NCT07459140

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 17, 2026

Last Update Submit

March 6, 2026

Conditions

Keywords

Nutrition assessmentValidation study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Evaluation food group intake

    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)

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

  • Calories (kcal)

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

  • Evaluation dietary assessment

    Through study completion, 1 day.

Study Arms (2)

The Nutri-plus module

EXPERIMENTAL

Starting with the Nutri-plus module, then the reference method.

Behavioral: The Nutri-plus module

The reference method

EXPERIMENTAL

Starting with the reference method, then the Nutri-plus module.

Behavioral: The Nutri-plus module

Interventions

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

The Nutri-plus moduleThe reference method

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TNO

Leiden, South Holland, 2333 BE, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 21765003BACKGROUND
  • 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.

    PMID: 29152253BACKGROUND
  • 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.

    PMID: 27049034BACKGROUND
  • 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.

    PMID: 31254092BACKGROUND
  • 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.

    PMID: 36881463BACKGROUND
  • 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.

    PMID: 12186666BACKGROUND

Related Links

Study Officials

  • Suzan Wopereis

    TNO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants were allocated to one of two schedules: starting with either the Nutri+ module or the reference method.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2026

First Posted

March 9, 2026

Study Start

October 19, 2022

Primary Completion

December 11, 2022

Study Completion

December 15, 2022

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations