NBB2013: Nutri-Bébé 2013 Survey on Food Consumption of Infants and Young Children

Sponsor
Secteur Français des Aliments de l'Enfance (Industry)
Overall Status
Completed
CT.gov ID
NCT03327415
Collaborator
TNS Sofres polling institute (Other), Centre de Recherche pour l'Etude et l'Observation des Conditions de Vie (Other)
1,192
1
25.4
46.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1192 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    The French National Survey on Food Consumption of Children Under 3 Years of Age
    Actual Study Start Date :
    Jan 3, 2013
    Actual Primary Completion Date :
    Apr 21, 2013
    Actual Study Completion Date :
    Feb 15, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Age at inclusion [January to april 2013]

      months

    2. Weight at inclusion [January to april 2013]

      kg

    3. Prevalence of socio-demographic condition, feeding practice, consumption energy contribution, [January to april 2013]

      frequency in %

    4. Time of introducing or withdrawing a food [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) [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 [January to april 2013]

      mg/d

    7. Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten [January to april 2013]

      micro g/d

    8. Vitamin A intake [January to april 2013]

      RE(Retinol Equivalent)/d

    Secondary Outcome Measures

    1. Nutrient intakes per kilogram body weight [January to april 2013]

      unit/kg/d

    2. Comparison with 2005 data [2013 vs 2005]

      p value

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 EMERY Yves Montrouge France 92129

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Gabriel TAVOULARIS, Engineer,MSc, CREDOC
    • Principal Investigator: Yves EMERY, MSc, TNS Sofres
    • Principal Investigator: Jean-Pierre CHOURAQUI, MD, MSc, CHUV Lausanne
    • Study Director: Magali BOCQUET, Engineer,MSc, Secteur Français des Aliments de l'Enfance

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Secteur Français des Aliments de l'Enfance
    ClinicalTrials.gov Identifier:
    NCT03327415
    Other Study ID Numbers:
    • Nutri-Bébé SFAE 2013
    First Posted:
    Oct 31, 2017
    Last Update Posted:
    Oct 31, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Secteur Français des Aliments de l'Enfance

    Study Results

    No Results Posted as of Oct 31, 2017