The "Self Evaluation of Food Intake" (SEFI) as a Screening Test for Hospital Malnutrition in Children Over 10 Years (SEFI)

May 2, 2023 updated by: Rennes University Hospital
The goal is to find a simple tool that can be used by medical and paramedical staff and that is reliable to identify children at risk for malnutrition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Ingesta Easy Assessment Score (SEFI®) (formerly "food intake assessment tool or EPA®") is validated in hospitals in adults to detect the risk of malnutrition and guide nutritional management. SEFI® combines a visual analogue scale (VAS) with a visual assessment of the portions consumed (www.sefi-nutrition.com). It comes in the form of a ruler equipped with a cursor and allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions. consumed (see appendix). A score <7/10 is associated with malnutrition or the risk of malnutrition.

The investigators hypothesize that, in pediatric services for children 10 years of age or older, SEFI® would be a feasible and reliable tool for screening for the risk of malnutrition.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
680

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
      • Angers, France, 49000
        • Recruiting
        • CHU Angers
        • Contact:
          • Emilie CHAILLOU, Dr
      • Paris, France, 75012
        • Recruiting
        • APHP Trousseau Paris University Hospital
        • Contact:
      • Rennes, France, 35000
        • Recruiting
        • Rennes University Hospital
        • Contact:
        • Principal Investigator:
          • Swellen Gastineau
      • Toulouse, France, 31059
        • Recruiting
        • CHU Toulouse
        • Contact:
          • Emmanuel MAS, Dr
      • Tours, France, 37044

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged 10 to 17 and hospitalized in pediatric or pediatric surgery, regardless of the reason for hospitalization

Description

Inclusion Criteria:

  • Children aged 10 to 17 and hospitalized in pediatric or pediatric surgery, regardless of the reason for hospitalization.
  • Whose holders of parental authority have received information on the protocol and have not expressed their opposition to the child's participation in the study,
  • Having received information on the protocol and not having expressed opposition to participating in the study.

Exclusion Criteria:

  • Patients whose level of understanding does not allow the use of SEFI®

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess the reliability of SEFI® for detecting the risk of acute malnutrition in pediatrics
Time Frame: 6 month
rate of agreement between the diagnoses of malnutrition obtained by the SEFI® tool and those obtained by diagnostic tools already validated in children: the Weight to Height ratio (or Waterlow index)
6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
reliability of SEFI ® to detect the risk of chronic undernutrition in pediatrics
Time Frame: 6 months
rate of agreement between the diagnoses of malnutrition obtained by the SEFI® tool and those obtained by diagnostic tools already validated in children: Weight to Age ratio and Height to Age ratio
6 months
feasibility of SEFI®
Time Frame: 6 months
Percentage of completion of the test compared to the number of subjects included in the study (if the test is carried out for each person included = 100% feasibility)
6 months
correlations of VAS results (score or portions consumed) with occurrence of complications and length of hospital stay
Time Frame: 9 months
Duration of hospitalization and complications during hospitalization
9 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gauthier Foulon, Doctor, Rennes University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 18, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35RC20_3019_SEFI
  • 2020-A00739-30 (Other Identifier: French national agency for drugs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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