The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
NCT Number: NCT06905795
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.
This study is active but is not currently recruiting participants.
Notify Me7 year–11 year
All sexes
Interventional
Not applicable
Ningbo, Zhejiang, 315010, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
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
Liver Stiffness Measurement will be detected by Fibroscan HANDY
Time frame: From enrollment to the end of treatment at 12 months
Include TC, TG, LDL-C, and HDL-C
Time frame: From enrollment to the end of treatment at 12 months
Time frame: From enrollment to the end of treatment at 12 months
Time frame: From enrollment to the end of treatment at 12 months
Inlude ALT, AST, and GGT
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Cardiorespiratory Endurance will be assessed by 20 meter shuttle run test
Ningbo No. 1 Hospital
Other
Construction and Application of Full-cycle Screening and Mangement Techniques for MASLD in Children and Adolescents
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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