The NutriNet-Santé study is an observational prospective cohort study (open cohort) which is being conducted for a scheduled follow-up of 10 years, on a large sample of population, to study the relation between nutriton and health.
The study was launched in France on May 11, 2009, and in Belgium (Wallonia-Brussels Federation) on June 7, 2013.
The main objectives are:
1. Study the relationship between food intake, nutrients and dietary behaviour on the one hand and global and specific mortality, incidence of cancers, cancer and cardiovascular disease (CVD), obesity and overweight, type II diabetes, hypertension, dyslipidemia, metabolic syndromes, and ageing and quality of life on the other hand.
- Study the role of various determinants (sociological, economic, cultural, cognitive, perception, food preference, biological and genetic), the dietary patterns, the nutritional status and the health status
- Study the relationship between food intake, nutrients and dietary patterns and biological and clinical markers
- Survey the evolution of food intake and the nutritional status of the population over time
- Measure the level of exposure to alimentary risks
- Evaluate the impact of public health campaigns or activities (perception, efficacy, knowledge)
The huge amount of the collected information and the big sample size will enable the “NutriNet Santé” study to build a gigantic database covering the nutrition and health of the French population; it will serve as one of the biggest epidemiological data bases worldwide.
Materials and methods
It is an observational prospective cohort study conducted on a large sample size (> 500 000 registered subjects with the objective to include 300 000 participants) followed up for sufficiently long period (10 years). The participants are adults of more than 18 years; of whom at least 250 000 subjects of more than 45 years, recruited through a vast multimedia campaign (including internet) that was launched in May 2009 and relayed by many professional channels. The campaign message focus on a call for volunteering to recruit subjects “principal actors in research and public health”, contributing through their participation to the progress of the scientific knowledge. The inclusion of subjects will continue for 5 years.
All the net-users “Nutrinautes” are to be followed up via a web site especially established for the purpose (www.etude-nutrinet-sante.fr). All questionnaires and forms are ready made to be directly filled in online (net), using a secure HTML interface where all conditions of data security and confidentiality of personal information are assured.
At inclusion, all subjects are to fill-in an initial file composed of many parts: dietary questionnaires (3 records of the 24h food intake over a period of 15 days), questionnaire on physical activity, on anthropometric data, on life style and on health status. As part of their follow up programme, the Nutrinautes receive each month an automated E-mail message informing them about the study status of progress and the necessity of completing their files by filling in the new questionnaires (a link to the study web site integrated into their message).
Participation is considered firm once the participants have completely filled in the “initial set” file (basic kit). According to a pilot study, from among the 500,000 registered volunteers, we are targeting a rate of inclusion of 60 %, thereby attaining 300,000 persons having complete baseline data.
Data on the health status of the participants are be regularly collected; concerning mortality in general, causes of mortality and morbidity and the quality of life. Clinical examination and biological data will be also collected from a sub-sample (starting December 2010).
By using the national administrative mortality database, no loss of follow-up can occur in terms of this outcome in the sample of persons included. For the other main outcomes, we foresee a loss rate of 20 % among included participants due to loss-to-follow-up and dropouts, leading to a final total of 240,000 participants with complete follow-up.
It will be possible to add to the basic protocol, specific questionnaires to suit the needs of each participating research team; “à la carte” form, and to develop ancillary protocols for the sub-samples that are chosen according to particular phenotypes.
The website of the study supply general and specific information on nutrition, health and the research work. The site also maintains the link with the participant to enhance their feeling of belonging to the cohort.
The project relies mainly on the engagement of the concerned institutional partners: ministries, organisation of research, agencies and foundations. The data bank and the direct contact with the population will form a real national scientific heritage, so useful to the scientific community for research, observation, surveillance, evaluation and of a great help to the expertise.
To have access to the website of participants