Overweight and Obese AdultsSCOOPNCT06626360
Screening for Malnutrition in Obese Patients
An observational study of Overweight and Obese Adults and Malnutrition or Risk of Malnutrition, run by HAN University of Applied Sciences at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obese Adults, Malnutrition or Risk of Malnutrition
- How many people
- 2,000 participants
- Where
- 3 sitesNetherlands
- Study dates
- 2 Oct 2024to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital in- and outpatients with overweight or obesity
Who may be able to join
- Age 18 years or older
- Overweight (BMI of 25 kg/m² or higher)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
OLVG
Amsterdam
Carliene van Dronkelaar, PhD
- Recruiting
Ziekenhuis Gelderse Vallei
Ede
Emmelyne Vasse, PhD
- Recruiting
ErasmusMC
Rotterdam
Joanne Olieman, PhD
About this study
Official title: 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.
Read the 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).
- Keywords
- Overweight, Obesity, Malnutrition
- Medical subject headings
- Overweight, Malnutrition, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition
Malnutrition will be assessed by a working definition based on the GLIM-criteria and a Delphi-study
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start2 Oct 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and Obese AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HAN University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam University of Applied Sciences, National Institute for Public Health and the Environment (RIVM), Erasmus Medical Center, Wageningen University and Research, Gelderse Vallei Hospital, Amsterdam UMC, location VUmc, Amsterdam UMC, location AMC
- Responsible party
- Principal investigator, dr. Marian de van der Schueren, HAN University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626360
- Sponsor's protocol ID
- SCOOP
- Other IDs
- 6496655
- Acronym
- SCOOP
- Status last verified
- Nov 2024
- First submitted
- 2 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data first need to be analysed and published
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCreening fOr Malnutrition and Obesity in Patients With COVID-19 and Other Diseases
- ClinicalTrials.gov ID
- NCT06626360
- Acronym / sponsor ID
- SCOOP / SCOOP
- Keywords
- Overweight, Obesity, Malnutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- HAN University of Applied SciencesUniversity, hospital or other
- Collaborators
- Amsterdam University of Applied Sciences, National Institute for Public Health and the Environment (RIVM), Erasmus Medical Center, Wageningen University and Research, Gelderse Vallei Hospital, Amsterdam UMC, location VUmc, Amsterdam UMC, location AMC
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital in- and outpatients with overweight or obesity
Key inclusion criteria (2 listed)
- Age 18 years or older
- Overweight (BMI of 25 kg/m² or higher)
Key exclusion criteria (4 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Malnutrition
Time frame: 9 months
Malnutrition will be assessed by a working definition based on the GLIM-criteria and a Delphi-study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No. Data first need to be analysed and published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obese Adults and Malnutrition or Risk of Malnutrition, run by HAN University of Applied Sciences at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marian A de van der Schueren, PhD (+31-024-353-0500, marian.devanderschueren@han.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malnutrition (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.