Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle management.
- Who it may be relevant to
- Registry conditions: Pediatric Non-alcoholic Fatty Liver Disease. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Lifestyle management
Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support.
Primary outcome measures
- Improvement of liver fibrosis [Time frame: 6 months of lifestyle intervention]
Secondary outcome measures (9)
- Improvement of liver fibrosis [Time frame: 12 months of lifestyle intervention]
- Improvement of liver steatosis [Time frame: 6 months of lifestyle intervention]
- Improvement of liver steatosis [Time frame: 12 months of lifestyle intervention]
- Resolution of liver steatosis [Time frame: 6 months of lifestyle intervention]
- Resolution of liver steatosis [Time frame: 12 months of lifestyle intervention]
- Resolution of liver fibrosis [Time frame: 6 months of lifestyle intervention]
- Resolution of liver fibrosis [Time frame: 12 months of lifestyle intervention]
- Improvement in ALT [Time frame: 6 months of lifestyle intervention]
- Improvement in ALT [Time frame: 12 months of lifestyle intervention]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 3 centers
- AZ Jan Palfijn — Ghent
- University Hospital Gent — Ghent
- Zeepreventorium — De Haan
Publications
- Lefere S, Dupont E, De Guchtenaere A, Van Biervliet S, Vande Velde S, Verhelst X, Devisscher L, Van Vlierberghe H, Geerts A, De Bruyne R. Intensive Lifestyle Management Improves Steatosis and Fibrosis in Pediatric Nonalcoholic Fatty Liver Disease. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2317-2326.e4. doi: 10.1016/j.cgh.2021.11.039. Epub 2021 Dec 4. PMID 34871812
- Nobili V, Vizzutti F, Arena U, Abraldes JG, Marra F, Pietrobattista A, Fruhwirth R, Marcellini M, Pinzani M. Accuracy and reproducibility of transient elastography for the diagnosis of fibrosis in pediatric nonalcoholic steatohepatitis. Hepatology. 2008 Aug;48(2):442-8. doi: 10.1002/hep.22376. PMID 18563842
- Ciardullo S, Monti T, Perseghin G. Prevalence of Liver Steatosis and Fibrosis Detected by Transient Elastography in Adolescents in the 2017-2018 National Health and Nutrition Examination Survey. Clin Gastroenterol Hepatol. 2021 Feb;19(2):384-390.e1. doi: 10.1016/j.cgh.2020.06.048. Epub 2020 Jul 3. PMID 32623006
Identifiers
NCT: NCT05309863 · BC-05660