Screening for Malnutrition in Obese Patients | NCT06626360

Studies
Screening for Malnutrition in Obese Patients

NCT06626360

Sponsor

HAN University of Applied Sciences

Status

Recruiting

Last Update Posted

Nov 8, 2024Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Overweight and Obese Adults
Malnutrition or Risk of Malnutrition

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
6496655	Other Grant/Funding Number	ZonMw

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2024Actual

Primary Completion Date

Apr 30, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Oct 2, 2024

First Submission Date that Met QC Criteria

Oct 2, 2024

First Posted Date

Oct 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2024

Last Update Posted Date

Nov 8, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

dr. Marian de van der Schueren, Professor of Nutrition, Dietetics and Lifestyle, HAN University of Applied SciencesPrincipal Investigator

Lead Sponsor

HAN University of Applied SciencesOTHER

Collaborators

Name	Class
Amsterdam University of Applied Sciences	OTHER
National Institute for Public Health and the Environment (RIVM)	OTHER_GOV
Erasmus Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hospital in- and outpatients with overweight or obesity

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marian A de van der Schueren, PhD	Contact	+31-024-353-0500		marian.devanderschueren@han.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OLVG	Recruiting	Amsterdam			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Data first need to be analysed and published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D044342	Malnutrition
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided