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临床试验/NCT06905795
NCT06905795进行中(未招募)不适用

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

Ningbo No. 1 Hospital2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
270
试验地点
2
主要终点
Change in Waist-to-Height Ratio

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Fibroscan test (Diagnostic Test)

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.

干预措施: Nutrition guidance (Behavioral)

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.

干预措施: Increase physical activity (Behavioral)

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.

干预措施: Health education (Other)

Monitoring Intervention group

Active Comparator

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

干预措施: Fibroscan test (Diagnostic Test)

Control group

No Intervention

No Intervention.

结局指标

主要结局

Change in Waist-to-Height Ratio

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

次要结局

  • Change in BMI Z score(From enrollment to the end of treatment at 12 months and follow-up at 24 months)
  • 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)
  • Change in Liver Enzyme(From enrollment to the end of treatment at 12 months)
  • Change in BMI(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)

研究者

发起方
Ningbo No. 1 Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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