Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study (NCT07091539)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California, San Francisco — San Francisco, California
Age range: 6 Years to 17 Years
🧪 Interventions in This Study
- Fruit/vegetable vouchers (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of California, San Francisco — San Francisco, California
📞 Contact the Study Coordinator
Phone: (415) 519-7863
Email: milagro.escobar@ucsf.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Screening Cardiometabolic Opportunities Using Transformative Echocardiography Artificial Intelligence (SCOUT Echo-AI) — Los Angeles, California
- Effect of Ketone Esters on Liver Fat Content and Metabolic Function — St Louis, Missouri
- Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis — Seattle, Washington
- Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity — San Francisco, California
- A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV — Birmingham, Alabama
Explore by condition: All MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.