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临床试验/NCT03327415
NCT03327415已完成不适用

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

Secteur Français des Aliments de l'Enfance1 个研究点 分布在 1 个国家目标入组 1,192 人开始时间: 2013年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,192
试验地点
1
主要终点
Weight at inclusion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

接受健康志愿者

入选标准

  • informed parental consent to participate in the study,
  • absence of intercurrent or chronic disease
  • birth weight above 2.5 kg

排除标准

  • Non compliance withe the study protocol
  • For outcome 3 analysis (intakes), reported weight inconsistent with the child's age (> or <3 SD)

结局指标

主要结局

Weight at inclusion

时间窗: January to april 2013

kg

Time of introducing or withdrawing a food

时间窗: history of feeding before being included in the survey

months

Vitamin A intake

时间窗: January to april 2013

RE(Retinol Equivalent)/d

Prevalence of socio-demographic condition, feeding practice, consumption energy contribution,

时间窗: January to april 2013

frequency in %

Mean over 3 days of intakes of Vitamin B9, B12, Retinol, Beta-caroten

时间窗: January to april 2013

micro g/d

Age at inclusion

时间窗: January to april 2013

months

Mean over 3 days of Food quantities and macronutrient intake (water, protein, lipid, carbohydrate, fiber)

时间窗: January to april 2013

g/d

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

时间窗: January to april 2013

mg/d

次要结局

  • Comparison with 2005 data(2013 vs 2005)
  • Nutrient intakes per kilogram body weight(January to april 2013)

研究者

发起方
Secteur Français des Aliments de l'Enfance
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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