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NCT Number: NCT06626360

Screening for Malnutrition in Obese Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLVG, Amsterdam, Netherlands

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Malnutrition

    Time frame: 9 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marian A de van der Schueren, PhD

CONTACT

[email protected]

+31-024-353-0500

Sponsors and collaborators

Lead sponsor

HAN University of Applied Sciences

Other

Collaborators

  • Amsterdam UMC, location AMC
  • Amsterdam UMC, location VUmc
  • Amsterdam University of Applied Sciences
  • Erasmus Medical Center
  • Gelderse Vallei Hospital
  • National Institute for Public Health and the Environment (RIVM)
  • Wageningen University and Research

Registry information

Official study title

SCreening fOr Malnutrition and Obesity in Patients With COVID-19 and Other Diseases

Acronym: SCOOP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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