Plain English Summary
Background and study aims
This study is part of a large multi-national diabetes prevention project which aims to identify the best lifestyle for the prevention of type 2 diabetes in a population of pre-diabetic overweight or obese individuals. The focus will be on diet (specifically protein and glycemic index) and physical activity, as well as their interaction with the lifestyle factors, habitual stress and sleeping patterns as well as behavioural, environmental, cultural, and socioeconomic factors.
Who can participate?
People of all age ranges and genders who participated in five studies: 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).
What does the study involve?
Data is collected from the five studies, including dietary intake, in particular protein intake and glycemic index and load, physical activity and sleep duration, along with the prevalence and incidence of pre-diabetes, diabetes, and fasting blood sugar levels.
What are the possible benefits and risks of participating?
This study will increase knowledge on how specific lifestyle factors can help prevent type 2 diabetes. This study uses existing data from previous studies so there are no additional risks involved.
Where is the study run from?
Wageningen University (Netherlands)
When is the study starting and how long is it expected to run for?
January 2013 to December 2018
Who is funding the study?
1. 7th Framework Programme of the European Commission
2. Health Research Council of New Zealand
3. Ministry of Higher Education, Research and Science and Technology
4. Fonds Economische Structuurversterking
5. Samenwerkingsverband Noord Nederland
6. Ruimtelijk Economisch Programma
7. ZonMw
8. Academy of Finland
9. Social Insurance Institution of Finland
10. Turku University Foundation
11. Juho Vainion Säätiö
12. Research funds from the Turku, Tampere and Kuopio University Hospitals
13. Research foundation of Orion Corporation
14. Finnish Foundation of Cardiovascular Research
15. Suomen Lääketieteen Säätiö
16. Suomen Kulttuurirahasto
17. Ministry of Health, New Zealand
18. University of Otago
19. Quebec Department of Education Funds for Research and Training of Scientists
20. Quebec Department of Sport and Leisure
21. Quebec Health Research Council
22. Health and Welfare Canada
23. Canadian Diabetes Association
24. Natural Sciences and Engineering Research Council of Canada
25. Medical Research Council Canada
26. Canadian Institutes of Health Research
27. Laval University
Who is the main contact?
Dr Agnes Berendsen
Study website
Contact information
Type
Scientific
Contact name
Dr Agnes Berendsen
ORCID ID
http://orcid.org/0000-0003-3459-0603
Contact details
Wageningen University & Research
Division of Human Nutrition
PO Box 17
Wageningen
6708 WE
Netherlands
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
312057
Study information
Scientific title
PREVIEW Population studies (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World; Population studies)
Acronym
Study hypothesis
The primary goal of PREVIEW is to identify the most efficient lifestyle pattern for the prevention of type-2 diabetes in a population of pre-diabetic overweight or obese individuals. The focus will be on diet (specifically protein and glycemic index) and intensity of physical activity, as well as their interaction with the lifestyle factors, habitual stress and sleeping pattern as well as behavioural, environmental, cultural, and socioeconomic variables.
Ethics approval(s)
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.
Study design
Observational cross-sectional and longitudinal/cohort study including 5 cohorts with a follow-up ranging from 2 up to 5 years
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Community
Study type
Prevention
Patient information sheet
Not applicable
Condition
Pre-diabetes (for the prevention of type 2 diabetes)
Intervention
'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.
Intervention type
Mixed
Primary outcome measure
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
Secondary outcome measures
Glycemic index and food frequency questionnaire data collected by the five population studies between 1992 and 2013
Overall study start date
01/01/2013
Overall study end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All age ranges and both genders are included
Participant type(s)
Healthy volunteer
Age group
All
Sex
Both
Target number of participants
Combining all cohorts a total of 170,000 participants is targetted
Total final enrolment
78851
Participant 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
Recruitment start date
01/01/2013
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Australia, Canada, Finland, Netherlands, New Zealand
Study participating centre
Wageningen University
Wageningen
6700AA
Netherlands
Study participating centre
National Institute for Health and Welfare (Terveyden ja hyvinvoinnin laitos)
FI-00271
Finland
Study participating centre
The University of Sydney
Sydney
NSW 2006
Australia
Study participating centre
The University of Auckland
92019
New Zealand
Study participating centre
Universite Laval
QC G1V 0A6
Canada
Sponsor information
Organisation
Wageningen University and Research
Sponsor details
Stippeneng 4
PO Box 17
Wageningen
6708 WE
Netherlands
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programm, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, EU 7th Framework Programme, European Union 7th Framework Programme, Siebten Rahmenprogramm, Séptimo Programa Marco, Septième programme-cadre, Settimo programma quadro, 7th Framework Programme, Seventh EU Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Funder name
Health Research Council of New Zealand
Alternative name(s)
HRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
New Zealand
Funder name
Ministry of Higher Education, Research and Science and Technology (MESRST, PSR-SIIRI-837)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Fonds Economische Structuurversterking
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Samenwerkingsverband Noord Nederland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ruimtelijk Economisch Programma
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
ZonMw
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Netherlands
Funder name
Academy of Finland
Alternative name(s)
Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
Funding Body Type
government organisation
Funding Body Subtype
Universities (academic only)
Location
Finland
Funder name
Social Insurance Institution of Finland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Turku University Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Juho Vainion Säätiö
Alternative name(s)
Juho Vainio Foundation, Reppy Institute
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Finland
Funder name
Research funds from the Turku, Tampere and Kuopio University Hospitals
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research foundation of Orion Corporation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Finnish Foundation of Cardiovascular Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Suomen Lääketieteen Säätiö
Alternative name(s)
Finnish Medical Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Finland
Funder name
Suomen Kulttuurirahasto
Alternative name(s)
Finnish Cultural Foundation, SKR
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Finland
Funder name
Ministry of Health, New Zealand
Alternative name(s)
Manatu Hauora
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
New Zealand
Funder name
University of Otago
Alternative name(s)
Te Whare Wānanga o Otāgo, Te Whare Wānanga o Ōtākou
Funding Body Type
government organisation
Funding Body Subtype
Universities (academic only)
Location
New Zealand
Funder name
Quebec Department of Education Funds for Research and Training of Scientists
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Quebec Department of Sport and Leisure
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Quebec Health Research Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Health and Welfare Canada
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Canadian Diabetes Association
Alternative name(s)
Association Canadienne du Diabète, The Canadian Diabetes Association, CDA
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
Canada
Funder name
Natural Sciences and Engineering Research Council of Canada
Alternative name(s)
Conseil de Recherches en Sciences Naturelles et en Génie du Canada, NSERC, CRSNG
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Funder name
Medical Research Council Canada
Alternative name(s)
Medical Research Council, Canada, Medical Research Council, Medical Research Council of Canada, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Funder name
Universit&x00E9; Laval
Alternative name(s)
Laval University, ULaval, UL
Funding Body Type
government organisation
Funding Body Subtype
Universities (academic only)
Location
Canada
Results and Publications
Publication and dissemination plan
Main results will be published in peer-reviewed journals and presented at scientific conferences or symposia.
Intention to publish date
30/10/2017
Individual participant data (IPD) sharing plan
As the ‘PREVIEW Population studies’ makes use of existing data from different cohort studies the participant level data will be the property of and stored at the local study sites. Moreover, recruitment and analyses will continue for some cohort studies outside the scope of the ‘PREVIEW Population studies’ and so data cannot be made publicly available right now.
IPD sharing plan summary
Not expected to be made available
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/05/2019 | 08/05/2019 | Yes | No |
Protocol article | protocol and baseline results | 20/06/2017 | 17/05/2019 | Yes | No |
Protocol article | protocol and baseline results | 01/05/2018 | 17/05/2019 | Yes | No |