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NCT Number: NCT05309863

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

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.

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Key information

Conditions

Pediatric Non-alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Fibrosis Liver Cirrhosis Liver Diseases Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Jan Palfijn, Ghent, East-Flanders, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lifestyle Management

Behavioral

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

Primary outcomes

  1. Improvement of liver fibrosis

    Time frame: 6 months of lifestyle intervention

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

Secondary outcomes

  1. Improvement of liver fibrosis

    Time frame: 12 months of lifestyle intervention

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

  2. Improvement of liver steatosis

    Time frame: 6 months of lifestyle intervention

    Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan

  3. Improvement of liver steatosis

    Time frame: 12 months of lifestyle intervention

    Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan

  4. Resolution of liver steatosis

    Time frame: 6 months of lifestyle intervention

    Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan. Resolution of steatosis is identified as CAP <248 dB/m at follow-up in patients with baseline CAP of 248 dB/m or higher.

  5. Resolution of liver steatosis

    Time frame: 12 months of lifestyle intervention

    Liver steatosis will be quantified using controlled attenuation parameter on the Fibroscan. Resolution of steatosis is identified as CAP <248 dB/m at follow-up in patients with baseline CAP of 248 dB/m or higher.

  6. Resolution of liver fibrosis

    Time frame: 6 months of lifestyle intervention

    Liver fibrosis will be quantified using Fibroscan. Resolution of fibrosis is identified as liver stiffness <7.0 kPa at follow-up in patients with baseline liver stiffness of 7.0 kPa or higher.

  7. Resolution of liver fibrosis

    Time frame: 12 months of lifestyle intervention

    Liver fibrosis will be quantified using Fibroscan. Resolution of fibrosis is identified as liver stiffness <7.0 kPa at follow-up in patients with baseline liver stiffness of 7.0 kPa or higher.

  8. Improvement in ALT

    Time frame: 6 months of lifestyle intervention

    Proportion of patients with at least 30% decrease in serum ALT levels at follow-up, out of the patients with baseline elevated ALT

  9. Improvement in ALT

    Time frame: 12 months of lifestyle intervention

    Proportion of patients with at least 30% decrease in serum ALT levels at follow-up, out of the patients with baseline elevated ALT

Study contacts

Contact information is provided by the study sponsor or research team.

Ruth De Bruyne, MD, PhD

CONTACT

[email protected]

003293322966

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2022
Primary completion
2030
Study completion
2031
First posted
Apr 4, 2022
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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