RECRUITING

Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pediatric MASLD and Food Insecurity

Quick Facts

Study Start:2025-07-30
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07090083

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children and adolescents receiving care in the liver and WATCH clinics.
  2. * Family living in California.
  3. * Parent/guardian speaks Spanish or English.
  4. * Child is between the ages of 6 to \<17 years.
  5. * Elevated ALT on at least 2 occasions within the past year:
  6. * ALT \> 22 units/L for females.
  7. * ALT \> 26 units/L for males.
  8. * BMI for age/sex ≥ 85%.
  9. * Alternatively, child has one elevated ALT within the past year and confirmed steatosis on imaging.
  10. * Family does not intend to move out of California within the next year.
  11. * Family is not already receiving EatSF SF Fruit and Vegetable Vouchers.
  12. * Family is not participating in any other dietary education programs besides those offered by the WATCH or liver clinics.
  1. * Child has an underlying condition or medication causing their weight gain (e.g., hypothyroidism, Prader-Willi syndrome, antipsychotic medications).
  2. * Child is on, or expected to go on, or starts on a weight loss medication (e.g., Qsymia or GLP-1 receptor agonists).
  3. * Child has another known cause of liver disease (not including MASLD or MASH), such as:
  4. * Autoimmune hepatitis.
  5. * Wilson's disease.
  6. * Hepatitis A, B, or C.
  7. * Acute infection.
  8. * Genetic condition causing inflammation in the liver.

Contacts and Locations

Study Contact

Milagro Escobar
CONTACT
415-519-7863
milagro.escobar@ucsf.edu

Principal Investigator

Sarah L Maxwell, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94158
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Sarah L Maxwell, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2025-07-30
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • MASLD
  • food insecurity
  • pediatric

Additional Relevant MeSH Terms

  • MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Food Insecurity