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

NCT05309863 | Recruiting

• 1 other identifier: BC-05660
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 3

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

Keywords

NAFLD; Liver fibrosis; Lifestyle management; Multidisciplinary treatment

Outcome Measures

Primary Outcomes (1)

• Improvement of liver fibrosis

  Liver fibrosis will be quantified using Fibroscan, and patients will be divided into disease stages based on published cut-offs.

  6 months of lifestyle intervention

Secondary Outcomes (9)

• Improvement of liver fibrosis

  12 months of lifestyle intervention

• Improvement of liver steatosis

  6 months of lifestyle intervention

• Improvement of liver steatosis

  12 months of lifestyle intervention

• Resolution of liver steatosis

  6 months of lifestyle intervention

• Resolution of liver steatosis

  12 months of lifestyle intervention

Study Arms (2)

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.

Behavioral: Lifestyle management

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.

Behavioral: Lifestyle management

Interventions

Lifestyle management BEHAVIORAL

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

Ambulatory treatment; Residential treatment

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with obesity (BMI higher than the 95th weight percentile)

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)

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (3)

AZ Jan Palfijn

Ghent, East-Flanders, 9000, Belgium

RECRUITING

University Hospital Gent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Zeepreventorium

De Haan, West-Flanders, 8420, Belgium

RECRUITING

Related Publications (3)

• 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.

  PMID: 34871812 BACKGROUND

• 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.

  PMID: 18563842 BACKGROUND

• 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.

  PMID: 32623006 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruth De Bruyne, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth De Bruyne, MD, PhD

CONTACT

003293322966; ruth.debruyne@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

BE (3)