Actively Recruiting

Age: 6Years - 17Years
All Genders
NCT07090083

Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity

Led by University of California, San Francisco · Updated on 2025-09-02

160

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

A

American Gastroenterological Association Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This proposal addresses a critical gap in our understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. There is evidence that children in families that do not have the ability to provide consistently healthy and high-quality foods, such as fruits and vegetables, have worse diet quality that children in households that are food secure. Additionally, evidence from adult studies link household FI to MASLD and liver fibrosis, and prior research of the PI has shown that exposure to household FI in early childhood was associated with a nearly 4 times increased odds of pediatric MASLD in middle childhood. Possible mechanisms linking household FI to pediatric MASLD include lower intake of fruits and vegetables, higher intake of caloric dense nutrient poor foods (e.g., sugar sweetened beverages), and less diversity of foods. Given consensus recommendations for the management of MASLD focus on lifestyle modification, i.e., diet and exercise to achieve weight loss, this proposal seeks to explore the association of household FI and pediatric MASLD disease severity and whether those effects are mediated by dietary intake. Study participants include children/adolescents with MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic.

CONDITIONS

Official Title

Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents receiving care in the liver and WATCH clinics.
  • Family living in California.
  • Parent or guardian speaks Spanish or English.
  • Child is between 6 and under 17 years old.
  • Elevated ALT on at least 2 occasions within the past year (>22 units/L for females, >26 units/L for males).
  • BMI for age/sex at or above 85th percentile.
  • Alternatively, child has one elevated ALT within the past year and confirmed steatosis on imaging.
  • Family does not intend to move out of California within the next year.
  • Family is not already receiving EatSF SF Fruit and Vegetable Vouchers.
  • Family is not participating in other dietary education programs besides those offered by the WATCH or liver clinics.
Not Eligible

You will not qualify if you...

  • Child has an underlying condition or is on medication causing weight gain (e.g., hypothyroidism, Prader-Willi syndrome, antipsychotic medications).
  • Child is on, expected to start, or has started weight loss medication (e.g., Qsymia or GLP-1 receptor agonists).
  • Child has another known cause of liver disease besides MASLD or MASH, such as autoimmune hepatitis, Wilson's disease, hepatitis A, B, or C, acute infection, or genetic liver inflammation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

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Research Team

M

Milagro Escobar

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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