Screening and Intervention of MASLD in Children

NCT06905795 | Active Not Recruiting DMC

• 1 other identifier: 2024S023
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Children

Keywords

Children; MASLD; Lifestyle intervention; Screening

Outcome Measures

Primary Outcomes (1)

• Change in Waist-to-Height Ratio

  From enrollment to the end of treatment at 12 months and follow-up at 24 months

Secondary Outcomes (9)

• Change in Controlled Attenuation Parameters

  From enrollment to the end of treatment at 12 months and follow-up at 24 months

• Change in Liver Stiffness Measurement

  From enrollment to the end of treatment at 12 months and follow-up at 24 months

• Change in Blood Lipids

  From enrollment to the end of treatment at 12 months

• 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

Study Arms (3)

Comprehensive Intervention group

EXPERIMENTAL

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

Monitoring Intervention group

ACTIVE COMPARATOR

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

Diagnostic Test: Fibroscan test

Control group

NO INTERVENTION

No Intervention.

Interventions

Fibroscan test DIAGNOSTIC_TEST

Perform Fibroscan testing on the study subjects every six months.

Comprehensive Intervention group; Monitoring Intervention group

Nutrition guidance BEHAVIORAL

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.

Comprehensive Intervention group

Increase physical activity BEHAVIORAL

Increase physical activity time in and out of school by professional sports trainer.

Comprehensive Intervention group

Health education OTHER

Knowledge of healthy lifestyle will be delivered in various forms such as health lectures, brochures, posters, etc.

Comprehensive Intervention group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead
• Peking University: collaborator

Study Sites (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: April 1, 2025
• Study Start: April 1, 2025
• Primary Completion: May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

CN (1)