{"doc_desc":{"title":"Cohorte d'adultes d'\u00e2ge m\u00fbr : \u00e9tude des relations entre les comportements alimentaires globaux et\/ou certains facteurs nutritionnels sp\u00e9cifiques et la qualit\u00e9 du vieillissement","idno":"FRESH-PEF3916-fr","producers":[{"name":"Serge HERCBERG","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3916-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3916"},{"agency":"FReSH","code":"FRESH-PEF3916"}]},"title":"Cohorte d'adultes d'\u00e2ge m\u00fbr : \u00e9tude des relations entre les comportements alimentaires globaux et\/ou certains facteurs nutritionnels sp\u00e9cifiques et la qualit\u00e9 du vieillissement","alternate_title":"SU.VI.MAX 2"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Pilar;GALAN","PILabo":"Equipe de Recherche en Epid\u00e9miologie Nutritionnele (EREN), U1153 Inserm \/ U1125 Inra \/ Cnam \/ Universit\u00e9 Paris 13 (Sorbonne Paris-Cit\u00e9)","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"03244043X","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"RNSR","uri":"201420738K","role":"labo id"}],"email":"p.galan@eren.smbh.univ-paris13.fr","isContact":"Oui"},{"type":"investigator","name":"Serge;HERCBERG","PILabo":"Equipe de Recherche en Epid\u00e9miologie Nutritionnele (EREN), U1153 Inserm \/ U1125 Inra \/ Cnam \/ Universit\u00e9 Paris 13 (Sorbonne Paris-Cit\u00e9)","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"ORCID","uri":"0000-0002-3168-1350","role":"pi id"},{"title":"IdRef","uri":"02858709X","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"RNSR","uri":"201420738K","role":"labo id"}],"email":"s.hercberg@eren.smbh.univ-paris13.fr","isContact":"Oui"},{"type":"investigator","name":"Emmanuelle;KESSE","PILabo":"Equipe de Recherche en Epid\u00e9miologie Nutritionnele (EREN), U1153 Inserm \/ U1125 Inra \/ Cnam \/ Universit\u00e9 Paris 13 (Sorbonne Paris-Cit\u00e9)","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"ORCID","uri":"0000-0002-9715-3534","role":"pi id"},{"title":"IdRef","uri":"18131827X","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"RNSR","uri":"201420738K","role":"labo id"}],"email":"e.kesse@eren.smbh.univ-paris13.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"IPSEN INNOVATION","extlink":[{"title":"SIREN","uri":"408342616"}]},{"name":"MALAKOFF HUMANIS MUTUELLE (MHM)","extlink":[{"title":"SIREN","uri":"784718256"}]},{"name":"PIERRE FABRE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04hdhz511"}]}]},"distribution_statement":{"contact":[{"name":"Pilar;GALAN","email":"p.galan@eren.smbh.univ-paris13.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]},{"name":"Serge;HERCBERG","email":"s.hercberg@eren.smbh.univ-paris13.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]},{"name":"Emmanuelle;KESSE","email":"e.kesse@eren.smbh.univ-paris13.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"maladies chroniques"},{"keyword":"Pr\u00e9vention"},{"keyword":"mortalit\u00e9"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"G\u00e9riatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d37e4d8c-a978-40c7-ba4f-eee841851073"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005853"}]},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00e9tudier les relations entre les comportements alimentaires globaux (typologie alimentaire) et\/ou certains facteurs nutritionels sp\u00e9cifiques (apports et statut en anti-oxydants, en folates, en AGPI Omega3, apports \u00e9nerg\u00e9tiques et prot\u00e9iques, etc\u2026) \u00e9valu\u00e9s \u00e0 partir de donn\u00e9es collect\u00e9es en 1994-1996 sur une large population d'adultes d'\u00e2ge m\u00fbr, et : - la qualit\u00e9 globale du vieillissement de cette population \u00e9valu\u00e9e 12 et 15 ann\u00e9es plus tard (2006 et 2009) au travers d'un indicateur global construit \u00e0 partir de diff\u00e9rentes composantes d\u00e9terminant le vieillissement r\u00e9ussi (\u00e9tat cognitif, humeur, \u00e9tat nutritionnel, \u00e9tat osseux, troubles de l'\u00e9quilibre, troubles sensoriel, sant\u00e9 ressentie, int\u00e9gration, sociale, activit\u00e9 physique, existences de pathologies) - chacune des diff\u00e9rentes composantes fonctionnelles sp\u00e9cifiques li\u00e9es \u00e0 la qualit\u00e9 du vieillissement : fonctions cognitives et d\u00e9pression, risque de sarcop\u00e9nie, ou d'ost\u00e9oporose, insulino-r\u00e9sistance, qualit\u00e9 de vie, maladies chroniques (cancers, mal cv, cataracte, DMLA). Objectif secondaire : \u00e9valuer le r\u00f4le du stress oxydant, du statut inflammatoire, de l'insulino-r\u00e9sistance, et de certains facteurs g\u00e9n\u00e9tiques en tant que m\u00e9canismes potentiellement impliqu\u00e9s dans les relations entre les comportements nutritionnels, et\/ou certains facteurs nutritionnels sp\u00e9cifiques, et la qualit\u00e9 du vieillissement.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Sujets volontaires, ayant particip\u00e9 \u00e0 la cohorte SUI.VI.MAX, et \u00e2g\u00e9s de 55 \u00e0 70 ans\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Anthropom\u00e9trie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers le patient ou retour vers un tiers.Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi.Relance des sujets pour r\u00e9aliser les visites de suivi.R\u00e9alisation d\\'audit qualit\u00e9 interne tous les ans.Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Autre']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Recording\",\"vocab\":\"CESSDA\"},\"value\":\"Recording (audio, video, electrophysiological, imaging)Enregistrement (audio, vid\u00e9o, \u00e9lectrophysiologique, imagerie)\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}","{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Psychological\",\"vocab\":\"CESSDA\"},\"value\":\"Tests psychologiques\/\u00e9chelles cliniques (d\u00e9pression, cognition, qualit\u00e9 de vie...)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"7000"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques. Utilisation possible des donn\u00e9es par des industriels \u00e0 d\u00e9terminer.","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"20-06-2012","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2019","isContributorPI":"Non","contributorName":"Serge HERCBERG","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/www.hal.inserm.fr\/SUVIMAX"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Industrie","Priv\u00e9 \u00e0 but non lucratif","Industrie"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"- Auto-questionnaire d'enregistrement alimentaire (inclusion): donn\u00e9es de consommation alimentaires recueillies au moyen d'un questionnaire ad hoc de fr\u00e9quence alimentaire semi-quantitatif- Autres auto-questionnaires (inclusion): donn\u00e9es sur les conditions et habitudes de vie, prise r\u00e9guli\u00e8re de m\u00e9dicaments, de compl\u00e9ments en vitamines et min\u00e9raux, de traitements hormonaux substitutifs, les ant\u00e9c\u00e9dents m\u00e9dicaux, personnels et familiaux seront recueillis par des questionnaires ad hoc. - Auto-questionnaire de qualit\u00e9 de vie (inclusion): questionnaire particulier adapt\u00e9 aux personnes vieillissantes, l'activit\u00e9 physique, aspects budg\u00e9taires, alimentation et \u00e9volution des pr\u00e9f\u00e9rences alimentaires- Donn\u00e9es cliniques recueillies aupr\u00e8s du sujet (inclusion et tous les 6 mois au cours du suivi): Etat nutritionnel, fonctions cognitives, thymie, \u00e9tat clinique complet, fonctions visuelles et auditives, \u00e9tat locomoteur, \u00e9quilibre postural, risque fractures ost\u00e9oporotique, bilan neuro-psychologique, qualit\u00e9 de vie, mesures anthropom\u00e9triquesAutoquestionnaire : saisie manuelleEntretiens : saisie \u00e0 partir d\u2019un questionnaire papier avec double saisie Examens cliniques : saisie manuelle avec double saisie Examens biologiques : saisie manuelle avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi P\u00e9riodicit\u00e9 de l'examen : 2006-2009 Informations recueillies lors de l'examen clinique : \u00e9tat nutritionnel, fonctions cognitives, thymie, \u00e9tat clinique complet, fonctions visuelles et auditives, \u00e9tat locomoteur, \u00e9quilibre postural, risque fractures ost\u00e9oporotique, bilan neuro-psychologique, qualit\u00e9 de vie.","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : sang, urines","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}