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Completed

NCT Number: NCT03327415

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

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.

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Key information

Study type

Observational

Primary location

EMERY Yves

Montrouge, 92129, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Age at inclusion

    Time frame: January to april 2013

    months

  2. Weight at inclusion

    Time frame: January to april 2013

    kg

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

    Time frame: January to april 2013

    frequency in %

  4. Time of introducing or withdrawing a food

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

    months

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

    Time frame: January to april 2013

    g/d

  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

    Time frame: January to april 2013

    mg/d

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

    Time frame: January to april 2013

    micro g/d

  8. Vitamin A intake

    Time frame: January to april 2013

    RE(Retinol Equivalent)/d

Secondary outcomes

  1. Nutrient intakes per kilogram body weight

    Time frame: January to april 2013

    unit/kg/d

  2. Comparison with 2005 data

    Time frame: 2013 vs 2005

    p value

Sponsors and collaborators

Lead sponsor

Secteur Français des Aliments de l'Enfance

Industry

Collaborators

  • Centre de Recherche pour l'Etude et l'Observation des Conditions de Vie
  • TNS Sofres polling institute

Registry information

Official study title

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

Acronym: NBB2013

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Oct 31, 2017
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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