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Recruiting NCT06485960

Validation of the Experience Sampling Dietary Assessment Method

Observational Validation Study

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ESDAM validation.
Who it may be relevant to
Registry conditions: Validation Study. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Validation of the Experience Sampling Dietary Assessment Method (ESDAM)

Overview

A new dietary assessment method was developed based on the Experience Sampling Methodology. In order to use this newly developed Experience Sampling Dietary Assessment Method (ESDAM) in research and clinical practice as a valid and reliable method to measure dietary intake the ESDAM needs to be validated against objective biomarkers and reference methods.

Detailed description

The purpose of this research project is to advance nutritional research by delivering an improved, accurate, feasible and reliable method to assess dietary intake. Our newly developed approach to collate dietary intake based on experience sampling methodology (ESM) will serve this purpose.

Therefore, this research aims to validate the newly developed Experience Sampling Dietary Assessment Method (ESDAM) by assessing construct validity compared to blood and urine biomarkers representing dietary intake. This will eventually result in the newly developed dietary assessment method being evidence-based and validated and, thus, ready-to-use as a reliable method for research and clinical practice.

Therefore, the ESDAM will be validated against repeated 24-hour dietary recalls, the doubly-labelled water method, urinary nitrogen and blood biomarkers. The study has a duration of four weeks. The first two weeks will be used to collect baseline data including socio-demographic, biometric data and three 24-hour recalls to assess dietary intake. During the last two weeks the Experience Sampling Dietary Assessment Method will be evaluated against urine biomarkers (Doubly-labeled water and urinary nitrogen), blood biomarkers (erythrocyte membrane fatty acid composition, beta-carotenoids, polyphenols) together with continuous glucose monitoring and two wrist-worn motion sensor devices to track eating- related movements.

Interventions

  • Other ESDAM validation
    * 3\* 24-Hour Dietary Recalls * Experience Sampling Dietary Assessment Method (mobile application) * Continuous Blood Glucose Monitoring * Wrist- worn motion sensors * Doubly-labeled water administration * Blood drawings (Erythrocyte Membrane Fatty Acid composition, Carotenoids, polyphenols) * Urine sampling (Doubly-labeled water, urinary nitrogen)

Primary outcome measures

  • Daily dietary energy intake based on the Experience Sampling Dietary Assessment Method [Time frame: 2 weeks]
  • Daily dietary protein intake based on the Experience Sampling Dietary Assessment Method [Time frame: 2 weeks]
  • Daily energy expenditure derived from the doubly-labeled water method [Time frame: 2 weeks]
  • Daily dietary protein intake based on urinary nitrogen analysis [Time frame: 2 weeks]
Secondary outcome measures (5)
  • Dietary intake based on Experience Sampling Dietary Assessment Method [Time frame: 2 weeks]
  • Dietary intake based on 24-hour dietary recalls [Time frame: 2 weeks]
  • Serum Beta-carotenoid concentration [Time frame: 4 weeks]
  • Erythrocyte membrane fatty acid composition [Time frame: 4 weeks]
  • Plasma polyphenol concentration [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

  • Signed informed consent
  • Having a smartphone and being capable of using the smartphone and apps
  • Having a freezer at home
  • Sufficient knowledge of the Dutch language to understand and participate in the study
  • Having a stable body weight (body weight not changed by 5% last 3 months)
  • Not aiming to gain or lose weight during the study period

Exclusion criteria

  • Pregnant or lactating women
  • Not following a specific diet for medical reasons (i.e. coeliac disease)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • KU Leuven — Leuven

Publications

  • Verbeke J, Verbeke K, Van der Schueren B, Vangoitsenhoven R, Matthys C. Protocol of the validation of the experience sampling-based dietary assessment method (ESDAM) against doubly labeled water, urinary protein, and biomarkers. Nutr J. 2025 Nov 5;24(1):169. doi: 10.1186/s12937-025-01232-3. PMID 41194100

Identifiers

NCT: NCT06485960 · S68363 · C3/22/050

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗