EFImôme: Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT06026059
Collaborator
(none)
100
1
27
3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics
    Actual Study Start Date :
    Jul 6, 2020
    Actual Primary Completion Date :
    Oct 6, 2022
    Actual Study Completion Date :
    Oct 6, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    interview with the dietician

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of the SEFI scale as a screening tool for child's nutritional risk. [Day 1]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Child able to be weighed and measured

    • Family with Internet access and telephone number

    • Child and at least one parent present during day hospitalization,

    • Child able to respond to the SEFI® scale and having completed the 3-day food intake at home

    Exclusion Criteria:
    • Children and/or parents with comprehension and/or communication difficulties

    • Children with any pathological condition making interpretation of results difficult from the investigator's point of view

    • Children receiving nutritional support: enteral and parenteral nutrition.

    • Child with nutritional follow-up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Toulouse Toulouse France 31059

    Sponsors and Collaborators

    • University Hospital, Toulouse

    Investigators

    • Principal Investigator: Céline BARDE, University Hospital, Toulouse

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Toulouse
    ClinicalTrials.gov Identifier:
    NCT06026059
    Other Study ID Numbers:
    • RC31/20/0059
    First Posted:
    Sep 6, 2023
    Last Update Posted:
    Sep 6, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Toulouse
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 6, 2023