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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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27 May 2019 |
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Main ID: |
ISRCTN31174892 |
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Date of registration:
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28/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PREVIEW Population studies (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World; Population studies)
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Scientific title:
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PREVIEW Population studies (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World; Population studies) |
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Date of first enrolment:
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01/01/2013 |
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Target sample size:
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170000 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN31174892 |
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Study type:
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Observational |
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Study design:
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Observational cross-sectional and longitudinal/cohort study including 5 cohorts with a follow-up ranging from 2 up to 5 years (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Canada
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Finland
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Netherlands
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New Zealand
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Agnes
Berendsen |
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Address:
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Wageningen University & Research
Division of Human Nutrition
PO Box 17
6708 WE
Wageningen
Netherlands |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All age ranges and both genders are included
Exclusion criteria: Participants will be excluded with missing data on baseline dietary intake, physical activity, or sleep and missing data on fasting plasma glucose level or HbA1c
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pre-diabetes (for the prevention of type 2 diabetes)
Nutritional, Metabolic, Endocrine
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Intervention(s)
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'PREVIEW Population studies' describes cross-sectional and longitudinal analyses from the five population studies included in PREVIEW: Lifelines (the Netherlands), the Nutrition Questionnaires plus (NQplus) study (the Netherlands), the Cardiovascular Risk in Young Finns Study (YFS; Finland), the New Zealand Adult Nutrition Survey 2008/09 (NZANS), and the Quebec Family Study (QFS; Canada). For Lifelines and NQplus baseline data and data from the first follow-up measurement will be used. For YFS, the 27-year follow-up from 2007-2008 was used as baseline and the 30-year follow-up in 2010-2012 as follow-up. NZANS was a cross-sectional survey and thus included in the cross-sectional analyses only. For QFS, phase 2 data acted as baseline and phase 3 data as follow-up, based on the quality of the dietary and physical activity assessment. Additionally, ca. 300 newly recruited participants in Phase 3 were included in the cross-sectional analyses.
Data in the PREVIEW study have been collected within the framework of independent population studies, with different protocols for data collection and distinct original research foci. Therefore, data harmonization was a major task of the study. Harmonized variables were created for all parameters of interest for the PREVIEW data-analysis.
Baseline dietary intake, in particular protein intake and glycemic index and glycemic load, physical activity data, and sleep duration will be related to the prevalence and incidence of pre-diabetes, diabetes, and levels of fasting plasma glucose or HbA1c.
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Primary Outcome(s)
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Prevalence and incidence of prediabetes and diabetes, collected by the five population studies at baseline between 1992 and 2013 and at follow-up between 1997 and 2018
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Secondary Outcome(s)
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Glycemic index and food frequency questionnaire data collected by the five population studies between 1992 and 2013
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Source(s) of Monetary Support
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Seventh Framework Programme, Health Research Council of New Zealand, Ministry of Higher Education, Research and Science and Technology (MESRST, PSR-SIIRI-837), Fonds Economische Structuurversterking , Samenwerkingsverband Noord Nederland , Ruimtelijk Economisch Programma , ZonMw, Academy of Finland, Social Insurance Institution of Finland , Turku University Foundation, Juho Vainion Säätiö, Research funds from the Turku, Tampere and Kuopio University Hospitals, Research foundation of Orion Corporation, Finnish Foundation of Cardiovascular Research, Suomen Lääketieteen Säätiö, Suomen Kulttuurirahasto, Ministry of Health, New Zealand, University of Otago, Quebec Department of Education Funds for Research and Training of Scientists , Quebec Department of Sport and Leisure , Quebec Health Research Council , Health and Welfare Canada , Canadian Diabetes Association, Natural Sciences and Engineering Research Council of Canada, Medical Research Council Canada, Canadian Institutes of Health Res
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Ethics review
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Status:
Approval date:
Contact:
Ethical approval was not necessary. The researchers did not have any access to personal information regarding the participants and all data that will be analyzed are based on harmonized variables and are completely anonymized. For the individual observational studies, all participants signed informed consent for the original study.
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2018 |
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URL:
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