{"doc_desc":{"title":"Etude longitudinale en France de l\u2019alimentation et de l\u2019\u00e9tat nutritionnel des enfants pendant leur premi\u00e8re ann\u00e9e de vie","idno":"FRESH-PEF7768-fr","producers":[{"name":"Beno\u00eet SALANAVE","affiliation":"SANTE PUBLIQUE FRANCE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF7768-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"7768"},{"agency":"FReSH","code":"FRESH-PEF7768"}]},"title":"Etude longitudinale en France de l\u2019alimentation et de l\u2019\u00e9tat nutritionnel des enfants pendant leur premi\u00e8re ann\u00e9e de vie","alternate_title":"Epifane"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Beno\u00eet;SALANAVE","firstname":"Beno\u00eet","lastname":"SALANAVE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58","role":"organisation id"},{"title":"SIREN","uri":"130022338","role":"organisation id"}],"email":"Benoit.salanave@univ-paris13.fr","affiliationName":"SANTE PUBLIQUE FRANCE","PILabo":"Sant\u00e9 publique France \/ Equipe de surveillance et d\u2019\u00e9pid\u00e9miologie nutritionnelle (ESEN)","isContact":true}],"oth_id":[{"name":"- Universit\u00e9 Paris 13- Groupe IReSP sur les \u00ab \u00e9tudes \u00e9pid\u00e9miologiques m\u00e8re\/enfant \u00bb- Collaboration avec l\u2019\u00e9quipe Elfe pour l\u2019adoption de d\u00e9finitions et de proc\u00e9dures communes dans le traitement des donn\u00e9es relatives \u00e0 l\u2019alimentation des nourrissons","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58","role":"sponsor id"},{"title":"SIREN","uri":"130022338","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]}]},"distribution_statement":{"contact":[{"name":"Beno\u00eet;SALANAVE","lastname":"SALANAVE","firstname":"Beno\u00eet","type":"contact","email":"Benoit.salanave@univ-paris13.fr","affiliationName":"SANTE PUBLIQUE FRANCE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00dfw9p58","role":"organisation id","title":"ROR"},{"uri":"130022338","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Allaitement maternel"},{"keyword":"formules lact\u00e9es du commerce"},{"keyword":"diversification alimentaire"},{"keyword":"nourrissons"},{"keyword":"alimentation"},{"keyword":"nutrition"},{"keyword":"croissance"},{"keyword":"in\u00e9galit\u00e9s sociales de sant\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":"Gyn\u00e9cologie et obst\u00e9trique","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7de64596-5b0d-4977-8f98-b982ff2ec17d"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/284ca20c-beb4-4abe-99fa-ef4513358bad"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006176"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009774"}]},{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"D\u00e9crire, sur un \u00e9chantillon national d'enfants n\u00e9s en France m\u00e9tropolitaine, l'alimentation pendant la premi\u00e8re ann\u00e9e de vie, en estimant en particulier : (i) la fr\u00e9quence, la dur\u00e9e et l\u2019exclusivit\u00e9 de l\u2019allaitement maternel, (ii) le type, la dur\u00e9e et les quantit\u00e9s utilis\u00e9es de formules lact\u00e9es du commerce et (iii) les modalit\u00e9s de la diversification alimentaire (moment d\u2019introduction des nouveaux aliments, natures et quantit\u00e9s).","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2013-01-01"}],"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d\u2019inclusion du nouveau-n\u00e9 : \u00eatre n\u00e9 dans l\u2019une des maternit\u00e9s s\u00e9lectionn\u00e9es,  \u00e0 33 semaines d\u2019am\u00e9norrh\u00e9e ou plus, d\u2019une m\u00e8re majeure, r\u00e9sidant en France m\u00e9tropolitaine dans un foyer ordinaire, parlant, lisant, et \u00e9crivant le fran\u00e7ais, ou pouvant se faire assister dans le remplissage des autoquestionnaires ; ne pas avoir \u00e9t\u00e9 transf\u00e9r\u00e9 dans un autre service hospitalier dans les jours suivant la naissance et ne pas pr\u00e9senter une pathologie lourde ant\u00e9natale, n\u00e9cessitant une chirurgie, une prise en charge particuli\u00e8re ou un transfert. Cela comprend toute affection contre-indiquant une alimentation ent\u00e9rale pendant une dur\u00e9e de plus de trois semaines, et toute affection dont on sait qu\u2019elle va n\u00e9cessiter une hospitalisation n\u00e9onatale pendant une dur\u00e9e de plus de trois semaines. Les enfants mort-n\u00e9s, d\u00e9c\u00e9d\u00e9s ou dont la m\u00e8re est d\u00e9c\u00e9d\u00e9e en couche ne seront pas inclus dans l\u2019\u00e9tude.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es comportementales']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Internes \u00e0 l\u2019unit\u00e9']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Stratified\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : stratifi\u00e9\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"3368 couples m\u00e8re-enfant inclus \u00e0 la maternit\u00e9 dont 2806 suivis \u00e0 12 mois."},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"","conditions":"Demande aupr\u00e8s du responsable scientifique de l\u2019\u00e9tude ou sur le site internet, selon les modalit\u00e9s en cours \u00e0 Sant\u00e9 publique France","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":"17-12-2013","lastUpdatedAuto":null,"lastUpdatedManual":"16-05-2018","isContributorPI":false,"contributorName":"Beno\u00eet SALANAVE","contributorAffiliation":"SANTE PUBLIQUE FRANCE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Deux questionnaires \u00e9taient remplis \u00e0 la maternit\u00e9 : l\u2019un par la m\u00e8re, notamment sur son \u00e2ge, sa taille et son poids avant la grossesse, son statut par rapport \u00e0 l\u2019emploi, son niveau d\u2019\u00e9ducation, sa situation maritale et les modalit\u00e9s d\u2019alimentation lact\u00e9e de son enfant lors des premiers jours \u00e0 la maternit\u00e9 ; l\u2019autre par la sage-femme, sur les ant\u00e9c\u00e9dents m\u00e9dicaux et obst\u00e9tricaux, la date d\u2019accouchement, et l\u2019issue de la grossesse.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Couples m\u00e8re-enfant s\u00e9lectionn\u00e9s al\u00e9atoirement entre le 16 janvier et le 5 avril 2012 dans 136 maternit\u00e9s en France m\u00e9tropolitaine. Le suivi \u00e9tait r\u00e9alis\u00e9 par entretiens t\u00e9l\u00e9phoniques et autoquestionnaires (internet ou papier) \u00e0 1, 4, 8 et 12 mois."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}