Screening for Malnutrition in Obese Patients

NCT ID: NCT06626360

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-02

Study Completion Date

2025-08-31

Brief Summary

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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

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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).

Conditions

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Overweight and Obese Adults Malnutrition or Risk of Malnutrition

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amsterdam University of Applied Sciences

OTHER

Sponsor Role collaborator

National Institute for Public Health and the Environment (RIVM)

OTHER_GOV

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Wageningen University and Research

OTHER

Sponsor Role collaborator

Gelderse Vallei Hospital

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Amsterdam UMC, location AMC

OTHER

Sponsor Role collaborator

HAN University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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dr. Marian de van der Schueren

Professor of Nutrition, Dietetics and Lifestyle

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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OLVG

Amsterdam, , Netherlands

Site Status RECRUITING

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Site Status RECRUITING

ErasmusMC

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Marian A de van der Schueren, PhD

Role: CONTACT

+31-024-353-0500

Facility Contacts

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Carliene van Dronkelaar, PhD

Role: primary

Emmelyne Vasse, PhD

Role: primary

Joanne Olieman, PhD

Role: primary

Other Identifiers

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6496655

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SCOOP

Identifier Type: -

Identifier Source: org_study_id

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