Nutri-Bébé 2013 Survey on Food Consumption of Infants and Young Children

Infants Clinical Trial

— NBB2013  

Official title:

The French National Survey on Food Consumption of Children Under 3 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327415
• Other study ID #: Nutri-Bébé SFAE 2013
• Status: Completed
• Phase: N/A
• First received: October 19, 2017
• Last updated: October 26, 2017
• Start date: January 3, 2013
• Est. completion date: February 15, 2015

Study information

• Verified date: October 2017
• Source: Secteur Français des Aliments de l'Enfance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Nutri-Bébé 2013 survey is an observational cross-sectional study aiming to update food consumption, practices and nutrient intakes in children under 3 years of age in metropolitan France.

Description:

Nutri-Bébé 2013 is the 5th edition of a survey conducted every 8 years since 1981 by the SFAE. The Nutri-Bébé 2013 survey is an observational cross-sectional study conducted in children living in France aged 15 days to 35 months by an official polling institute, the TNS Sofres according to the guidelines laid down in the Declaration of Helsinki. TNS Sofres fulfills the following standards and industry requirements (ESOMAR professional code of conduct and standards, ISO 20252:2012 international standard for market, opinion and social research, French data protection act (loi "informatique et libertés "). TNS Sofres ensures to conduct the surveys in accordance with the regulation on personal data protection and that respondents' personal identity is withheld. Moreover TNS Sofres appointed a data protection officer, the "Correspondant Informatique et Libertés", who is the point of contact between the "Commission Nationale de l'Informatique et des Libertés" (CNIL), the French data protection authority) and the company. The company is thus exempted, of the notification process to the CNIL. Given the type of survey conducted, namely a survey of consumption, and the characteristics developed above, the study does not require any opinion of the ethics committee.

The survey includes a section on eating behaviours and a section on food consumption.

After giving their informed consent, parents had to record the food consumption during 3 non-consecutive days (2 week days and one weekend day)framed by two face-to-face interviews,. A second visit occurred seven days later to verify and complete the diary if necessary, and conduct a face-to-face interview with the mother about eating habits over the survey period. Both interviews were recorded using CAPI® software (Computer Assisted Personal Interviews, http://www.soft-concept.com). During this visit, the child was weighed (naked, with a clean diaper or underwear) using a Tefal PREMISS PP1000VO scale with a precision of 100 g.

The child's food consumption diary was completed between the two visits of the TNS Sofres investigator. The person in charge of the child was trained to qualitatively and quantitatively report all liquid and solid foods consumed and all drinks, by specifying the exact name of the product, its potential trademark or whether it was "homemade". The type of water consumed was noted as being either "bottled" or "tap". The type (breakfast, morning snack, lunch, afternoon snack, dinner, nocturnal food intake) and timing of food consumption were collected. If applicable, vitamin, mineral or medicine supplements were noted. During the second visit the investigator reviewed thoroughly the record with the caregiver and checked the way of reporting the quantities as well as the interpretation of the photographic tool kit in order to be as close as possible to reality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1192
• Est. completion date: February 15, 2015
• Est. primary completion date: April 21, 2013
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• informed parental consent to participate in the study,

• absence of intercurrent or chronic disease

• birth weight above 2.5 kg

Exclusion Criteria:

• Non compliance withe the study protocol

• For outcome 3 analysis (intakes), reported weight inconsistent with the child's age (> or <3 SD)

Related Conditions & MeSH terms

• Food Consumption
• Infants
• Toddlers

Locations

Country	Name	City	State
France	EMERY Yves	Montrouge

Sponsors (3)

Lead Sponsor	Collaborator
Secteur Français des Aliments de l'Enfance	Centre de Recherche pour l’Etude et l’Observation des Conditions de Vie, TNS Sofres polling institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age at inclusion	months	January to april 2013
Primary	Weight at inclusion	kg	January to april 2013
Primary	Prevalence of socio-demographic condition, feeding practice, consumption energy contribution,	frequency in %	January to april 2013
Primary	Time of introducing or withdrawing a food	months	history of feeding before being included in the survey
Primary	Mean over 3 days of Food quantities and macronutrient intake (water, protein, lipid, carbohydrate, fiber)	g/d	January to april 2013
Primary	Mean over 3 days of Intakes of Linoleic-, alpha linolenic-acids, DHA, ARA, minerals (sodiu, calcium, phosphorus, magnesium, iron, zinc), Vitamin B1,B2, B3, B6, C, E	mg/d	January to april 2013
Primary	Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten	micro g/d	January to april 2013
Primary	Vitamin A intake	RE(Retinol Equivalent)/d	January to april 2013
Secondary	Nutrient intakes per kilogram body weight	unit/kg/d	January to april 2013
Secondary	Comparison with 2005 data	p value	2013 vs 2005