Screening and Intervention of MASLD in Children

January 9, 2026 updated by: Ningbo No. 1 Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • The First Affiliated Hospital of Ningbo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive Intervention group
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
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.
Active Comparator: Monitoring Intervention group
Students in the monitoring intervention group will receive regular sceeing every six months.
Diagnostic test: Fibroscan test
Perform Fibroscan testing on the study subjects every six months.
No Intervention: Control group
No Intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Waist-to-Height Ratio
Time Frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
From enrollment to the end of treatment at 12 months and follow-up at 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Controlled Attenuation Parameters
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
From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Liver Stiffness Measurement
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
From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Blood Lipids
Time Frame: From enrollment to the end of treatment at 12 months
Include TC, TG, LDL-C, and HDL-C
From enrollment to the end of treatment at 12 months
Change in Fasting Blood-Glucose
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months
Change in Fasting Insulin
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months
Change in Liver Enzyme
Time Frame: From enrollment to the end of treatment at 12 months
Inlude ALT, AST, and GGT
From enrollment to the end of treatment at 12 months
Change in BMI
Time Frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in BMI Z score
Time Frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Cardiorespiratory Endurance
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
From enrollment to the end of treatment at 12 months and follow-up at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo No. 1 Hospital

Collaborators

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024S023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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