Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT07091539

Run by

University of California, San Francisco

People needed

48

Starts

2025-07-30

Expected to finish

2027-08-01

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…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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