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- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Montrouge, França, 92129
- EMERY Yves
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Age at inclusion
Prazo: January to april 2013
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months
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January to april 2013
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Weight at inclusion
Prazo: 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,
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: January to april 2013
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RE(Retinol Equivalent)/d
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January to april 2013
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Nutrient intakes per kilogram body weight
Prazo: 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
Prazo: 2013 vs 2005
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p value
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2013 vs 2005
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gabriel TAVOULARIS, Engineer,MSc, CREDOC
- Investigador principal: Yves EMERY, MSc, TNS Sofres
- Investigador principal: Jean-Pierre CHOURAQUI, MD, MSc, CHUV Lausanne
- Diretor de estudo: Magali BOCQUET, Engineer,MSc, Secteur Français des Aliments de l'Enfance
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Nutri-Bébé SFAE 2013
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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