- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Montrouge, Francie, 92129
- EMERY Yves
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Age at inclusion
Časové okno: January to april 2013
|
months
|
January to april 2013
|
|
Weight at inclusion
Časové okno: January to april 2013
|
kg
|
January to april 2013
|
|
Prevalence of socio-demographic condition, feeding practice, consumption energy contribution,
Časové okno: January to april 2013
|
frequency in %
|
January to april 2013
|
|
Time of introducing or withdrawing a food
Časové okno: 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)
Časové okno: 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
Časové okno: January to april 2013
|
mg/d
|
January to april 2013
|
|
Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten
Časové okno: January to april 2013
|
micro g/d
|
January to april 2013
|
|
Vitamin A intake
Časové okno: January to april 2013
|
RE(Retinol Equivalent)/d
|
January to april 2013
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Nutrient intakes per kilogram body weight
Časové okno: January to april 2013
|
unit/kg/d
|
January to april 2013
|
|
Comparison with 2005 data
Časové okno: 2013 vs 2005
|
p value
|
2013 vs 2005
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Gabriel TAVOULARIS, Engineer,MSc, CREDOC
- Vrchní vyšetřovatel: Yves EMERY, MSc, TNS Sofres
- Vrchní vyšetřovatel: Jean-Pierre CHOURAQUI, MD, MSc, CHUV Lausanne
- Ředitel studie: Magali BOCQUET, Engineer,MSc, Secteur Français des Aliments de l'Enfance
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Nutri-Bébé SFAE 2013
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .