Actively Recruiting

Age: 8Years - 18Years
All Genders
NCT05309863

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

Led by University Hospital, Ghent · Updated on 2024-06-04

850

Participants Needed

3

Research Sites

504 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Enrolled in the lifestyle management program for obesity in one of the participating centres
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

AZ Jan Palfijn

Ghent, East-Flanders, Belgium, 9000

Actively Recruiting

2

University Hospital Gent

Ghent, East-Flanders, Belgium, 9000

Actively Recruiting

3

Zeepreventorium

De Haan, West-Flanders, Belgium, 8420

Actively Recruiting

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Research Team

R

Ruth De Bruyne, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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