{"doc_desc":{"title":"Follow-up of the participants to an intervention controlled trial for the primary prevention of type-2 diabetes mellitus and metabolic syndrome on Reunion Island","idno":"FRESH-PEF20903-en","producers":[{"name":"Adrian FIANU","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF20903-en","IDno":{"metadata_no":[{"agency":"PEF","code":"20903"},{"agency":"FReSH","code":"FRESH-PEF20903"}]},"title":"Follow-up of the participants to an intervention controlled trial for the primary prevention of type-2 diabetes mellitus and metabolic syndrome on Reunion Island","alternate_title":"REDIA-prev1 Cohort"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Fran\u00e7ois;FAVIER","firstname":"Fran\u00e7ois","lastname":"FAVIER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/004dan487","role":"organisation id"},{"title":"SIREN","uri":"200030013","role":"organisation id"}],"email":"francois.favier@chu-reunion.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","PILabo":"CHU de La R\u00e9union \/ CENTRE D'INVESTIGATION CLINIQUE DE LA R\u00c9UNION (CIC 1410) INSERM \/ CHU","isContact":true},{"name":"Adrian;FIANU","firstname":"Adrian","lastname":"FIANU","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/004dan487","role":"organisation id"},{"title":"SIREN","uri":"200030013","role":"organisation id"}],"email":"adrian.fianu@chu-reunion.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","PILabo":"CHU de La R\u00e9union \/ CENTRE D'INVESTIGATION CLINIQUE DE LA R\u00c9UNION (CIC 1410) INSERM \/ CHU","isContact":true}],"oth_id":[{"name":"Research team: Team EQUITY from the CERPOP (UMR1295, joint research unit INSERM-Universit\u00e9 Paul Sabatier), at Toulouse","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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":""}]},"distribution_statement":{"contact":[{"name":"Fran\u00e7ois;FAVIER","lastname":"FAVIER","firstname":"Fran\u00e7ois","type":"contact","email":"francois.favier@chu-reunion.fr","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","lastname":"FIANU","firstname":"Adrian","type":"contact","email":"adrian.fianu@chu-reunion.fr","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":"adiposity"},{"keyword":"lifestyle intervention"},{"keyword":"vulnerable population"},{"keyword":"physical activity"},{"keyword":"glycemic status"},{"keyword":"quasi-experimentation"},{"keyword":"diet"},{"keyword":"community approach"},{"keyword":"primary prevention"},{"keyword":"post-trial follow-up study"},{"keyword":"long-term effectiveness"},{"keyword":"transferability."}],"topics":[{"topic":"Endocrinology","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":"Type 2 diabetes mellitus","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/119724091","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"}],"purpose":"Primary objective: to evaluate the long-term effectiveness of an intervention promoting a healthy diet and the practice of a moderate regular physical activity, on body weight and adiposity (waist circumference, fat mass), in Type-2 diabetes mellitus (T2DM) high-risk young adults. Secondary objectives: - To compare body weight change and adiposity change between groups (intervention versus control) in the entire cohort including all screened persons (with high-risk status or not). - To compare diet and physical activity reported at follow-up, between groups, then according to the intervention adherence. - To compare incidence of screened glycemic impairments between groups and according to the baseline risk level. - To describe change in knowledge and beliefs on both T2DM and obesity (KABP).","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"The target population eligible to the lifestyle intervention trial was composed of men and women (non-pregnant), aged 18-40, with no serious illness (e.g., diabetes, cardiovascular disease, cancer) nor disability (incompatible with physical activity practice), living in the studied districts, and screened at home as high-risk subjects.  This high-risk status was based on a combination of T2DM risk factors: overall obesity (BMI >= 30 kg\\\/m\u00b2), or central adiposity (waist circumference >= 100 cm for men, >= 90 cm for women), or overweight status (BMI between 25 and 30 kg\\\/m\u00b2) associated with at least one other T2DM risk factor *.     * High blood pressure treated or detected (>= 140\\\/90 mm Hg), elevated glycated hemoglobin (HbA1c between 5.5% and 6.0%), family history of diabetes at first degree, and for women, having a child weighting more than 4 kg at birth and \\\/or an history of gestational diabetes.   Screened subjects without high-risk status were thus not obese (and if overweight with no other T2DM risk factors from those listed above). These collateral persons had been included in the follow-up process besides the high-risk subjects, but they did not participate to the long-term effectiveness evaluation analysis (primary objective of this research).   All subjects were screened as non-diabetic based on glycated hemoglobin (HbA1c) measure < 6.0%\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"['BMI: body mass index WHO cut-off for adults. Items of the physical activity questionnaire of Baecke et al. Am J Clin Nutr 1982. Food consumption: estimation of food servings photo album INSERM E3N team. PCS (professions and professional categories): INSEE nomenclature.']","committee":"","governance":""}],"other_quality_statement":"['Recalling of subjects for follow-up visits, information on personal data use. - Monitoring by a clinical research associate selected by the sponsor: after the first subject\u2019s inclusion, regularly according to the follow-up implementation and the observed protocol\\'s deviations, at the end of the study. - Audit \/ inspection: at each step of the study and until 15 years after study completion. A inter CIC\\'s Audit was conducted by the INSERM Institut th\u00e9matique Sant\u00e9 Publique P\u00f4le Recherche Clinique in 2011 November. - Use of a consistency query: at the time of data entry. - Missing data management: when necessary, use of subject contact for data completion in the closest timeframe. - Data management implementation before statistical analysis.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Nonprobability.Purposive\",\"vocab\":\"CESSDA\"},\"value\":\"Non-probability: Purposive or \\\"judgement\\\" sampling\"}']","sample_frame":{"frame_unit":{"unit_type":"['Population database for statistical purposes']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Educational\",\"vocab\":\"CESSDA\"},\"value\":\"Educational tests\/assessment of health knowledge (literacy, self-management, interpretation of medical information, etc.)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","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":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"19-09-2014","lastUpdatedAuto":null,"lastUpdatedManual":"02-06-2025","isContributorPI":false,"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":false},"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":"Home-visit # 1: medical examination by a research-skilled nurse (approximate duration = 30 min). Home-visit # 2: within a few days to a few weeks after the first visit, survey on history of lifestyle since trial completion, and knowledge related to health, by a dietician monitoring (60 min duration).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Geographical coverage: two groups of inhabitants, each one selected within a vulnerable district (defined by low SES) from the municipality of Saint-Pierre (on Reunion Island), Basse-Terre \/ JoliFond (intervention group) and Ravine des Cabris (control group)."},"dataTypes":{"clinicalDataDetails":"In-home screening of T2DM risk factors. Anthropometric measurements: body weight, height (for body mass index calculation), waist circumference, fat mass by impedancemetry (TANITA). Blood pressure measurements (x2). Data collection on personal history, diabetes familial history and lifestyle.","biologicalDataDetails":"Fasting required: lipid (total cholesterol, HDL cholesterol, triglycerides), glucose balance (including HbA1c) and insulinaemic. Urine test (proteinuria, microalbuminuria).","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}