Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
270 participants
INTERVENTIONAL
2025-04-01
2027-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
Fibroscan test
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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.
Increase physical activity
Increase physical activity time in and out of school by professional sports trainer.
Health education
Knowledge of healthy lifestyle will be delivered in various forms such as health lectures, brochures, posters, etc.
Monitoring Intervention group
Students in the monitoring intervention group will receive regular sceeing every six months.
Fibroscan test
Perform Fibroscan testing on the study subjects every six months.
Control group
No Intervention.
No interventions assigned to this group
Interventions
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Fibroscan test
Perform Fibroscan testing on the study subjects every six months.
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.
Increase physical activity
Increase physical activity time in and out of school by professional sports trainer.
Health education
Knowledge of healthy lifestyle will be delivered in various forms such as health lectures, brochures, posters, etc.
Eligibility Criteria
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Inclusion Criteria
* students in two to four grade aged 7 and 11 years old;
* students with WHtR ≥ 0.48.
Exclusion Criteria
* 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.
7 Years
11 Years
ALL
Yes
Sponsors
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Peking University
OTHER
Ningbo No. 1 Hospital
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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2024S023
Identifier Type: -
Identifier Source: org_study_id
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