Children, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Conditions
Keywords
Children, MASLD, Lifestyle intervention, Screening
Brief 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.
Interventions
DIAGNOSTIC_TESTFibroscan test
Perform Fibroscan testing on the study subjects every six months.
BEHAVIORALNutrition 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.
BEHAVIORALIncrease physical activity
Increase physical activity time in and out of school by professional sports trainer.
OTHERHealth education
Knowledge of healthy lifestyle will be delivered in various forms such as health lectures, brochures, posters, etc.
Sponsors
Peking University
Ningbo No. 1 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* parents agree and support their children's weight loss, and students and parents have informed consent; * students in two to four grade aged 7 and 11 years old; * students with WHtR ≥ 0.48.
Exclusion criteria
* medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, virus hepatitis or nephritis; * obesity caused by endocrine diseases or side effects of drugs; * abnormal physical development like dwarfism or gigantism; * physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg; * inability to participate in school sport activities; * a loss in weight by vomiting or taking drugs during the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Waist-to-Height Ratio | From enrollment to the end of treatment at 12 months and follow-up at 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Stiffness Measurement | 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 |
| Change in Blood Lipids | From enrollment to the end of treatment at 12 months | Include TC, TG, LDL-C, and HDL-C |
| Change in Fasting Blood-Glucose | From enrollment to the end of treatment at 12 months | — |
| Change in Fasting Insulin | From enrollment to the end of treatment at 12 months | — |
| Change in Controlled Attenuation Parameters | 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 |
| Change in BMI | From enrollment to the end of treatment at 12 months and follow-up at 24 months | — |
| Change in BMI Z score | From enrollment to the end of treatment at 12 months and follow-up at 24 months | — |
| Change in Cardiorespiratory Endurance | 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 |
| Change in Liver Enzyme | From enrollment to the end of treatment at 12 months | Inlude ALT, AST, and GGT |
Countries
China
Outcome results
None listed