Clinical trial NCT06626360: Screening for Malnutrition in Obese Patients
Official title: SCreening fOr Malnutrition and Obesity in Patients With COVID-19 and Other Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overweight and Obese Adults
Malnutrition or Risk of Malnutrition
Keywords: Overweight
Obesity
Malnutrition
Lead sponsor: HAN University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Amsterdam University of Applied Sciences
name: National Institute for Public Health and the Environment (RIVM)
name: Erasmus Medical Center
name: Wageningen University and Research
name: Gelderse Vallei Hospital
name: Amsterdam UMC, location VUmc
name: Amsterdam UMC, location AMC
First posted: 2024-10-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital in- and outpatients with overweight or obesity

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Malnutrition
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Rotterdam
country: Netherlands
facility: ErasmusMC
Study officials:
References: