Recruiting

Household Food Insecurity

Sponsor:

UCLA

Code:

NCT07090083

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Food Insecurity

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Food Insecurity

Study ID

NCT07090083

Start date

Jul 30, 2025

Status verified date

Aug, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

Food secure

Children with MASLD with exposure to household food security

Food insecure

Children with MASLD with exposure to household food insecurity

Primary outcome measure

  • Alanine aminotransferase (ALT) [ Time Frame: 30 days ]
  • Gamma-glutamyl transferase (GGT) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Sarah L Maxwell, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Keywords

  • MASLD
  • food insecurity
  • pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-09-02.