Evaluation of the Nutri-plus Module

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

Study Overview

• Status: Completed
• Conditions: Dietary Assessment
• Intervention / Treatment: Behavioral: The Nutri-plus module

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • South Holland
    • Leiden, South Holland, Netherlands, 2333 BE
      • TNO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Nutri-plus module; Starting with the Nutri-plus module, then the reference method.	Behavioral: The Nutri-plus module; Filling out dietary intake in the Nutri-plus module and the reference method.
Experimental: The reference method; Starting with the reference method, then the Nutri-plus module.	Behavioral: The Nutri-plus module; Filling out dietary intake in the Nutri-plus module and the reference method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute food group intake in grams	Dietary intake for quantitative food groups (grams)	Nutri-plus: 1 day per wave (each wave is 1 month). Reference: 4 days per wave (each wave is 1 month).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation food group intake	Evaluating reproducibility and classification	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	An average of 4 days per wave (each wave is 1 month).
Calories (kcal)	Number of calories (kcal) based on sex, age, weight, PAL	An average of 4 days per sex, age group, weight group, and PAL category.
Evaluation dietary assessment	Evaluation of using the Nutri-plus module	Through study completion, 1 day.

Collaborators and Investigators

• Sponsor: TNO
• Investigators: Principal Investigator: Suzan Wopereis, TNO

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Dutch Dietary Guidelines

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): December 11, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Validation study; Nutrition assessment
• Other Study ID Numbers: 2022-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No