NCT06026059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

August 29, 2023

Last Update Submit

August 29, 2023

Conditions

Keywords

undernutritiondiagnosticscreening

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the SEFI scale as a screening tool for child's nutritional risk.

    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

Study Arms (1)

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.

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

MalnutritionDisease

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Céline BARDE

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

July 6, 2020

Primary Completion

October 6, 2022

Study Completion

October 6, 2022

Last Updated

September 6, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations