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The NutriNet-Santé Study

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ClinicalTrials.gov Identifier: NCT03335644
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Recherche Agronomique
Conservatoire national des Arts et Métiers
Information provided by (Responsible Party):
Serge HERCBERG, University of Paris 13

Study Description
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Brief Summary:
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=160 000 as of 2017) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

Condition or disease
Diet, Food, and Nutrition Exercise Diseases Category Cohort Studies Adult Anthropometry Humans Internet Surveys and Questionnaires Mortality

Detailed Description:

The objectives of the NutriNet-Santé study are: 1) to investigate the relationship between nutrition (nutrients, foods, dietary patterns, physical activity), mortality and health outcomes; and 2) to examine the determinants of dietary patterns and nutritional status (sociological, economic, cultural, biological, cognitive, perceptions, preferences, etc.), using a web-based approach.

This web-based prospective cohort study is being conducted for a scheduled follow-up of 10 years. Using a dedicated web site, recruitment is carried out for 10 years so as to register volunteers aged >/= 18 years. Questionnaires administered via internet at baseline and each year thereafter assess socio-demographic and lifestyle characteristics, anthropometry, health status, physical activity and diet. Surveillance of health events are implemented via questionnaires on hospitalisation and use of medication, and linkage with a national database on vital statistics. Biochemical samples and clinical examination have been collected in a subsample of volunteers.


Study Design
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Study Type : Observational
Estimated Enrollment : 160000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : May 11, 2009
Estimated Primary Completion Date : May 11, 2019
Estimated Study Completion Date : May 11, 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. cancers using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  2. CVD using health questionnaire and/or the dedicated website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  3. type 2 diabetes using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  4. hypertension using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  5. metabolic syndrome using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  6. depression using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  7. migraine using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  8. rheumatoid arthritis using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  9. cognitive decline using health questionnaire and/or the website for declaration of major health events [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  10. quality of life using the SF-36 questionnaire [ Time Frame: every 6 months after registration, up to 10 years of follow-up ]
    self reported

  11. Weight using anthropometric questionnaire [ Time Frame: every year after registration, up to 10 years of follow-up ]
    self reported

  12. Height using anthropometric questionnaire [ Time Frame: every year after registration, up to 10 years of follow-up ]
    self reported


Biospecimen Retention:   Samples With DNA
Samples of serum, plasma, and buffy-coats (for genetic analyses), as well as urine samples was set up for 19 600 subjects of the cohort.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The NutriNet-Santé study is a French ongoing web-based cohort launched in 2009 with the objective to study the associations between nutrition and health as well as the determinants of dietary behaviors and nutritional status. This cohort has been previously described in details (citations). Participants aged over 18 years with access to the Internet are recruited by vast multimedia campaigns. All questionnaires are completed online using a dedicated website (www.etude-nutrinet-sante.fr).
Criteria

Inclusion Criteria:

  • aged over 18 years
  • access to internet

Exclusion Criteria:

  • aged under 18 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335644


Contacts
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Contact: Serge Hercberg, Pr +33148388976 s.hercberg@eren.smbh.univ-paris13.fr

Locations
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France
EREN Recruiting
Bobigny, Seine Saint Denis, France, 93017
Contact: Serge Hercberg, Pr    +33148388976    s.hercberg@eren.smbh.univ-paris13.fr   
Sub-Investigator: Pilar Galan, Dr         
Sub-Investigator: Mathilde Touvier, Dr         
Sub-Investigator: Emmanuelle Kesse-Guyot, Dr         
Sub-Investigator: Sandrine Péneau, Dr         
Sub-Investigator: Léopold Fezeu, Dr         
Sub-Investigator: Chantal Julia, Dr         
Sub-Investigator: Valentina Andreeva, Dr         
Sponsors and Collaborators
University of Paris 13
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Recherche Agronomique
Conservatoire national des Arts et Métiers
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
PubMed abstract  This link exits the ClinicalTrials.gov site Scalable listing of all the questionnaires sent to the participants  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Serge HERCBERG, Professor, Dr, University of Paris 13
ClinicalTrials.gov Identifier: NCT03335644     History of Changes
Other Study ID Numbers: NutriNet-Santé
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Serge HERCBERG, University of Paris 13:
determinants of dietary patterns and nutritional status