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CompletedNCT03327415NBB2013Updated Oct 31, 2017

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

An observational study in Food Consumption, Infants and Toddlers, sponsored by Secteur Français des Aliments de l'Enfance. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by Secteur Français des Aliments de l'Enfance · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,192
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Food Consumption
  • Infants
  • Toddlers

Keywords

  • Children
  • Food practice
  • Food consumption
  • Nutrient intake
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sampling method
Probability sample

Study population

The present survey is based on a randomly selected sample with socio-demographic characteristics similar to the general population living in mainland France (i.e. excluding Corsica, overseas departments, regions, and communities, and New Caledonia). A quota sampling method was used: sampling wastratified by residential area, size of the urban agglomeration, infant gender, mother's professional activity, occupational and socio-occupational status and adjusted for these different characteristics. This stratification was based on the population characteristics of the 2002 census of the National Institute for Statistics and Economic Research (INSEE, Institut National de la Statistique et des Etudes Economiques).

Inclusion criteria

  • informed parental consent to participate in the study,
  • absence of intercurrent or chronic disease
  • birth weight above 2.5 kg

Exclusion criteria

Exclusion Criteria:

  • Non compliance withe the study protocol
  • For outcome 3 analysis (intakes), reported weight inconsistent with the child's age (> or \<3 SD)
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,192 participants (actual)
Patient registry
No

Groups and cohorts

  • Age groups

    Eleven age groups that took into account the previous surveys and the key stages of child development were defined: 15 days to 3 months, 4, 5, 6, 7, 8-9, 10-11, 12- 17, 18-23, 24-29, and 30-35 months.

05

What researchers measure

Primary outcomes

  1. Age at inclusion

    months

    Time frame: January to april 2013

  2. Weight at inclusion

    kg

    Time frame: January to april 2013

  3. Prevalence of socio-demographic condition, feeding practice, consumption energy contribution,

    frequency in %

    Time frame: January to april 2013

  4. Time of introducing or withdrawing a food

    months

    Time frame: history of feeding before being included in the survey

  5. Mean over 3 days of Food quantities and macronutrient intake (water, protein, lipid, carbohydrate, fiber)

    g/d

    Time frame: January to april 2013

  6. 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

    Time frame: January to april 2013

  7. Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten

    micro g/d

    Time frame: January to april 2013

  8. Vitamin A intake

    RE(Retinol Equivalent)/d

    Time frame: January to april 2013

Secondary outcomes

  1. Nutrient intakes per kilogram body weight

    unit/kg/d

    Time frame: January to april 2013

  2. Comparison with 2005 data

    p value

    Time frame: 2013 vs 2005

06

Study locations

1 site
  • EMERY Yves
    Montrouge, 92129, France
07

References and documents

Publications

  • Chouraqui JP, Darmaun D, Salmon-Legagneur A, Shamir R. Protein intake pattern in non-breastfed infants and toddlers: A survey in a nationally representative sample of French children. Clin Nutr. 2022 Feb;41(2):269-278. doi: 10.1016/j.clnu.2021.12.006. Epub 2021 Dec 8. PubMed 34998033 ↗

Individual participant data

Plan to share: No — To be shared is the global report of results on each items (food practices, food consumption, nutrients intakes), according to age groups.

08

Registry details

Key details

Study ID
NCT03327415
Lead sponsor
Secteur Français des Aliments de l'Enfance
Collaborators
TNS Sofres polling institute, Centre de Recherche pour l'Etude et l'Observation des Conditions de Vie
Responsible party
Sponsor
First posted
Oct 31, 2017
Start date
Jan 3, 2013
Primary completion
Apr 21, 2013
Completion
Feb 15, 2015
Last update
Oct 31, 2017

Study contacts

Gabriel TAVOULARIS, Engineer,MSc
principal investigator · CREDOC
Yves EMERY, MSc
principal investigator · TNS Sofres
Jean-Pierre CHOURAQUI, MD, MSc
principal investigator · CHUV Lausanne
Magali BOCQUET, Engineer,MSc
study director · Secteur Français des Aliments de l'Enfance

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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