Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-07 @ 2:23 PM
Study NCT ID:
NCT06626360
Status:
RECRUITING
Last Update Posted:
2024-11-08
First Post:
2024-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Malnutrition in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malnutrition', 'timeFrame': '9 months', 'description': 'Malnutrition will be assessed by a working definition based on the GLIM-criteria and a Delphi-study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Malnutrition'], 'conditions': ['Overweight and Obese Adults', 'Malnutrition or Risk of Malnutrition']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis project has the following objectives:\n\n* 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).\n* 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).\n\nBased on this, to develop a screening tool for malnutrition in overweight; (WP4).\n\n\\- Dissemination of the results (WP5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital in- and outpatients with overweight or obesity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Overweight (BMI of 25 kg/m² or higher)\n\nExclusion Criteria:\n\n* Physically or mentally unable to participate.\n* Severe cognitive disorder or severe emotional instability, as assessed by the attending nurse or physician.\n* Insufficient proficiency in the Dutch language to express themselves properly and no interpreter or assistant to help.\n* Patient resides in a nursing or care home.'}, 'identificationModule': {'nctId': 'NCT06626360', 'acronym': 'SCOOP', 'briefTitle': 'Screening for Malnutrition in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'HAN University of Applied Sciences'}, 'officialTitle': 'SCreening fOr Malnutrition and Obesity in Patients With COVID-19 and Other Diseases', 'orgStudyIdInfo': {'id': 'SCOOP'}, 'secondaryIdInfos': [{'id': '6496655', 'type': 'OTHER_GRANT', 'domain': 'ZonMw'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with overweight or obesity', 'description': 'Inclusion criteria:\n\n* Age 18 years or older\n* Overweight (BMI of 25 kg/m² or higher)\n\nExclusion criteria:\n\n* Physically or mentally unable to participate.\n* Severe cognitive disorder or severe emotional instability, as assessed by the attending nurse or physician.\n* Insufficient proficiency in the Dutch language to express themselves properly and no interpreter or assistant to help.\n* Patient resides in a nursing or care home.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Carliene van Dronkelaar, PhD', 'role': 'CONTACT'}], 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Ede', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Emmelyne Vasse, PhD', 'role': 'CONTACT'}], 'facility': 'Ziekenhuis Gelderse Vallei', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Joanne Olieman, PhD', 'role': 'CONTACT'}], 'facility': 'ErasmusMC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Marian A de van der Schueren, PhD', 'role': 'CONTACT', 'email': 'marian.devanderschueren@han.nl', 'phone': '+31-024-353-0500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data first need to be analysed and published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HAN University of Applied Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amsterdam University of Applied Sciences', 'class': 'OTHER'}, {'name': 'National Institute for Public Health and the Environment (RIVM)', 'class': 'OTHER_GOV'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Wageningen University and Research', 'class': 'OTHER'}, {'name': 'Gelderse Vallei Hospital', 'class': 'OTHER'}, {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, {'name': 'Amsterdam UMC, location AMC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition, Dietetics and Lifestyle', 'investigatorFullName': 'dr. Marian de van der Schueren', 'investigatorAffiliation': 'HAN University of Applied Sciences'}}}}