Actively Recruiting
Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
Led by University of California, San Francisco · Updated on 2025-09-02
48
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
A
American Gastroenterological Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents receiving care at the UCSF liver or WATCH clinics
- Family lives in California
- Parent or guardian speaks Spanish or English
- Child is aged 6 to under 18 years
- Child has a BMI at or above the 85th percentile for age and sex
- Child has elevated ALT liver enzyme levels (greater than 26 for boys and 22 for girls) on two occasions within the last year, or one elevated ALT plus imaging confirming liver fat
- Family does not plan to move out of California for the next year
- Family is not currently receiving EatSF fruit and vegetable vouchers
- Family is not participating in other dietary education programs besides those offered by the liver or WATCH clinics
You will not qualify if you...
- Child has medical conditions or medications causing weight gain, such as hypothyroidism, Prader-Willi syndrome, or antipsychotic medications
- Child has liver diseases other than MASLD or MASH causing elevated liver enzymes
- Child is currently taking weight loss medications including Qsymia or GLP-1 receptor agonists
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
M
Milagro Escobar
CONTACT
S
Sarah L Maxwell, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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