Nutrition Questionnaires and more
| ISRCTN | ISRCTN39625297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39625297 |
| Protocol serial number | NL34775.081.10 |
| Sponsor | Wageningen University & Research |
| Funders | ZonMw, Grant 91110030, Grant 115100007, NWO, Netherlands Organisation for Scientific Research, EU (PreView Grant 31 2057, Grant BBMRI-NL RP9 and CP2011-38) |
- Submission date
- 06/03/2018
- Registration date
- 24/04/2018
- Last edited
- 24/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
During the past decades our lifestyle has changed considerably, as shown by for instance a decrease in physical activity levels and changes in dietary habits. With that, the number of people with obesity and cardiometabolic conditions is rising. To pin-point the specific dietary factors that may be responsible for the rise in obesity and adverse cardiometabolic health outcomes, we initiated the Nutrition Questionnaires plus (NQplus) study, a prospective cohort study initiated by researchers of the division of Human Nutrition of Wageningen University.
Food Frequency Questionnaires (FFQ) are commonly applied to collect dietary intake information. Ideally, an FFQ is generated using information on dietary intake of a large representative sample. The Dutch FFQ tool now uses information of the Dutch National Food Consumption Survey 1998, but this is not only outdated, it also lacks sufficient information on the individual variation of intake and food patterns. Also, objective information as obtained from biochemical markers is needed to be able to evaluate the occurrence of under- and overreporting.
Who can participate?
Men and women, aged 20-70 years, living in the regions Ede, Arnhem, Wageningen, Renkum, Veenendaal en Tiel.
What does the study involve?
This study is a cohort study, so no interventions are involved. Baseline measurements included the assessment of habitual dietary intake (by FFQ and repeated 24-hour recalls), a physical examination (e.g. body composition, blood pressure, tonometry, AGE-measurement, and cognitive performance), venepuncture (taking a blood sample) (e.g. to determine total and HDL-cholesterol, triglycerides, glucose, carotenoids, tocopherols, fatty acids, vitamin D, MGP, and DNA profiles), 24-hour urine collection (e.g. for nitrogen, sodium, and potassium determination), and a variety of validated questionnaires (e.g. on demographics, body weight history, lifestyle, eating behaviour and mental health). All measurements are repeated after one and two years of follow-up.
In the first stage (sampling frame) people are asked to fill in a short questionnaire. In the second stage, subjects will be asked for a physical examination three or five times in 48 months, including venepuncture and 24-hr urine collection. Half of the group will fill in 13 web-based FFQs over 4 years. They have to collect their urine three times and undergo five web-based dietary
recalls. Participating in the second group of 750 subjects means completing nine 24-hr dietary recalls, 4 by phone and 5 web-based, over one year, and three in the last year of the study, and a total of 3 web-based FFQs over 4 years.
What are the possible benefits and risks of participating?
Venepuncture can occasionally cause a local hematoma or bruise and some participants may report pain or discomfort. Benefit for the individual participants is that they receive information on their BMI, blood pressure, total and HDL-cholesterol, triglycerides and glucose.
Where is the study run from?
The study was run from Wageningen University & Research, Wageningen, the Netherlands.
When is study starting and how long is it expected to run for?
This study started on 01/07/2011 and finished on 01/04/2015.
How long will the trial be recruiting participants for?
Recruitment lasted from 01/07/2011 to 01/03/2013.
Who is the main contact?
The contact for the NQPlus study is Edith Feskens.
Contact information
Scientific
Wageningen University & Research
Division of Human Nutrition
Wageningen
PO Box 17
Netherlands
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | The Nutrition Questionnaires plus study (NQplus) |
| Study acronym | NQplus |
| Study objectives | Updated questionnaires and testing provide improved tracking of dietary intake and analysis of relationships with obesity and cardiometabolic disease |
| Ethics approval(s) | Wageningen University ethics committee, 27/06/2011, NL34775.081.10 |
| Health condition(s) or problem(s) studied | obesity, cardiovascular disease. |
| Intervention | The NDARD-project aims to develop a database with dietary data that is collected by means of Food Frequency Questionnaires (FFQs), repeated 24-hour recalls, as well as urinary/blood biomarkers. These data allow the validation and development of new dietary assessment methods, based on methods that provide more information on the variation in dietary intake than the currently used DNFCS database. Hence, it is expected that FFQs generated with this new database will provide more accurate dietary data compared to the FFQs that are currently used. Given the unique nature of the dietary data collected in view of the NDARD-project, we decided to expand the NDARD-database by collecting extensive data on participant characteristics, including cross-sectional and longitudinal data on demographics, lifestyle, medical history, and (cardio-metabolic) health outcomes: the Nutrition Questionnaire plus (NQplus) study. This study provides the opportunity to explore a large number of interesting research questions related to diet and cardio-metabolic health outcomes using the best dietary intake assessment methods available so far. Associations that can be studied using NQplus data for instance include the potential role of polyphenol intake in relation to blood pressure and arterial stiffness, Na/K excretion in relation to blood pressure, arterial stiffness, and metabolic syndrome, associations between dietary lignans and serum lipids, associations between timing of eating and metabolic health, as well as the association between vitamin D, glucose intolerance, and cognition. The NQplus study is a large prospective cohort study, primarily conducted among Caucasian Dutch adults aged 20-70 years living in the central part of the Netherlands (i.e. Wageningen and vicinity), initiated as an add-on study to the NDARD-project (Brouwer-Brolsma, submitted for publication). The NQplus study aimed to include 1,750 men and women that were able to speak and write Dutch and competent to make their own decisions. Participants were recruited via: 1) random sampling from the municipality registries of Ede, Wageningen, Renkum (n=30,000), and Arnhem (n=15,000) by sending electronic invitations; and 2) sending invitation letters to all households of Veenendaal (n=25,000). 2,048 men and women were included in the study. Baseline measurements included the assessment of habitual dietary intake by an FFQ and repeated 24-hour recalls, physical examination, venepuncture, 24-hour urine collection, and a variety of validated health and lifestyle questionnaires. All measurements were repeated at 1 and 2 years of follow-up, and were performed according to a standardized protocol by trained research assistants. All participants gave written informed consent before commencement of the study. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Dietary intake: Assessment of habitual dietary intake was done by means of an 180-item semi-quantitative FFQ and up to nine repeated 24-hour recalls. All measurements were repeated at one and two years of follow-up. |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 31/12/2030 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 2048 |
| Key inclusion criteria | 1. Able to speak and write Dutch 2. Competent to make their own decisions |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/07/2011 |
| Date of final enrolment | 01/03/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |