ISRCTN - ISRCTN31174892: PREVIEW Population studies (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World; Population studies)

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

Trial website

http://www.previewstudy.com/

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Community

Trial 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

Phase

Drug names

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 trial start date

01/01/2013

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All age ranges and both genders are included

Participant type

Healthy volunteer

Age group

All

Gender

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

Sponsor information

Organisation

Wageningen University and Research

Sponsor details

Stippeneng 4
PO Box 17
Wageningen
6708 WE
Netherlands

Sponsor type

University/education

Website

www.wur.nl

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, 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

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 publically funded and privately funded)

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.

IPD sharing statement
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.

Intention to publish date

30/10/2017

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2017 protocol and baseline results in: https://www.ncbi.nlm.nih.gov/pubmed/28632180 (added 17/05/2019)
2018 protocol and baseline results in: https://www.ncbi.nlm.nih.gov/pubmed/29322617 (added 17/05/2019)
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31051510 (added 08/05/2019)

Publication citations

Additional files

Editorial Notes

17/05/2019: Publication references added. 08/05/2019: Total final enrolment and publication reference were added.