Use of a 10 Points Visual Analogue Food Intake Scale for Children to Assess Intake: Prospective Study

Child Malnutrition Clinical Trial

— CESAR  

Official title:

Use of a 10 Points Visual Analogue Food Intake Scale for Children to Assess Intake: Prospective Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05726422
• Other study ID #: RECHMPL22_0308
• Secondary ID: 2022-A01448-35
• Status: Terminated
• Start date: February 27, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Data collection at the foot of the bed during hospitalization or after the consultation on a data collection form.

Conventional admission of patients to the departments involved. Carrying out the study (questionnaire and measurements) in the room. It will not be necessary to move the patients. The weighing and measuring of patients is not different from the usual care carried out during an admission to hospital in the services concerned by the study. All anthropometric measurements correspond to the recommendations of good practice. Anthropometric measurements will be performed by the health care team.

The dietary survey will be carried out by a dietician from the UTN or the pediatric team with an evaluation of the caloric intake at the time. The results will then be entered into the GENI software using the CIQUAL table in order to calculate the caloric intake (and the composition of trace elements and vitamins) according to standardized tables of food composition. The child will be accompanied by his or her parents for this survey.

The child will be asked the following question: "On a scale of 0 to 10, if 0 is "in terms of quantity, I don't eat anything at all" and 10 is "I eat as usual", between 0 and 10 where do you stand today? The same question will be asked of the parent. The parent will be blind to the child's response.

Blinding between the different assessments will be maintained as follows: the dietary survey will be conducted by a dietician blind to the SEFI scores, and the SEFI will be administered to the child and parents separately, by 2 different blind operators (childcare workers or assistant childcare workers), themselves blind to the dietary survey.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition

Locations

Country	Name	City	State
France	CHU Montpellier - Hôpital Lapeyronie	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (5)

De 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. — View Citation

Diagnostic 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

Guerdoux-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. — View Citation

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. — View Citation

Thibault 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Measure of percentage of ingesta against recommended ingesta	Concordance between a Probationary Test and a Reference Test: Probationary test; Verbal assessment of ingesta by the SEFI, administered orally to the patient.; Reference test: the percentage of caloric consumption in relation to the recommended ingesta according to age.	At the inclusion
Secondary	Measure of undernutrition in children with the SEFI <7/10	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: Diagnosis of undernutrition according to the HAS 2019.	At 4 months (end of the recruitment period)
Secondary	Measure of nutritional deficiencies in the diet	Concordance between a Probationary Test and a Reference Test: Probationary test; Verbal assessment of ingesta by the SEFI, administered orally to the patient.; Reference test: Nutrition deficeinies in the diet according to international recommendations for children's intakes	At the inclusion
Secondary	Concordance of the SEFI administered to children and the SEFI administered to parents	Concordance between a Probationary Test and a Reference Test: Probationary test; Verbal assessment of ingesta by the SEFI, administered orally to the patient.; Reference test: Verbal assessment of ingesta by the SEFI, administered orally to the parents.	At the inclusion
Secondary	Number of children's responses to the SEFI according to age		At the inclusion