Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity

Not yet recruiting

• Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Food Insecurity

• Registration Number: NCT07090083
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Metabolic dysfunction-associated steatotic liver disease (MASLD) is now the most common type of chronic liver disease among children and adolescents in the US, with the highest burden among children from low-income families, those with obesity, and those who are Hispanic. MASLD describes a spectrum of liver injury from simple hepatic steatosis to steatohepatitis, which can progress to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver failure. MASLD is one of the leading indications for liver transplantation in adults. Emerging evidence in adults links household FI to MASLD, liver fibrosis, and mortality. FI is defined by the US Department of Agriculture (USDA) as a state in which there is "limited or uncertain availability of nutritionally adequate and safe foods or limited or uncertain ability to acquire foods in socially acceptable ways." Adults with MASLD and FI have been shown to have poor diet quality that is significantly associated with fibrosis.

Research has found that household FI is highly prevalent in families with children. Fifteen percent of U.S. households, and 30% of San Francisco households with children are food insecure, which limits the ability of these families to consistently provide healthy, high-quality food. Research has found that children living in food insecure households have worse diet quality with regard to specific food categories compared to those in food secure households. Specifically children in food insecure households consume fewer fruits and vegetables (F\&V), and more SSBs. Children in households with severe FI have worse overall diet quality than those who are food secure.

Researchers, including the PI (see preliminary studies below), have found that exposure to household FI in children/adolescents is associated with pediatric MASLD. Given current consensus recommendations for the management of pediatric MASLD focus on lifestyle interventions, i.e., diet and physical activity), this project will assess the association of household FI and MASLD disease severity and whether these effects are mediated by dietary intake.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study Start: 2025-07-23
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Study Population: The study population for all study aims consists of children and adolescents receiving care at in the liver and WATCH clinics.

Inclusion criteria include:

family living in California; parent/guardian speaks Spanish or English, child is between the ages of 6 to <17 years; Child has elevated ALT on at least 2 occasions within the past year (ALT more than 22 units /L for females and more than 26 U/L for males) and a BMI for age/ sex ≥ 85%; Or child has one elevated ALT within the past year and confirmed steatosis on imaging; Family does not intend to move out of the above for 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 that offered by the WATCH/liver clinics.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alanine aminotransferase (ALT)	30 days	Alanine aminotransferase (ALT)
Gamma-glutamyl transferase (GGT)	30 days	Gamma-glutamyl transferase (GGT)

Secondary Outcome Measures

Name	Time	Method
Dietary intake of fruits and vegetables	30 days	Dietary intake of fruit and vegetables
dietary intake of SSBs	30 days	Dietary intake of sugar sweetened beverages

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States