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

October 4, 2023 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • CHU Montpellier - Hôpital Lapeyronie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All children admitted for hospitalization or consultation during the study period until the required number of subjects was obtained.

300 subjects 150/150 : hospitalisation/consultation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
At the inclusion
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.
Time Frame: 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.
At the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of percentage of ingesta against recommended ingesta
Time Frame: 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.
At the inclusion
Measure of undernutrition in children with the SEFI <7/10
Time Frame: 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.
At 4 months (end of the recruitment period)
Measure of nutritional deficiencies in the diet
Time Frame: 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
At the inclusion
Concordance of the SEFI administered to children and the SEFI administered to parents
Time Frame: 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.
At the inclusion
Number of children's responses to the SEFI according to age
Time Frame: At the inclusion
At the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL22_0308
  • 2022-A01448-35 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child Malnutrition

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe