ClinicalTrials.gg
RecruitingNCT06626360SCOOPUpdated Nov 8, 2024

Screening for Malnutrition in Obese Patients

An observational study in Overweight and Obese Adults and Malnutrition or Risk of Malnutrition, sponsored by HAN University of Applied Sciences. Recruiting at 3 sites in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's title name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by HAN University of Applied Sciences · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study summary

More than half of the Dutch population is overweight or obese, which is associated with an increased risk of COVID-19 and worse outcomes during a COVID-19 infection. In addition, malnutrition and loss of muscle mass are often reported with COVID-19, as well as with cancer and other diseases. Malnutrition and overweight or obesity can coexist, even within the same individual. It is still unclear which mechanisms contribute to the worse outcomes of COVID-19 and other diseases in case of overweight, malnutrition, and a combination of both. The aim of this study is to identify which parameters are associated with worse disease outcomes through literature research and database research (COVID-19 and cancer, more than 150.000 participants). In addition, a clinical study will be conducted aiming to develop a simple screening tool for the recognition of the coexistence of malnutrition and overweight or obesity in clinical practice.

Read the detailed description

Overweight and malnutrition are both common and have a significant societal impact as well as a negative effect on healthcare. They can also coexist, and may potentially reinforce each other. How the combination of both influences the course of COVID-19 and other diseases is still largely unknown. There is no simple set of parameters yet available to screen for the simultaneous occurrence of overweight and malnutrition.

This project has the following objectives:

  • To evaluate the nutritional status (malnutrition, overweight, and the combination of both) and the (dietary) treatment of patients with COVID-19 in primary care (WP1).
  • To assess the influence of various parameters of malnutrition and overweight and their effects on the outcomes of COVID-19 and cancer based on literature and data from existing Dutch cohorts (WP2 and WP3).

Based on this, to develop a screening tool for malnutrition in overweight; (WP4).

  • Dissemination of the results (WP5).
02

Conditions studied

  • Overweight and Obese Adults
  • Malnutrition or Risk of Malnutrition

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Keywords

  • Overweight
  • Obesity
  • Malnutrition
03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

HAN University of Applied Sciences is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Hospital in- and outpatients with overweight or obesity

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older
  • Overweight ( of 25 kg/m² or higher)

Exclusion criteria

Exclusion Criteria:

  • Physically or mentally unable to participate.
  • Severe cognitive disorder or severe emotional instability, as assessed by the attending nurse or physician.
  • Insufficient proficiency in the Dutch language to express themselves properly and no interpreter or assistant to help.
  • Patient resides in a nursing or care home.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with overweight or obesity

    Inclusion criteria: * Age 18 years or older * Overweight (BMI of 25 kg/m² or higher) Exclusion criteria: * Physically or mentally unable to participate. * Severe cognitive disorder or severe emotional instability, as assessed by the attending nurse or physician. * Insufficient proficiency in the Dutch language to express themselves properly and no interpreter or assistant to help. * Patient resides in a nursing or care home.

06

What researchers measure

Primary outcomes

  1. Malnutrition

    Malnutrition will be assessed by a working definition based on the GLIM-criteria and a Delphi-study

    Time frame: 9 months

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Data first need to be analysed and published

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06626360
Lead sponsor
HAN University of Applied Sciences
Collaborators
Amsterdam University of Applied Sciences, National Institute for Public Health and the Environment (RIVM), Erasmus Medical Center, Wageningen University and Research, Gelderse Vallei Hospital, Amsterdam UMC, location VUmc, Amsterdam UMC, location AMC
Responsible party
dr. Marian de van der Schueren (Professor of Nutrition, Dietetics and Lifestyle, HAN University of Applied Sciences) — Principal investigator
First posted
Oct 3, 2024
Start date
Oct 2, 2024
Primary completion
Apr 30, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Nov 8, 2024

Study contacts

Marian A de van der Schueren, PhD
Contact
marian.devanderschueren@han.nl
+31-024-353-0500

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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