Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity

Recruiting now

Conditions studied: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Food Insecurity

In brief

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.

Key facts

Study ID

NCT07090083

Run by

University of California, San Francisco

People needed

160

Starts

2025-07-30

Expected to finish

2026-12-30

Last updated by the study team

2025-09-02

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescents receiving care in the liver and WATCH clinics.
• Family living in California.
• Parent/guardian speaks Spanish or English.
• Child is between the ages of 6 to <17 years.
• Elevated ALT on at least 2 occasions within the past year:
• ALT > 22 units/L for females.
• ALT > 26 units/L for males.
• BMI for age/sex ≥ 85%.
• 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 any other dietary education programs besides those offered by the WATCH or liver clinics.

You may not qualify if…

• Child has an underlying condition or medication causing their weight gain (e.g., hypothyroidism, Prader-Willi syndrome, antipsychotic medications).
• Child is on, or expected to go on, or starts on a weight loss medication (e.g., Qsymia or GLP-1 receptor agonists).
• Child has another known cause of liver disease (not including MASLD or MASH), such as:
• Autoimmune hepatitis.
• Wilson's disease.
• Hepatitis A, B, or C.
• Acute infection.
• Genetic condition causing inflammation in the liver.

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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