CESAR: Use of a 10 Points Visual Analogue Food Intake Scale for Children to Assess Intake: Prospective Study

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05726422
Collaborator
(none)
300
3.4

Study Details

Study Description

Brief Summary

In hospitalized children, undernutrition increases the length of hospitalization, aggravates the causal pathology, favors the occurrence of complications, and increases the cost of hospitalization. With a prevalence of 10 to 20%, undernutrition is therefore a major problem which, moreover, is largely under-diagnosed.

The evaluation of food intake has historically been based on the evaluation of food consumption by means of a food card or a food survey during the last 24 hours.

In adults, a rapid assessment tool has been developed, the SEFI® (Score Evaluation Facile des Ingestats), consisting of a visual analog scale (VAS) graduated from 0 to 10. It has been validated as being concordant with previous tools for the assessment of dietary intake in the general population and is now recommended for adults. It allows early identification of a risk of undernutrition when the score is < 7/10.

We propose to evaluate the correlation between this 10-point analog scale (SEFI) and ingesta in children in relation to recommended energy intakes for age and weight.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Data collection at the foot of the bed during hospitalization or after the consultation on a data collection form.

    Conventional admission of patients to the departments involved. Carrying out the study (questionnaire and measurements) in the room. It will not be necessary to move the patients. The weighing and measuring of patients is not different from the usual care carried out during an admission to hospital in the services concerned by the study. All anthropometric measurements correspond to the recommendations of good practice. Anthropometric measurements will be performed by the health care team.

    The dietary survey will be carried out by a dietician from the UTN or the pediatric team with an evaluation of the caloric intake at the time. The results will then be entered into the GENI software using the CIQUAL table in order to calculate the caloric intake (and the composition of trace elements and vitamins) according to standardized tables of food composition. The child will be accompanied by his or her parents for this survey.

    The child will be asked the following question: "On a scale of 0 to 10, if 0 is "in terms of quantity, I don't eat anything at all" and 10 is "I eat as usual", between 0 and 10 where do you stand today? The same question will be asked of the parent. The parent will be blind to the child's response.

    Blinding between the different assessments will be maintained as follows: the dietary survey will be conducted by a dietician blind to the SEFI scores, and the SEFI will be administered to the child and parents separately, by 2 different blind operators (childcare workers or assistant childcare workers), themselves blind to the dietary survey.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Use of a 10 Points Visual Analogue Food Intake Scale for Children to Assess Intake: Prospective Study
    Anticipated Study Start Date :
    Feb 15, 2023
    Anticipated Primary Completion Date :
    May 31, 2023
    Anticipated Study Completion Date :
    May 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. To assess the diagnostic validity of the SEFI, a 10-item self-administered numerical scale assessing food intake, for the diagnosis of decreased ingesta in children. [At the inclusion]

      Concordance between a Probationary Test and a Reference Test: Probationary test Verbal assessment of ingesta by the SEFI, administered orally to the patient. the thresholds that will be tested is <7/10. Reference test Ingesta representing at least 2/3 of recommended ingesta. Ingesta is assessed by a 24-hour recall performed by a dietician with children, accompanied by their parents.

    2. To assess the diagnostic validity of the SEFI, a 10-item self-administered numerical scale assessing food intake, for the diagnosis of decreased ingesta in children. [At the inclusion]

      Concordance between a Probationary Test and a Reference Test: Probationary test Verbal assessment of ingesta by the SEFI, administered orally to the patient. the thresholds that will be tested is <10/10. Reference test Ingesta representing at least 2/3 of recommended ingesta. Ingesta is assessed by a 24-hour recall performed by a dietician with children, accompanied by their parents.

    Secondary Outcome Measures

    1. Measure of percentage of ingesta against recommended ingesta [At the inclusion]

      Concordance between a Probationary Test and a Reference Test: Probationary test Verbal assessment of ingesta by the SEFI, administered orally to the patient. Reference test: the percentage of caloric consumption in relation to the recommended ingesta according to age.

    2. Measure of undernutrition in children with the SEFI <7/10 [At 4 months (end of the recruitment period)]

      Concordance between a Probationary Test and a Reference Test: Probationary test Verbal assessment of ingesta by the SEFI, administered orally to the patient. The thresholds that will be tested is <7/10. Reference test: Diagnosis of undernutrition according to the HAS 2019.

    3. Measure of nutritional deficiencies in the diet [At the inclusion]

      Concordance between a Probationary Test and a Reference Test: Probationary test Verbal assessment of ingesta by the SEFI, administered orally to the patient. Reference test: Nutrition deficeinies in the diet according to international recommendations for children's intakes

    4. Concordance of the SEFI administered to children and the SEFI administered to parents [At the inclusion]

      Concordance between a Probationary Test and a Reference Test: Probationary test Verbal assessment of ingesta by the SEFI, administered orally to the patient. Reference test: Verbal assessment of ingesta by the SEFI, administered orally to the parents.

    5. Number of children's responses to the SEFI according to age [At the inclusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient aged 6 months to less than 18 years

    • Patient admitted in short and long stay pediatric services at the Montpellier University Hospital, other than maternity, neonatality, palliative care or intensive care, excluding SSR.

    • Patient admitted for day hospitalization or consultation at the Montpellier University Hospital

    Exclusion Criteria:
    • Opposition from parents or child

    • Pathology involving the satiety centers

    • Breast-fed child

    • Proven disorder of orality

    • Strict fasting by the medical team

    • Anorexia nervosa

    • Consciousness disorder

    • Exclusive artificial feeding

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05726422
    Other Study ID Numbers:
    • RECHMPL22_0308
    • 2022-A01448-35
    First Posted:
    Feb 14, 2023
    Last Update Posted:
    Feb 14, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 14, 2023