Actively Recruiting
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
Eligibility Criteria
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.
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
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
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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