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NCT Number: NCT06905795

Screening and Intervention of MASLD in Children

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibroscan test

Diagnostic Test

Perform Fibroscan testing on the study subjects every six months.

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.

Increase Physical Activity

Behavioral

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

Health education

Other

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

Primary outcomes

  1. Change in Waist-to-Height Ratio

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

Secondary outcomes

  1. 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

  2. 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

  3. Change in Blood Lipids

    Time frame: From enrollment to the end of treatment at 12 months

    Include TC, TG, LDL-C, and HDL-C

  4. Change in Fasting Blood-Glucose

    Time frame: From enrollment to the end of treatment at 12 months

  5. Change in Fasting Insulin

    Time frame: From enrollment to the end of treatment at 12 months

  6. Change in Liver Enzyme

    Time frame: From enrollment to the end of treatment at 12 months

    Inlude ALT, AST, and GGT

  7. Change in BMI

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

  8. Change in BMI Z score

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

  9. 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

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Collaborators

  • Peking University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 1, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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