Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07091539
Status
Recruiting
Apply to this trial

Conditions

  • Food Insecurity Among Children
  • MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jul 30, 2025
Status verified
Aug 2025
Primary completion
Jul 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

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

Primary Outcome Measure

Voucher participation [ Time Frame: From enrollment to the end of the six month intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158-

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CA

Related Studies