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临床试验/NCT03335644
NCT03335644招募中不适用

The NutriNet-Santé Study. A Web-based Prospective Cohort Study of the Relationship Between Nutrition and Health and of Dietary Patterns and Nutritional Status Predictors

University of Paris 131 个研究点 分布在 1 个国家目标入组 170,000 人开始时间: 2009年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
170,000
试验地点
1
主要终点
rheumatoid arthritis using health questionnaire and/or the website for declaration of major health events

研究概览

简要总结

The NutriNet-Santé study was set up to investigate nutrition and health relationships. Specifically, it was the first web-based cohort worldwide on such a large scale (n=171 000 as of 2021) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

https://etude-nutrinet-sante.fr/ https://info.etude-nutrinet-sante.fr/en

详细描述

NutriNet-Santé is a large-scale (n=171,000) web-based cohort coordinated by EREN, launched in France in 2009 to investigate nutrition and health relationships. All required ethics authorisations have been obtained (listed here). NutriNet-Santé participants regularly fill questionnaires through a dedicated and secure website, providing extensive, high-quality nutritional and non-nutritional data, including repeated data on socio-demographics and lifestyle (yearly), anthropometrics (every 6 months), dietary intake (every 6 months), physical activity (IPAQ questionnaire, yearly)5 and health status (every 6 months). NutriNet-Santé is characterised by a very detailed and up-to-date assessment of nutritional exposure and dietary behaviours. Usual dietary intakes are assessed at baseline and every 6 months thereafter through a series of 3 non-consecutive randomly assigned 24h dietary records. Daily energy, alcohol, micro- and macronutrient intakes are calculated using the published NutriNet-Santé food composition database (>3,500 generic items). All major health events (e.g., cancers, cardio- and cerebrovascular diseases) are reported by the participants and validated by an expert committee of physicians based on medical records, and/or retrieved from the French National Health Insurance medico-administrative databases to limit potential reporting bias. In turn, mortality data are obtained from the exhaustive French National Mortality Registry (CépiDC). The number of incident events already registered is as follows: 4,200 cancers and 1,240 deaths. A sub-sample of the cohort (n=20,000) provided blood and urine samples, currently stored at -80°C in EREN's biobank.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged over 15 years
  • access to internet

排除标准

  • aged under 15 years

结局指标

主要结局

rheumatoid arthritis using health questionnaire and/or the website for declaration of major health events

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

Weight using anthropometric questionnaire

时间窗: every year after registration, up to 10 years of follow-up

self reported

Height using anthropometric questionnaire

时间窗: every year after registration, up to 10 years of follow-up

self reported

CVD using health questionnaire and/or the dedicated website for declaration of major health events

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

type 2 diabetes using health questionnaire and/or the website for declaration of major health events

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

migraine using health questionnaire and/or the website for declaration of major health events

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

cancers using health questionnaire and/or the website for declaration of major health events

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

depression using health questionnaire and/or the website for declaration of major health events

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

quality of life using the SF-36 questionnaire

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

Mortality

时间窗: continuously updated

CepiDC exhaustive national registry

SARSCOV-2 (Covid 19) infection

时间窗: regular update for a subsampe of the cohort from 2020

serology + questionnaires on symptoms

hypertension using health questionnaire and/or the website for declaration of major health events

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

metabolic syndrome using health questionnaire and/or the website for declaration of major health events

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

cognitive decline using health questionnaire and/or the website for declaration of major health events

时间窗: every 6 months after registration, up to 10 years of follow-up

self reported

multi-morbidity (mental and physical health)

时间窗: continuous update

combination of previsously listed mental and physical health outcomes

Mental health (incl. anxious disorders, sleep disorders, addictive behaviors, eating disorders)

时间窗: repeatedly during followup

self reported though validated scales and/or questionnaires

次要结局

未报告次要终点

研究者

发起方
University of Paris 13
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mathilde Touvier

Dr

University of Paris 13

研究点 (1)

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