An interventional study of Fibroscan test and Nutrition guidance in MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Children, sponsored by Ningbo No. 1 Hospital. Active, not recruiting at 1 site in China. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Prevention
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.
Previous 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.
Till 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.
This 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.
Ningbo No. 1 Hospital is the lead sponsor of 56 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Students in the comprehensive intervention group will receive the interventions including regular screening, nutrition guidance and increase physical activity lasting one year.
Diagnostic Test: Fibroscan test · Behavioral: Nutrition guidance · Behavioral: Increase physical activity · Other: Health education
Students in the monitoring intervention group will receive regular sceeing every six months.
Diagnostic Test: Fibroscan test
No Intervention.
Perform Fibroscan testing on the study subjects every six months.
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.
Increase physical activity time in and out of school by professional sports trainer.
Knowledge of healthy lifestyle will be delivered in various forms such as health lectures, brochures, posters, etc.
Change in Waist-to-Height Ratio
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Controlled Attenuation Parameters
Controlled Attenuation Parameters will be detected by Fibroscan HANDY
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Liver Stiffness Measurement
Liver Stiffness Measurement will be detected by Fibroscan HANDY
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Blood Lipids
Include TC, TG, LDL-C, and HDL-C
Time frame: From enrollment to the end of treatment at 12 months
Change in Fasting Blood-Glucose
Time frame: From enrollment to the end of treatment at 12 months
Change in Fasting Insulin
Time frame: From enrollment to the end of treatment at 12 months
Change in Liver Enzyme
Inlude ALT, AST, and GGT
Time frame: From enrollment to the end of treatment at 12 months
Change in BMI
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in BMI Z score
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Cardiorespiratory Endurance
Cardiorespiratory Endurance will be assessed by 20 meter shuttle run test
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Ningbo No. 1 Hospital