- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Montrouge, Francja, 92129
- EMERY Yves
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Age at inclusion
Ramy czasowe: January to april 2013
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months
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January to april 2013
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Weight at inclusion
Ramy czasowe: 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,
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: January to april 2013
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RE(Retinol Equivalent)/d
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January to april 2013
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Nutrient intakes per kilogram body weight
Ramy czasowe: 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
Ramy czasowe: 2013 vs 2005
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p value
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2013 vs 2005
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Gabriel TAVOULARIS, Engineer,MSc, CREDOC
- Główny śledczy: Yves EMERY, MSc, TNS Sofres
- Główny śledczy: Jean-Pierre CHOURAQUI, MD, MSc, CHUV Lausanne
- Dyrektor Studium: Magali BOCQUET, Engineer,MSc, Secteur Français des Aliments de l'Enfance
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Nutri-Bébé SFAE 2013
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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