Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent chronic liver disease worldwide, paralleling the obesity pandemic. Secondary to increasing rates of obesity in children and adolescents, the prevalence of NAFLD has more than doubled in the last decades and is now the most common pediatric liver disease. At present, lifestyle modification by dietary intervention and increasing physical activity is the mainstay of treatment for pediatric NAFLD. Several studies have shown that lifestyle intervention and weight loss improve non-invasive markers of NAFLD. To the investigator's knowledge, data on fibrosis regression following lifestyle treatment in children and adolescents were lacking. The investigators therefore performed a prospective cohort study to investigate the impact of residential lifestyle treatment on liver steatosis and fibrosis in obese children and adolescents. As a follow-up, the investigators now aim to compare these findings with a cohort of well-characterized patients undergoing multidisciplinary, yet ambulatory, weight loss treatment. As such, the investigators will compare the outcomes in two prospective patient cohorts in this non-randomized observational study.

Official Title
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Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease

Conditions
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Pediatric Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Behavioral: Lifestyle management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in the lifestyle management program for obesity in one of the participating centres Exclusion Criteria: Syndromic obesity Evidence of liver disease of other causes (viral, auto-immune, genetic) Average daily alcohol consumption of >20g/day Unvalid screening Fibroscan Treatment with drugs which can induce liver steatosis or fibrosis (e.g. systemic corticosteroids, methotrexate)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Residential treatment<br>Patients administered for residential treatment of severe obesity will be included. Patients are treated according to standard of care in a multimodal program, focusing on increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support. Residential treatment is possible for a duration of maximum 1 year. | Behavioral: Lifestyle management<br>* Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support.<br>|
| Ambulatory treatment<br>Patients in specific pediatric obesity care pathways will be included. Patients are treated according to standard of care in a multimodal ambulatory program focusing on increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support. | Behavioral: Lifestyle management<br>* Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of liver fibrosis | Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs. | 6 months of lifestyle intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of liver fibrosis | Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs. | 12 months of lifestyle intervention | 
| Improvement of liver steatosis | Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan | 6 months of lifestyle intervention | 
| Improvement of liver steatosis | Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan | 12 months of lifestyle intervention | 
| Resolution of liver steatosis | Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan. Resolution of steatosis is identified as CAP <248 dB/m at follow-up in patients with baseline CAP of 248 dB/m or higher. | 6 months of lifestyle intervention | 
| Resolution of liver steatosis | Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan. Resolution of steatosis is identified as CAP <248 dB/m at follow-up in patients with baseline CAP of 248 dB/m or higher. | 12 months of lifestyle intervention | 
| Resolution of liver fibrosis | Liver fibrosis will be quantified using Fibroscan. Resolution of fibrosis is identified as liver stiffness <7.0 kPa at follow-up in patients with baseline liver stiffness of 7.0 kPa or higher. | 6 months of lifestyle intervention | 
| Resolution of liver fibrosis | Liver fibrosis will be quantified using Fibroscan. Resolution of fibrosis is identified as liver stiffness <7.0 kPa at follow-up in patients with baseline liver stiffness of 7.0 kPa or higher. | 12 months of lifestyle intervention | 
| Improvement in ALT | Proportion of patients with at least 30% decrease in serum ALT levels at follow-up, out of the patients with baseline elevated ALT | 6 months of lifestyle intervention | 
| Improvement in ALT | Proportion of patients with at least 30% decrease in serum ALT levels at follow-up, out of the patients with baseline elevated ALT | 12 months of lifestyle intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, Liver fibrosis, Lifestyle management, Multidisciplinary treatment