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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Dietary Assessment
- 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 group | Role | What they receive |
|---|---|---|
| The Nutri-plus module | Experimental | Starting with the Nutri-plus module, then the reference method. Receives: Behavioral: The Nutri-plus module |
| The reference method | Experimental | Starting 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.
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)
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).
Calories (kcal)
Number of calories (kcal) registered with reference method
Measured: An average of 4 days per wave (each wave is 1 month).
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.
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.
- First posted9 Mar 2026
- Study start19 Oct 2022
- Primary completion11 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dietary AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzan Wopereis, Principal investigator, TNO
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 21765003Meijboom 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 29152253Kromhout 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 27049034Kalache 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 31254092Harakeh 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 36881463Cade 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Nutri-plus Module
- ClinicalTrials.gov ID
- NCT07459140
- Acronym / sponsor ID
- 2022-035
- Conditions
- Dietary Assessment
- Keywords
- Nutrition assessment, Validation study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this validation study, the validity of the Nutri-plus module will be investigated.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were allocated to one of two schedules: starting with either the Nutri+ module or the reference method.
| Arm | Type | Receives |
|---|---|---|
| The Nutri-plus module | Experimental | Behavioral: The Nutri-plus moduleStarting with the Nutri-plus module, then the reference method. |
| The reference method | Experimental | Behavioral: The Nutri-plus moduleStarting with the reference method, then the Nutri-plus module. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Nutri-plus moduleFilling out dietary intake in the Nutri-plus module and the reference method. | Behavioural | The Nutri-plus module, The reference method |
Primary outcome
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).
Dietary intake for quantitative food groups (grams)
4 secondary outcomes
Evaluation food group intake
Time frame: 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).
Calories (kcal)
Time frame: An average of 4 days per wave (each wave is 1 month).
Calories (kcal)
Time frame: An average of 4 days per sex, age group, weight group, and PAL category.
Evaluation dietary assessment
Time frame: Through study completion, 1 day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 21765003Prentice 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.
- Background: PubMed 29152253Meijboom 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.
- Background: PubMed 27049034Kromhout 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.
- Background: PubMed 31254092Kalache 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.
- Background: PubMed 36881463Harakeh 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.
- Background: PubMed 12186666Cade 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.
- Dutch Dietary GuidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzan Wopereis principal investigator
TNO
1 site in 1 country: see every site and its status.
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.