Screening for Malnutrition in Obese Patients (SCOOP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obese Adults; Malnutrition or Risk of Malnutrition

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).

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Marian A de van der Schueren, PhD; Phone Number: +31-024-353-0500; Email: marian.devanderschueren@han.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • OLVG
    • Contact: Carliene van Dronkelaar, PhD
  • Ede, Netherlands
    • Recruiting
    • Ziekenhuis Gelderse Vallei
    • Contact: Emmelyne Vasse, PhD
  • Rotterdam, Netherlands
    • Recruiting
    • ErasmusMC
    • Contact: Joanne Olieman, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Hospital in- and outpatients with overweight or obesity

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malnutrition	Malnutrition will be assessed by a working definition based on the GLIM-criteria and a Delphi-study	9 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Malnutrition
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Malnutrition; Overweight
• Other Study ID Numbers: SCOOP; 6496655 (Other Grant/Funding Number: ZonMw)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data first need to be analysed and published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No