Screening for Malnutrition in Obese Patients

NCT06626360 | Recruiting

• 2 other identifiers: SCOOP6496655
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Overweight and Obese Adults; Malnutrition or Risk of Malnutrition

Keywords

Overweight; Obesity; Malnutrition

Outcome Measures

Primary Outcomes (1)

• Malnutrition

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

  9 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospital in- and outpatients with overweight or obesity

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

OLVG

Amsterdam, Netherlands

RECRUITING

Ziekenhuis Gelderse Vallei

Ede, Netherlands

RECRUITING

ErasmusMC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Overweight; Malnutrition; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marian A de van der Schueren, PhD

CONTACT

+31-024-353-0500; marian.devanderschueren@han.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition, Dietetics and Lifestyle

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 3, 2024
• Study Start: October 2, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 31, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)