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

August 29, 2023 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

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

      • Toulouse, France, 31059
        • CHU Toulouse

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a scheduled hospitalization, according to the day hospital scheduling list, will be proposed to participate in the study

Description

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

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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the SEFI scale as a screening tool for child's nutritional risk.
Time Frame: 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
Day 1

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Céline BARDE, University Hospital, Toulouse

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)

July 6, 2020

Primary Completion (Actual)

October 6, 2022

Study Completion (Actual)

October 6, 2022

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Estimated)

September 6, 2023

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/20/0059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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