- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03327415
Nutri-Bébé 2013 Survey on Food Consumption of Infants and Young Children (NBB2013)
The French National Survey on Food Consumption of Children Under 3 Years of Age
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Montrouge, Francia, 92129
- EMERY Yves
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Age at inclusion
Lasso di tempo: January to april 2013
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months
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January to april 2013
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Weight at inclusion
Lasso di tempo: January to april 2013
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kg
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January to april 2013
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Prevalence of socio-demographic condition, feeding practice, consumption energy contribution,
Lasso di tempo: January to april 2013
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frequency in %
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January to april 2013
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Time of introducing or withdrawing a food
Lasso di tempo: history of feeding before being included in the survey
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months
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history of feeding before being included in the survey
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Mean over 3 days of Food quantities and macronutrient intake (water, protein, lipid, carbohydrate, fiber)
Lasso di tempo: January to april 2013
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g/d
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January to april 2013
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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
Lasso di tempo: January to april 2013
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mg/d
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January to april 2013
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Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten
Lasso di tempo: January to april 2013
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micro g/d
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January to april 2013
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Vitamin A intake
Lasso di tempo: January to april 2013
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RE(Retinol Equivalent)/d
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January to april 2013
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Nutrient intakes per kilogram body weight
Lasso di tempo: January to april 2013
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unit/kg/d
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January to april 2013
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Comparison with 2005 data
Lasso di tempo: 2013 vs 2005
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p value
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2013 vs 2005
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Gabriel TAVOULARIS, Engineer,MSc, CREDOC
- Investigatore principale: Yves EMERY, MSc, TNS Sofres
- Investigatore principale: Jean-Pierre CHOURAQUI, MD, MSc, CHUV Lausanne
- Direttore dello studio: Magali BOCQUET, Engineer,MSc, Secteur Français des Aliments de l'Enfance
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- Nutri-Bébé SFAE 2013
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .