Comparing weight loss programs for children with fatty liver disease
Official title: Comparison Between the Efficacy of Residential and Ambulatory Weight Loss Programs for Pediatric Non-alcoholic Fatty Liver Disease
Run by University Hospital, Ghent · NCT05309863 · Data updated 2026-11-12
This study is trying to see if kids with fatty liver disease do better with weight loss programs at home or in a residential setting.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 8 Years to 18 Years |
| Sex | All |
| Enrollment | 850 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 3 sites (Ghent, East-Flanders and 2 other locations) |
| Status | Recruiting |
| Started | May 1, 2022 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2031 |
| Registry record updated | June 4, 2024 |
| Trial ID | NCT05309863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are obese children and adolescents enrolled in a lifestyle management program for obesity.
✕Probably not a fit
Patients with syndromic obesity or other causes of liver disease, as well as those consuming significant amounts of alcohol, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of residential versus ambulatory weight loss programs in treating pediatric non-alcoholic fatty liver disease (NAFLD). It focuses on lifestyle modifications, including dietary changes and increased physical activity, as the primary treatment for this condition. The study aims to assess the impact of these interventions on liver health, specifically looking at liver steatosis and fibrosis in obese children and adolescents. By comparing outcomes from different treatment settings, the research seeks to provide insights into the most effective approaches for managing NAFLD in this population.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for children with fatty liver disease, enhancing their liver health and overall well-being.
How similar studies have gone: Previous studies have shown that lifestyle interventions can improve markers of NAFLD, suggesting that this approach may be effective, although the specific comparison of residential versus ambulatory programs is less explored.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
AZ Jan Palfijn
Ghent, East-Flanders, Belgium Recruiting -
University Hospital Gent
Ghent, East-Flanders, Belgium Recruiting -
Zeepreventorium
De Haan, West-Flanders, Belgium Recruiting
Study contacts
- Principal investigator: Ruth De Bruyne, MD, PhD — University Hospital, Ghent
- Study coordinator: Ruth De Bruyne, MD, PhD
- Email: ruth.debruyne@uzgent.be
- Phone: 003293322966
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.