Screening and Intervention of MASLD in Children

Ningbo No. 1 Hospital

Status: Active, not recruiting

Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Children

Treatments: Behavioral: Nutrition guidance; Behavioral: Increase physical activity; Other: Health education; Diagnostic Test: Fibroscan test

Study type: Interventional

Funder types: Other

Identifiers

NCT06905795

2024S023

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 7 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 3 patient groups

Comprehensive Intervention group

Experimental group

Description:

Students in the comprehensive intervention group will receive the interventions including regular screening, nutrition guidance and increase physical activity lasting one year.

Treatment:

Diagnostic Test: Fibroscan test

Other: Health education

Behavioral: Increase physical activity

Behavioral: Nutrition guidance

Monitoring Intervention group

Active Comparator group

Description:

Students in the monitoring intervention group will receive regular sceeing every six months.

Treatment:

Diagnostic Test: Fibroscan test

Control group

No Intervention group

Description:

No Intervention.