NCT06905795

Screening and Intervention of MASLD in Children

Construction and Application of Full-cycle Screening and Mangement Techniques for MASLD in Children and Adolescents

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Ningbo No. 1 Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
• Children

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fibroscan test	Perform Fibroscan testing on the study subjects every six months.
BEHAVIORAL	Nutrition guidance	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.
BEHAVIORAL	Increase physical activity	Increase physical activity time in and out of school by professional sports trainer.
OTHER	Health education	Knowledge of healthy lifestyle will be delivered in various forms such as health lectures, brochures, posters, etc.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2025-04-01
• Last updated: 2026-01-12

Locations

1 site across 1 country: China