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

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Pediatric Non-alcoholic Fatty Liver Disease

Treatments: Behavioral: Lifestyle management

Study type: Observational

Funder types: Other

Identifiers

NCT05309863

BC-05660

Details and patient eligibility

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.

Enrollment: 850 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

850 participants in 2 patient groups

Residential treatment

Description:

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.

Treatment:

Behavioral: Lifestyle management

Ambulatory treatment

Description:

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.

Treatment:

Behavioral: Lifestyle management