PREVIEW Population studies (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World; Population studies)
| ISRCTN | ISRCTN31174892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31174892 |
| Secondary identifying numbers | 312057 |
- Submission date
- 25/09/2017
- Registration date
- 28/11/2017
- Last edited
- 17/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Wageningen University & Research
Division of Human Nutrition
PO Box 17
Wageningen
6708 WE
Netherlands
 ORCID ID |
0000-0003-3459-0603 |
|---|
Study information
| 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 |
| Scientific title | PREVIEW Population studies (PREVention of diabetes through lifestyle Intervention and population studies in Europe and around the World; Population studies) |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2018 |
Eligibility
| 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 |
| Key inclusion criteria | All age ranges and both genders are included |
| Key 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 |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Australia
- Canada
- Finland
- Netherlands
- New Zealand
Study participating centres
6700AA
Netherlands
Finland
NSW 2006
Australia
New Zealand
Canada
Sponsor information
University/education
Stippeneng 4
PO Box 17
Wageningen
6708 WE
Netherlands
| Website | www.wur.nl |
|---|---|
"ROR" |
https://ror.org/04qw24q55 |
Funders
Funder type
Government
Government organisation / National government
- 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
Government organisation / National government
- Alternative name(s)
- HRCNewZealand, HRC New Zealand, HRC
- Location
- New Zealand
No information available
No information available
No information available
No information available
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Juho Vainio Foundation, Reppy Institute
- Location
- Finland
No information available
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Finnish Medical Foundation
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Finnish Cultural Foundation, SKR
- Location
- Finland
Government organisation / National government
- Alternative name(s)
- Manatu Hauora, Ministry of Health - Manatū Hauora, minhealthnz
- Location
- New Zealand
Government organisation / Universities (academic only)
- Alternative name(s)
- Te Whare Wānanga o Otāgo, Te Whare Wānanga o Ōtākou
- Location
- New Zealand
No information available
No information available
No information available
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Association Canadienne du Diabète, The Canadian Diabetes Association, CDA
- Location
- Canada
Government organisation / National government
- Alternative name(s)
- Conseil de Recherches en Sciences Naturelles et en Génie du Canada, NSERC, CRSNG
- Location
- Canada
Government organisation / National government
- Alternative name(s)
- Medical Research Council, Canada, Medical Research Council, Medical Research Council of Canada, MRC
- Location
- Canada
Government organisation / National government
- 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
- Location
- Canada
Government organisation / Universities (academic only)
- Alternative name(s)
- Laval University, ULaval, Universitas Laval, UL
- Location
- Canada
Results and Publications
| Intention to publish date | 30/10/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Main results will be published in peer-reviewed journals and presented at scientific conferences or symposia. |
| 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. |
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 |
Editorial Notes
17/05/2019: Publication references added.
08/05/2019: Total final enrolment and publication reference were added.
