Study Stopped
Sufficient number of subjects included for analyzes
Use of a 10 Points Visual Analogue Food Intake Scale for Children to Assess Intake: Prospective Study
CESAR
2 other identifiers
observational
102
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2023
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedOctober 6, 2023
August 1, 2023
3 months
January 19, 2023
October 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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 Outcomes (5)
Measure of percentage of ingesta against recommended ingesta
At the inclusion
Measure of undernutrition in children with the SEFI <7/10
At 4 months (end of the recruitment period)
Measure of nutritional deficiencies in the diet
At the inclusion
Concordance of the SEFI administered to children and the SEFI administered to parents
At the inclusion
Number of children's responses to the SEFI according to age
At the inclusion
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Montpellier - Hôpital Lapeyronie
Montpellier, 34090, France
Related Publications (5)
Hankard R, Colomb V, Piloquet H, Bocquet A, Bresson JL, Briend A, Chouraqui JP, Darmaun D, Dupont C, Frelut ML, Girardet JP, Goulet O, Rieu D, Simeoni U, Turck D, Vidailhet M. [Malnutrition screening in clinical practice]. Arch Pediatr. 2012 Oct;19(10):1110-7. doi: 10.1016/j.arcped.2012.07.024. Epub 2012 Sep 5. French.
PMID: 22959889BACKGROUNDDiagnostic de la dénutrition de l'enfant et de l'adulte [Internet]. Haute Autorité de Santé. [cited 2021 May 24]. Available from: https://www.has-sante.fr/jcms/p_3118872/fr/diagnostic-de-la-denutrition-de-l-enfant-et-de-l-adulte
BACKGROUNDThibault R, Goujon N, Le Gallic E, Clairand R, Sebille V, Vibert J, Schneider SM, Darmaun D. Use of 10-point analogue scales to estimate dietary intake: a prospective study in patients nutritionally at-risk. Clin Nutr. 2009 Apr;28(2):134-40. doi: 10.1016/j.clnu.2009.01.003. Epub 2009 Feb 14.
PMID: 19223093BACKGROUNDGuerdoux-Ninot E, Flori N, Janiszewski C, Vaille A, de Forges H, Raynard B, Baracos VE, Thezenas S, Senesse P. Assessing dietary intake in accordance with guidelines: Useful correlations with an ingesta-Verbal/Visual Analogue Scale in medical oncology patients. Clin Nutr. 2019 Aug;38(4):1927-1935. doi: 10.1016/j.clnu.2018.06.974. Epub 2018 Jun 30.
PMID: 30355527BACKGROUNDDe Longueville C, Robert M, Debande M, Podlubnai S, Defourny S, Namane SA, Pace A, Brans C, Cayrol E, Goyens P, De Laet C. Evaluation of nutritional care of hospitalized children in a tertiary pediatric hospital. Clin Nutr ESPEN. 2018 Jun;25:157-162. doi: 10.1016/j.clnesp.2018.02.008. Epub 2018 Mar 14.
PMID: 29779812BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2023
First Posted
February 14, 2023
Study Start
February 27, 2023
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
October 6, 2023
Record last verified: 2023-08