from nutritional screening.
  
        In adults, a visual food intake scale exists and has been validated for screening for
        nutritional risk. The hypothesis of this study is that the visual food intake scale could be
        a good tool for screening for nutritional risk in paediatrics
  observational model: Cohort
  time perspective: Prospective
  measure: Evaluation of the SEFI scale as a screening tool for child's nutritional risk.
  time frame: Day 1
  description: The correlation between the self evaluation of food intake (SEFI) scale, with scores from 0 to 10, indicating the presence of malnutrition score if score is inferior to 7 or absence of malnutrition if score superior to 7/10, and the STRONGkids score will be evaluated
  arm group label: interview with the dietician
  description: Initially, parent(s) and child will be interviewed together, details of the dietary record, as well as the data needed to calculate the nutritional risk score will be obtained.
  The interview will then be only with the child, he will be asked to determine, on his/her own, the portion of food he/she thinks he/she ate the previous evening, using the SEFI score.
  Finally, one of the two parents will determine, on their own, the portion of food they think their child ate the previous evening, using the SEFI score.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 15 Years
  healthy volunteers: No
  last name: Céline BARDE
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Malnutrition
  sharing ipd: No