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

NCT ID: NCT05309863

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 850 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2031-12-31

Brief Summary

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

Pediatric Non-alcoholic Fatty Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Residential treatment

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.

Lifestyle management

Intervention Type: BEHAVIORAL

Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support.

Ambulatory treatment

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.

Lifestyle management

Intervention Type: BEHAVIORAL

Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support.

Interventions

Lifestyle management

Increasing the level of physical activity, dietary intervention, acquiring healthy eating habits, and psychological support.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruth De Bruyne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

AZ Jan Palfijn

Ghent, East-Flanders, Belgium

Site Status: RECRUITING

University Hospital Gent

Ghent, East-Flanders, Belgium

Site Status: RECRUITING

Zeepreventorium

De Haan, West-Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Ruth De Bruyne, MD, PhD

Role: CONTACT

ruth.debruyne@uzgent.be

003293322966

Facility Contacts

Nele Baeck, MD

Role: primary

Ruth De Bruyne, MD, PhD

Role: primary

ruth.debruyne@uzgent.be

003293323966

Sander Lefere, MD, PhD

Role: backup

sander.lefere@ugent.be

Ellen Dupont, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 34871812 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18563842 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32623006 (View on PubMed)

Other Identifiers

BC-05660

Identifier Type: -

Identifier Source: org_study_id