MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT06905795
Screening and Intervention of MASLD in Children
A study testing Fibroscan test, Nutrition guidance and Increase physical activity in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Children, run by Ningbo No. 1 Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Children
- What is being tested?
- Fibroscan test, Nutrition guidance and Increase physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
About this study
Official title: 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.
Read more
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.
- Being tested
- Fibroscan test, Nutrition guidance, Increase physical activity, Health education
- Keywords
- Children, MASLD, Lifestyle intervention, Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroscan testDiagnostic test
Perform Fibroscan testing on the study subjects every six months.
Nutrition guidanceBehavioural
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 activityBehavioural
Increase physical activity time in and out of school by professional sports trainer.
Health educationOther
Knowledge of healthy lifestyle will be delivered in various forms such as health lectures, brochures, posters, etc.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Fibroscan test |
| Control group | No intervention | No Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Waist-to-Height Ratio
Measured: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Secondary outcomes (9)
Change in Controlled Attenuation Parameters
Controlled Attenuation Parameters will be detected by Fibroscan HANDY
Measured: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Liver Stiffness Measurement
Liver Stiffness Measurement will be detected by Fibroscan HANDY
Measured: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Blood Lipids
Include TC, TG, LDL-C, and HDL-C
Measured: From enrollment to the end of treatment at 12 months
Change in Fasting Blood-Glucose
Measured: From enrollment to the end of treatment at 12 months
Change in Fasting Insulin
Measured: From enrollment to the end of treatment at 12 months
Change in Liver Enzyme
Inlude ALT, AST, and GGT
Measured: From enrollment to the end of treatment at 12 months
Change in BMI
Measured: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in BMI Z score
Measured: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Change in Cardiorespiratory Endurance
Cardiorespiratory Endurance will be assessed by 20 meter shuttle run test
Measured: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905795
- Sponsor's protocol ID
- 2024S023
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of Full-cycle Screening and Mangement Techniques for MASLD in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06905795
- Acronym / sponsor ID
- 2024S023
- Keywords
- Children, MASLD, Lifestyle intervention, Screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Intervention group | Experimental | Diagnostic Test: Fibroscan test, Behavioral: Nutrition guidance, Behavioral: Increase physical activity, Other: Health educationStudents in the comprehensive intervention group will receive the interventions including regular screening, nutrition guidance and increase physical activity lasting one year. |
| Monitoring Intervention group | Active comparator | Diagnostic Test: Fibroscan testStudents in the monitoring intervention group will receive regular sceeing every six months. |
| Control group | No intervention | –No Intervention. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibroscan testPerform Fibroscan testing on the study subjects every six months. | Diagnostic test | Comprehensive Intervention group, Monitoring Intervention group |
| Nutrition guidanceEach 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. | Behavioural | Comprehensive Intervention group |
| Increase physical activityIncrease physical activity time in and out of school by professional sports trainer. | Behavioural | Comprehensive Intervention group |
| Health educationKnowledge of healthy lifestyle will be delivered in various forms such as health lectures, brochures, posters, etc. | Other | Comprehensive Intervention group |
Primary outcome
Change in Waist-to-Height Ratio
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
9 secondary outcomes
Change in Controlled Attenuation Parameters
Time frame: 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
Change in Blood Lipids
Time frame: 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
Change in Fasting Insulin
Time frame: 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
Change in BMI
Time frame: 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
Change in Cardiorespiratory Endurance
Time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
Related trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
RecruitingObservational study
Clinical Profile of Patients With MASLD in Kazakhstan and Clinical Effectiveness of Ursosan in Almaty
Metabolic Dysfunction-Associated Steatotic Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroscan test, Nutrition guidance and Increase physical activity in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Children, run by Ningbo No. 1 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Waist-to-Height Ratio (time frame: From enrollment to the end of treatment at 12 months and follow-up at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.