Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease
Recruiting now
Conditions studied: Pediatric Non-alcoholic Fatty Liver Disease
In brief
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.
Key facts
- Study ID
- NCT05309863
- Run by
- University Hospital, Ghent
- People needed
- 850
- Starts
- 2022-05-01
- Expected to finish
- 2031-12-31
- Last updated by the study team
- 2024-06-04
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Enrolled in the lifestyle management program for obesity in one of the participating centres
You may not qualify if…
- 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)
Where it is running
- AZ Jan Palfijn — Ghent, East-Flanders, Belgium (enrolling)
- University Hospital Gent — Ghent, East-Flanders, Belgium (enrolling)
- Zeepreventorium — De Haan, West-Flanders, Belgium (enrolling)
Full record on ClinicalTrials.gov
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