Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-02 @ 1:24 AM
Study NCT ID:
NCT06905795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening and Intervention of MASLD in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-03-24', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Waist-to-Height Ratio at 12 Months', 'timeFrame': 'From enrollment to the end of treatment at 12 months'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Controlled Attenuation Parameters at 12 Months', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Controlled Attenuation Parameters will be detected by Fibroscan HANDY'}, {'measure': 'Change from Baseline in Liver Stiffness Measurement at 12 Months', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Liver Stiffness Measurement will be detected by Fibroscan HANDY'}, {'measure': 'Change from Baseline in Blood Lipids at 12 Months.', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Include TC, TG, LDL-C, and HDL-C.'}, {'measure': 'Change from Baseline in Fasting Blood-Glucose at 12 Months', 'timeFrame': 'From enrollment to the end of treatment at 12 months'}, {'measure': 'Change from Baseline in Fasting Insulin at 12 Months', 'timeFrame': 'From enrollment to the end of treatment at 12 months'}, {'measure': 'Change from Baseline in Liver Enzyme at 12 Months', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Inlude ALT, AST, and GGT.'}, {'measure': 'Change from Baseline in BMI at 12 Months', 'timeFrame': 'From enrollment to the end of treatment at 12 months'}, {'measure': 'Change from Baseline in BMI Z score at 12 Months', 'timeFrame': 'From enrollment to the end of treatment at 12 months'}, {'measure': 'Change from Baseline in Cardiorespiratory Endurance at 12 Months', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Cardiorespiratory Endurance will be assessed by 20 meter shuttle run test.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'MASLD', 'Lifestyle intervention', 'Screening'], 'conditions': ['MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease', 'Children']}, 'descriptionModule': {'briefSummary': 'Non-alcoholic fatty liver disease (NAFLD) in children and adolescents has recently been renamed metabolic dysfunction-associated steatotic liver disease (MASLD). It has become one of the leading chronic liver diseases in children. The prevalence of MASLD is 6.3% among the general pediatric population and 40.4% among overweight and obese children, with an increasing trend each year. MASLD increases the risk of various metabolic diseases and can eventually lead to liver fibrosis or hepatocellular carcinoma, contributing to the disease burden.\n\nPrevious work by our project team using machine learning methods has identified that fasting insulin, alanine aminotransferase (ALT), and waist-to-height ratio (WHtR) have good predictive value in overweight and obese children, with a recommendation that children with a WHtR ≥ 0.48 should undergo further screening. However, external validation is still required to improve the effectiveness and cost-efficiency of this screening approach.\n\nTill now, there are no approved drug treatments for paediatric MASLD, and lifestyle interventions (such as restricting energy intake and increasing physical activity) are the main therapeutic strategies. However, existing studies face limitations, such as small sample sizes, diverse intervention methods, lack of standardization, and short intervention durations, which hinder their clinical application. Therefore, it is essential to explore effective health lifestyle intervention models tailored to children.\n\nThis study aims to: First, optimizing the screening and treatment pathway, assess the cost-effectiveness and applicability of WHtR as a screening tool, and develop a tiered screening system suitable for Chinese children; Second, integrating school, clinic, family, and community resources to establish a multifacted lifestyle intervention model and evaluate its efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* parents agree and support their children's weight loss, and students and parents have informed consent;\n* students in two to four grade aged 7 and 11 years old;\n* students with WHtR \\> 0.48.\n\nExclusion Criteria:\n\n* medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, virus hepatitis or nephritis;\n* obesity caused by endocrine diseases or side effects of drugs;\n* abnormal physical development like dwarfism or gigantism;\n* physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg;\n* inability to participate in school sport activities;\n* a loss in weight by vomiting or taking drugs during the past 3 months."}, 'identificationModule': {'nctId': 'NCT06905795', 'briefTitle': 'Screening and Intervention of MASLD in Children', 'organization': {'class': 'OTHER', 'fullName': 'Ningbo No. 1 Hospital'}, 'officialTitle': 'Construction and Application of Full-cycle Screening and Mangement Techniques for MASLD in Children and Adolescents', 'orgStudyIdInfo': {'id': '2024S023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comprehensive Intervention group', 'description': 'Students in the comprehensive intervention group will receive the interventions including regular screening, nutrition guidance and increase physical activity lasting one year.', 'interventionNames': ['Diagnostic Test: Fibroscan test', 'Behavioral: Nutrition guidance', 'Behavioral: Increase physical activity', 'Other: Health education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monitoring Intervention group', 'description': 'Students in the monitoring intervention group will receive regular sceeing every six months.', 'interventionNames': ['Diagnostic Test: Fibroscan test']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No Intervention.'}], 'interventions': [{'name': 'Fibroscan test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Perform Fibroscan testing on the study subjects every six months.', 'armGroupLabels': ['Comprehensive Intervention group', 'Monitoring Intervention group']}, {'name': 'Nutrition guidance', 'type': 'BEHAVIORAL', 'description': 'Each family will be matched with a nutritionist, who will provide daily online dietary guidance for parents and students during the first 21 days, followed by weekly sessions thereafter.', 'armGroupLabels': ['Comprehensive Intervention group']}, {'name': 'Increase physical activity', 'type': 'BEHAVIORAL', 'description': 'Increase physical activity time in and out of school by professional sports trainer.', 'armGroupLabels': ['Comprehensive Intervention group']}, {'name': 'Health education', 'type': 'OTHER', 'description': 'Knowledge of healthy lifestyle will be delivered in various forms such as health lectures, brochures, posters, etc.', 'armGroupLabels': ['Comprehensive Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315010', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Li Li', 'role': 'CONTACT', 'email': 'lilyningbo@163.com'}], 'facility': 'The First Affiliated Hospital of Ningbo University', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'centralContacts': [{'name': 'Li Li, MD', 'role': 'CONTACT', 'email': 'lilyningbo@163.com', 'phone': '+86 13757426626'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo No. 1 Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}