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

26. oktober 2017 opdateret af: Secteur Français des Aliments de l'Enfance

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

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1192

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Montrouge, Frankrig, 92129
        • EMERY Yves

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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).

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Age at inclusion
Tidsramme: January to april 2013
months
January to april 2013
Weight at inclusion
Tidsramme: January to april 2013
kg
January to april 2013
Prevalence of socio-demographic condition, feeding practice, consumption energy contribution,
Tidsramme: January to april 2013
frequency in %
January to april 2013
Time of introducing or withdrawing a food
Tidsramme: history of feeding before being included in the survey
months
history of feeding before being included in the survey
Mean over 3 days of Food quantities and macronutrient intake (water, protein, lipid, carbohydrate, fiber)
Tidsramme: January to april 2013
g/d
January to april 2013
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
Tidsramme: January to april 2013
mg/d
January to april 2013
Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten
Tidsramme: January to april 2013
micro g/d
January to april 2013
Vitamin A intake
Tidsramme: January to april 2013
RE(Retinol Equivalent)/d
January to april 2013

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nutrient intakes per kilogram body weight
Tidsramme: January to april 2013
unit/kg/d
January to april 2013
Comparison with 2005 data
Tidsramme: 2013 vs 2005
p value
2013 vs 2005

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. januar 2013

Primær færdiggørelse (Faktiske)

21. april 2013

Studieafslutning (Faktiske)

15. februar 2015

Datoer for studieregistrering

Først indsendt

19. oktober 2017

Først indsendt, der opfyldte QC-kriterier

26. oktober 2017

Først opslået (Faktiske)

31. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Nutri-Bébé SFAE 2013

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

To be shared is the global report of results on each items (food practices, food consumption, nutrients intakes), according to age groups.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner