{"doc_desc":{"title":"Suivi des participants de l'essai d'intervention pour la pr\u00e9vention primaire du diab\u00e8te de type 2 et du syndrome m\u00e9tabolique \u00e0 La R\u00e9union","idno":"FRESH-PEF20903-fr","producers":[{"name":"Adrian FIANU","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF20903-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"20903"},{"agency":"FReSH","code":"FRESH-PEF20903"}]},"title":"Suivi des participants de l'essai d'intervention pour la pr\u00e9vention primaire du diab\u00e8te de type 2 et du syndrome m\u00e9tabolique \u00e0 La R\u00e9union","alternate_title":"REDIA-prev1 Cohorte"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"},{"name":"ANSM"}]},"authoring_entity":[{"type":"investigator","name":"Fran\u00e7ois;FAVIER","PILabo":"CHU de La R\u00e9union \/ CENTRE D'INVESTIGATION CLINIQUE DE LA R\u00c9UNION (CIC 1410) INSERM \/ CHU","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"181394200","role":"pi id"},{"title":"SIREN","uri":"200030013","role":"organisation id"},{"title":"RNSR","uri":"200318009S","role":"labo id"}],"email":"francois.favier@chu-reunion.fr","isContact":"Oui"},{"type":"investigator","name":"Adrian;FIANU","PILabo":"CHU de La R\u00e9union \/ CENTRE D'INVESTIGATION CLINIQUE DE LA R\u00c9UNION (CIC 1410) INSERM \/ CHU","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","extlink":[{"title":"ORCID","uri":"0000-0002-1496-1801","role":"pi id"},{"title":"IdRef","uri":"22983325X","role":"pi id"},{"title":"SIREN","uri":"200030013","role":"organisation id"},{"title":"RNSR","uri":"200318009S","role":"labo id"}],"email":"adrian.fianu@chu-reunion.fr","isContact":"Oui"}],"oth_id":[{"name":"Equipe de recherche : \u00c9quipe EQUITY constitutive du CERPOP (UMR1295, unit\u00e9 mixte INSERM-Universit\u00e9 Paul Sabatier) \u00e0 Toulouse","type":"collaboration"}],"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":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/004dan487"},{"title":"SIREN","uri":"200030013"}]},{"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":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Fran\u00e7ois;FAVIER","email":"francois.favier@chu-reunion.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/004dan487","role":"organisation id","title":"ROR"},{"uri":"200030013","role":"organisation id","title":"SIREN"}]},{"name":"Adrian;FIANU","email":"adrian.fianu@chu-reunion.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/004dan487","role":"organisation id","title":"ROR"},{"uri":"200030013","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"adiposit\u00e9"},{"keyword":"statut glyc\u00e9mique"},{"keyword":"population vuln\u00e9rable"},{"keyword":"activit\u00e9 physique"},{"keyword":"alimentation"},{"keyword":"\u00e9tude quasi-exp\u00e9rimentale"},{"keyword":"approche communautaire"},{"keyword":"pr\u00e9vention primaire"},{"keyword":"suivi de cohorte post-essai"},{"keyword":"effet \u00e0 long terme"},{"keyword":"transf\u00e9rabilit\u00e9"},{"keyword":"intervention sur le mode de vie"}],"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":"Diab\u00e8te sucr\u00e9 de type 2","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/119724091","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"}],"purpose":"Objectif principal : \u00e9valuer l'effet \u00e0 long terme d'une intervention favorisant l'alimentation \u00e9quilibr\u00e9e et la pratique d'une activit\u00e9 physique mod\u00e9r\u00e9e r\u00e9guli\u00e8re, sur le poids corporel et l'adiposit\u00e9 (tour de taille, masse grasse) de jeunes adultes \u00e0 risque de diab\u00e8te de type 2 (DT2). Objectifs secondaires : - Comparer l\u2019\u00e9volution du poids corporel et de l'adiposit\u00e9 entre groupes (intervention versus t\u00e9moin), \u00e0 l\u2019\u00e9chelle de la cohorte enti\u00e8re sur l'ensemble des personnes d\u00e9pist\u00e9es (\u00e0 risque ou non). - Comparer le comportement alimentaire et l\u2019activit\u00e9 physique d\u00e9clar\u00e9s au suivi, entre groupes, puis selon la participation ant\u00e9rieure \u00e0 l\u2019intervention. - Comparer l\u2019incidence des anomalies glyc\u00e9miques d\u00e9pist\u00e9es, entre groupes et selon le niveau de risque initial. - D\u00e9crire l\u2019\u00e9volution des connaissances et repr\u00e9sentations sur le DT2 et l\u2019ob\u00e9sit\u00e9 (CACP).","abstract":"","coll_dates":[{"start":"2001-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['La R\u00e9union']","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 (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\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    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"La population \u00e9ligible cibl\u00e9e par l'essai d'intervention sur le mode de vie \u00e9tait compos\u00e9e d'hommes et de femmes (non enceintes), \u00e2g\u00e9s entre 18 et 40 ans, sans maladie grave connue (par exemple: diab\u00e8te, maladies cardiovasculaires, cancer) ni handicap (incompatible avec la pratique d'une activit\u00e9 physique), r\u00e9sidant sur les quartiers \u00e9tudi\u00e9s, et d\u00e9pist\u00e9s \u00e0 domicile comme \u00e9tant \\\"\u00e0 risque de DT2\\\".   La d\u00e9finition du statut \u00e0 risque reposait sur la pr\u00e9sence d\u2019une combinaison de facteurs de risque du DT2:  ob\u00e9sit\u00e9 g\u00e9n\u00e9rale (indice de masse corporelle sup\u00e9rieur \u00e0 30 kg\\\/m\u00b2) ou d'une ob\u00e9sit\u00e9 centrale (tour de taille sup\u00e9rieur \u00e0 100 cm chez les hommes et \u00e0 90 cm chez les femmes) ou bien sur la pr\u00e9sence d\u2019un surpoids associ\u00e9 \u00e0 au moins un autre facteur de risque du DT2 *.   *: Hypertension art\u00e9rielle trait\u00e9e ou d\u00e9pist\u00e9e (sup\u00e9rieure \u00e0 140\\\/90 mm Hg), taux d\u2019h\u00e9moglobine glyqu\u00e9e (HbA1c) \u00e0 la limite sup\u00e9rieure (5,5-5,9 %), ant\u00e9c\u00e9dent familial direct de diab\u00e8te (et pour les femmes: ant\u00e9c\u00e9dent d\u2019enfant pesant plus de 4 kg \u00e0 la naissance et\\\/ou ant\u00e9c\u00e9dent de diab\u00e8te gestationnel).  Les personnes d\u00e9pist\u00e9es sans statut \u00e0 risque \u00e9taient donc non ob\u00e8ses (et si en surpoids sans autres facteurs de risque du DT2 parmi ceux list\u00e9s ci-dessus). Ces personnes collat\u00e9rales ont \u00e9t\u00e9 int\u00e9gr\u00e9es dans le processus de suivi de cohorte avec les sujets \u00e0 risque. Mais ils ne participaient pas \u00e0 l'analyse de l\u2019\u00e9valuation de l'effet \u00e0 long terme (objectif principal de la recherche).   Tous les sujets ont \u00e9t\u00e9 d\u00e9pist\u00e9s comme non diab\u00e9tiques par une mesure d'HbA1c < 6.0 %.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"['Indice de masse corporelle (IMC) : seuils de corpulence OMS pour les adultes. Activit\u00e9 physique : items du questionnaire de Baecke et al. Am J Clin Nutr 1982. Consommation alimentaire : estimation des portionsalimentaires par l\\'album photo de l\\'\u00e9quipe INSERM E3N. PCS (professions et cat\u00e9gories socioprofessionnelles) : nomenclature INSEE.']","committee":"","governance":""}],"other_quality_statement":"['Relance des sujets pour r\u00e9aliser les visites de suivi, sujets ensuite inform\u00e9s de l\\'utilisation de leurs donn\u00e9es. - Monitoring par ARC d\u00e9l\u00e9gu\u00e9 par le promoteur : apr\u00e8s la premi\u00e8re inclusion, r\u00e9guli\u00e8rement selon la vitesse du suivi et les d\u00e9viations constat\u00e9es, en fin d\\'\u00e9tude. - Audit \/ inspection : \u00e0 tout moment en cours d\\'\u00e9tude,jusque 15 ans apr\u00e8s la cl\u00f4ture de l\\'\u00e9tude. Un audit inter CIC (INSERM Institut th\u00e9matique Sant\u00e9 Publique P\u00f4le Recherche Clinique) a \u00e9t\u00e9 effectu\u00e9 en novembre 2011. - Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence : au moment de la saisie des donn\u00e9es informatiques. - Gestion des donn\u00e9es manquantes : retour vers le sujet au plus pr\u00e8s de la visite r\u00e9alis\u00e9e. - Data management avant analyse statistique des donn\u00e9es']"}},"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\":\"Nonprobability.Purposive\",\"vocab\":\"CESSDA\"},\"value\":\"Non probabiliste : raisonn\u00e9 ou par \\\"jugement\\\"\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base de population \u00e0 finalit\u00e9 statistique']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Educational\",\"vocab\":\"CESSDA\"},\"value\":\"Tests \u00e9ducatifs \/ \u00e9valuation des connaissances en sant\u00e9 (litt\u00e9ratie, autogestion, interpr\u00e9tation d\u2019informations m\u00e9dicales...)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"At inclusion:- 1251 screened persons. - 445 high-risk persons. *- 806 collateral persons screened without \"high-risk\" status. * The short-term effectiveness of the lifestype intervention was evaluate on a total of 439 high-risk subjects (see: Favier et al. Rev Med Ass Maladie 2005). However, six non eligible persons had participated to the intervention: 4 collateral individuals (without high-risk status), plus two high-risk individuals aged 41 and 45 respectively. Although these participants were excluded from the short-term effectiveness analysis according to population selection criteria, we decided to include them in the follow-up process and to classified them in the intervention group to follow the intention-to-treat principle in the analysis of the long-term effectiveness of the lifestyle intervention, leading to 445 high-risk subjects included in the REDIA-prev1 Cohort Study."},"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\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","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":"19-09-2014","lastUpdatedAuto":null,"lastUpdatedManual":"02-06-2025","isContributorPI":"Non","contributorName":"Adrian FIANU","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Non"},"collaborations":{"networkConsortium":"Oui"},"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":"1\u00e8re visite \u00e0 domicile : examen m\u00e9dical r\u00e9alis\u00e9 par une infirmi\u00e8re de recherche (dur\u00e9e approximative = 30 mn). 2\u00e8me visite \u00e0 domicile : dans un d\u00e9lai de quelques jours \u00e0 quelques semaines apr\u00e8s la premi\u00e8re visite, enqu\u00eate sur l'histoire du mode de vie depuis la fin de l'essai, et les connaissances li\u00e9es \u00e0 la sant\u00e9 (dur\u00e9e inf\u00e9rieure \u00e0 60 min), par une di\u00e9t\u00e9ticienne (dur\u00e9e: 60 mn).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Couverture g\u00e9ographique : deux groupes d'habitants s\u00e9lectionn\u00e9s dans des quartiers vuln\u00e9rables, en difficult\u00e9s socio-\u00e9conomiques, de la commune de Saint-Pierre \u00e0 La R\u00e9union, Basse-Terre\/JoliFond (groupe intervention) et Ravine des Cabris (groupe t\u00e9moin)."},"dataTypes":{"clinicalDataDetails":"D\u00e9pistage des facteurs de risque du DT2 \u00e0 domicile. Mesures anthropom\u00e9triques : poids, stature (calcul de l'indice de masse corporelle - IMC), tour de taille, masse grasse par imp\u00e9dancem\u00e8trie (TANITA). Mesures de tension art\u00e9rielle (x2). Recueil d'ant\u00e9c\u00e9dents personnels, d'ant\u00e9c\u00e9dents familiaux (diab\u00e8te) et du mode de vie.","biologicalDataDetails":"Statut \u00e0 jeun requis : bilan lipidique (cholest\u00e9rol total, cholest\u00e9rol HDL, triglyc\u00e9rides), bilan glyc\u00e9mique (dont HbA1c) et insulin\u00e9mique. Test urinaire (prot\u00e9inurie, microalbuminurie).","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}