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<docDscr>
  <citation>
    <titlStmt>
      <titl>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</titl>
      <IDNo>FRESH-PEF20903-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION" role="">Adrian FIANU</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                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            </titl>
      <altTitl>
                    REDIA-prev1 Cohort                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF20903-en            </IDNo>
      <IDNo agency="PEF">
                    20903                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF20903                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    François FAVIER                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION">
        <ExtLink title="ROR" URI="https://ror.org/004dan487" role="organisation id"/>
        <ExtLink title="SIREN" URI="200030013" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Adrian FIANU                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION">
        <ExtLink title="ROR" URI="https://ror.org/004dan487" role="organisation id"/>
        <ExtLink title="SIREN" URI="200030013" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="Research team: Team EQUITY from the CERPOP (UMR1295, joint research unit INSERM-Universit&#xE9; Paul Sabatier), at Toulouse" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE LA RECHERCHE (ANR)                    
                                    </fundAg>
      <fundAg>
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION                    
                                    </fundAg>
      <fundAg>
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </fundAg>
      <fundAg>
                                            SANTE PUBLIQUE FRANCE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION" email="francois.favier@chu-reunion.fr">
                    François;FAVIER
                                            <ExtLink title="ROR" URI="https://ror.org/004dan487" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="200030013" role="organisation id"/>
                                    </contact>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION" email="adrian.fianu@chu-reunion.fr">
                    Adrian;FIANU
                                            <ExtLink title="ROR" URI="https://ror.org/004dan487" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="200030013" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    adiposity</keyword>
      <keyword vocab="" vocabURI="">
                    lifestyle intervention</keyword>
      <keyword vocab="" vocabURI="">
                    vulnerable population</keyword>
      <keyword vocab="" vocabURI="">
                    physical activity</keyword>
      <keyword vocab="" vocabURI="">
                    glycemic status</keyword>
      <keyword vocab="" vocabURI="">
                    quasi-experimentation</keyword>
      <keyword vocab="" vocabURI="">
                    diet</keyword>
      <keyword vocab="" vocabURI="">
                    community approach</keyword>
      <keyword vocab="" vocabURI="">
                    primary prevention</keyword>
      <keyword vocab="" vocabURI="">
                    post-trial follow-up study</keyword>
      <keyword vocab="" vocabURI="">
                    long-term effectiveness</keyword>
      <keyword vocab="" vocabURI="">
                    transferability.</keyword>
      <topcClas vocab="health theme">
                        Endocrinology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D004704"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Type 2 diabetes mellitus                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
    </subject>
    <abstract contentType="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>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2001-01-01"/>
      <collDate event="end" date="2011-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>La Réunion</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe 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 &gt;= 30 kg/m²), or central adiposity (waist circumference &gt;= 100 cm for men, &gt;= 90 cm for women), or overweight status (BMI between 25 and 30 kg/m²) associated with at least one other T2DM risk factor *.     * High blood pressure treated or detected (&gt;= 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 &lt; 6.0%                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>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.</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>Recalling of subjects for follow-up visits</otherQualityStatement>
      <otherQualityStatement>information on personal data use. - Monitoring by a clinical research associate selected by the sponsor: after the first subject’s inclusion</otherQualityStatement>
      <otherQualityStatement>regularly according to the follow-up implementation and the observed protocol\'s deviations</otherQualityStatement>
      <otherQualityStatement>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 thématique Santé Publique Pôle Recherche Clinique in 2011 November. - Use of a consistency query: at the time of data entry. - Missing data management: when necessary</otherQualityStatement>
      <otherQualityStatement>use of subject contact for data completion in the closest timeframe. - Data management implementation before statistical analysis.</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Others</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Non-probability: Purposive or "judgement" sampling                                                            <concept vocab="CESSDA" vocabURI="Nonprobability.Purposive"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Population database for statistical purposes</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Educational tests/assessment of health knowledge (literacy, self-management, interpretation of medical information, etc.)                                                            <concept vocab="CESSDA" vocabURI="MeasurementsAndTests.Educational"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>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.</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
