Recruiting

EatSF

Sponsor:

UCLA

Code:

NCT07091539

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Food Insecurity Among Children

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Fruit/vegetable vouchers

Study Details

Brief summary:

This proposal addresses a critical gap in the understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. Evidence from adult studies links 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 fourfold 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 assess whether a clinic-based fruit/vegetable voucher intervention program (EatSF) could potentially improve clinical outcomes for children/adolescents with MASLD and household FI. Study participants include children/adolescents with household FI and MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic. The study seeks to identify barriers and facilitators to fruit/vegetable voucher redemption, and assess changes in dietary intake, MASLD severity, and other cardiometabolic health factors in children participating in the pilot intervention. Study findings will form the basis of an R01 application to conduct a fully powered randomized controlled trial of the intervention.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Food Insecurity Among Children

Study ID

NCT07091539

Start date

Jul 30, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The study population for all study aims consists of children and adolescents receiving care at the liver and WATCH clinics.

Inclusion criteria include:

  • family living in California;
  • a parent/guardian who speaks Spanish or English,
  • child is between the ages of 6 to <18 years;
  • child has elevated BMI greater than or equal to 85% for age and sex
  • child has ALT value greater than 26 for boys and 22 for girls on two occasions within the last year; OR one elevated ALT value and imaging confirming steatosis
  • family does not intend to move out of California for the next year;
  • family is not already receiving EatSF Fruit and Vegetable Vouchers;
  • family is not participating in any other dietary education programs besides that offered by the liver/ WATCH clinics

Exclusion Criteria:

  • child has an underlying condition or medication causing their weight gain (i.e., hypothyroidism, Prader-Willi syndrome, antipsychotic medications) or a known liver condition other than MASLD/MASH causing their elevated liver numbers;
  • child is on a weight loss medication (including: Qsymia or GLP-1 receptor agonists),
  • both of which are assessed as part of routine clinical care.

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Children with MASLD and food insecurity

This group will receive $80 of fruit/vegetable vouchers per month x 6 months; parents/ guardians will participate in a semi-structured interview at the end of the study

Interventions

Fruit/vegetable vouchers

The intervention is $80 of fruit/vegetable vouchers (EatSF Veggies4Vouchers) per month x 6 months

Primary outcome measure

  • Voucher participation [ Time Frame: From enrollment to the end of the six month intervention ]
  • Changes in dietary intake [ Time Frame: From baseline to the end of the six month intervention ]
  • changes in liver inflammation and other cardiometabolic health factors [ Time Frame: From baseline to the end of the six months study. ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Keywords

  • MASLD
  • Food insecurity
  • pediatrics

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.