- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06026059
Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics (EFImôme)
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Toulouse, France, 31059
- CHU Toulouse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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
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Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Céline BARDE, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/20/0059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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