AzTrials
AzTrials

Dietary AssessmentNCT07459140

Evaluation of the Nutri-plus Module

A study testing The Nutri-plus module in people with Dietary Assessment, run by TNO at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In this validation study, the validity of the Nutri-plus module will be investigated. Read more about this study

Who is it for?
Ages 35 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Dietary Assessment
What is being tested?
The Nutri-plus module
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteNetherlands
Study dates
19 Oct 2022to 15 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Eligibility criteria included proficiency in the Dutch language, digital literacy, access to a laptop or PC, and consuming a typical Dutch diet. All answers to these criteria are self-reported and self-interpreted.

Who cannot join

  • Exclusion criteria included recent unintentional weight loss of more than 5 kg, treatment by a medical specialist for a (chronic) disease, a history of heart attack or stroke, planned or previous bariatric surgery, and pregnancy.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • TNO

    Leiden, South Holland, 2333 BE

Other trials in Netherlands

About this study

In this validation study, the validity of the Nutri-plus module will be investigated.

Read the detailed description

The Nutri+ module is part of the TNO 360-degree diagnostics tool. The aim of this tool is to generate a holistic perspective on an individual's health; that is, in addition to biomedical health, it also maps an individual's behavior, mental health, and socio-economic environment. This tool can be used for decision support and shared decision-making in, for example, primary care. Furthermore, based on this more holistic diagnostic approach, more personalized advice or better-tailored interventions can be offered to individuals.

However, the dietary questionnaire that is currently part of the 360-degree diagnostics tool is still fairly limited; it assesses consumption in only four food groups. In contrast, the Health Council distinguishes 15 product groups. As a result, the current 360-degree diagnostics tool provides an insufficient picture of an individual's dietary intake. In order to better assess dietary behavior within the 360-degree diagnostics and to provide more appropriate advice, the dietary questionnaire was further developed last year into the so-called "Nutri+ module."

The new questionnaire consists of 38 questions on an individual's dietary intake across 17 product groups. The questionnaire and cutoff values are based on the Guidelines for Healthy Diet, where applicable further refined using the recommendations of the Netherlands Nutrition Centre. After completing the questionnaire, a profile wheel (see Figure 1) is displayed, providing insight into compliance with the guidelines for 17 product groups. In this profile wheel, a "traffic light" color is used for each product group to indicate whether an individual roughly meets the guidelines (green), consumes more than 50% of the recommended amount (orange), or consumes less than 50% of the recommended amount (red). For (sub)product groups for which no guideline exists, a grey color is shown (for example, for potatoes).

The product groups defined by the Health Council were further refined to provide participants with more detailed insight into areas of their dietary pattern that could be improved. In addition, unhealthy choices are included in the Nutri+ module, even though they are not part of the Guidelines for Healthy Diet. By assessing and displaying these in the profile wheel, individuals can also gain insight into the extent of their unhealthy choices.

With the Nutri+ module, we aim to offer a dietary intake assessment as an integral part of the 360-degree tool, enabling individuals to gain insight into their own dietary patterns and areas for improvement. These outcomes can be used to provide personalized dietary advice or interventions tailored to the individual.

Before the Nutri+ module can be used for personalized dietary assessment and advice, it must be evaluated to determine whether it provides an accurate picture of an individual's dietary intake. To this end, the outcomes of the Nutri+ module, consisting of a red-orange-green categorization, can be compared with those of an already validated method for dietary intake assessment. In the literature, (weighed) dietary recall methods are commonly used to validate dietary questionnaires, as these methods are less sensitive to underreporting than food frequency questionnaires.

In a 24-hour recall method, individuals are asked to provide detailed information about all foods and beverages consumed in the previous 24 hours. To obtain a reliable estimate of habitual dietary intake, the 24-hour recall must be repeated on multiple days in order to correct for day-to-day variation. Wageningen University \& Research has developed and validated a Dutch online 24-hour dietary recall method that can be completed entirely online by participants, known as "Compl-Eat". This significantly reduces the costs and burden for both researchers and participants.

This study will consist of two phases. The first phase will involve a pre-test to assess the usability, comprehensibility, and completeness of the developed Nutri+ module among end users and experts. The insights generated will be used to further improve the Nutri+ module and the profile wheel visualization. After completion of the first phase, the second phase will commence, in which the Nutri+ module will be compared with a reference method in an evaluation study. The selected reference method for this evaluation study is a 24-hour recall using Compl-Eat.

Being tested
The Nutri-plus module
Keywords
Nutrition assessment, Validation study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Nutri-plus moduleBehavioural

    Filling out dietary intake in the Nutri-plus module and the reference method.

Study groups in NCT07459140
Study groupRoleWhat they receive
The Nutri-plus moduleExperimentalStarting with the Nutri-plus module, then the reference method.
Receives: Behavioral: The Nutri-plus module
The reference methodExperimentalStarting with the reference method, then the Nutri-plus module.
Receives: Behavioral: The Nutri-plus module

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute food group intake in grams

    Dietary intake for quantitative food groups (grams)

    Measured: Nutri-plus: 1 day per wave (each wave is 1 month). Reference: 4 days per wave (each wave is 1 month).

Secondary outcomes (4)
  1. Evaluation food group intake

    Evaluating reproducibility and classification

    Measured: Reproducibility: throughout the study, an average of 1 day (Nutri-plus) or 4 days (Reference) per wave (each wave is 1 month). Classification: through study completion, an average of 1 day (Nutri-plus) or 4 days (Reference).

  2. Calories (kcal)

    Number of calories (kcal) registered with reference method

    Measured: An average of 4 days per wave (each wave is 1 month).

  3. Calories (kcal)

    Number of calories (kcal) based on sex, age, weight, PAL

    Measured: An average of 4 days per sex, age group, weight group, and PAL category.

  4. Evaluation dietary assessment

    Evaluation of using the Nutri-plus module

    Measured: Through study completion, 1 day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start19 Oct 2022
  3. Primary completion11 Dec 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Participants were allocated to one of two schedules: starting with either the Nutri+ module or the reference method.
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07459140
Sponsor's protocol ID
2022-035
Status last verified
Mar 2026
First submitted
17 Feb 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prentice RL, Mossavar-Rahmani Y, Huang Y, Van Horn L, Beresford SA, Caan B, Tinker L, Schoeller D, Bingham S, Eaton CB, Thomson C, Johnson KC, Ockene J, Sarto G, Heiss G, Neuhouser ML. Evaluation and comparison of food records, recalls, and frequencies for energy and protein assessment by using recovery biomarkers. Am J Epidemiol. 2011 Sep 1;174(5):591-603. doi: 10.1093/aje/kwr140. Epub 2011 Jul 15.

    PubMed 21765003
  • Meijboom S, van Houts-Streppel MT, Perenboom C, Siebelink E, van de Wiel AM, Geelen A, Feskens EJM, de Vries JHM. Evaluation of dietary intake assessed by the Dutch self-administered web-based dietary 24-h recall tool (Compl-eat) against interviewer-administered telephone-based 24-h recalls. J Nutr Sci. 2017 Sep 19;6:e49. doi: 10.1017/jns.2017.45. eCollection 2017.

    PubMed 29152253
  • Kromhout D, Spaaij CJ, de Goede J, Weggemans RM. The 2015 Dutch food-based dietary guidelines. Eur J Clin Nutr. 2016 Aug;70(8):869-78. doi: 10.1038/ejcn.2016.52. Epub 2016 Apr 6.

    PubMed 27049034
  • Kalache A, de Hoogh AI, Howlett SE, Kennedy B, Eggersdorfer M, Marsman DS, Shao A, Griffiths JC. Nutrition interventions for healthy ageing across the lifespan: a conference report. Eur J Nutr. 2019 Jun;58(Suppl 1):1-11. doi: 10.1007/s00394-019-02027-z.

    PubMed 31254092
  • Harakeh Z, de Hoogh IM, van Keulen H, Kalkman G, van Someren E, van Empelen P, Otten W. 360 degrees Diagnostic Tool to Personalize Lifestyle Advice in Primary Care for People With Type 2 Diabetes: Development and Usability Study. JMIR Form Res. 2023 Mar 7;7:e37305. doi: 10.2196/37305.

    PubMed 36881463
  • Cade J, Thompson R, Burley V, Warm D. Development, validation and utilisation of food-frequency questionnaires - a review. Public Health Nutr. 2002 Aug;5(4):567-87. doi: 10.1079/PHN2001318.

    PubMed 12186666

Questions about this trial

What is this clinical trial studying?

A study testing The Nutri-plus module in people with Dietary Assessment, run by TNO at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute food group intake in grams (time frame: Nutri-plus: 1 day per wave (each wave is 1 month). Reference: 4 days per wave (each wave is 1 month).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07459140, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in