NCT07091539

Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study designs for each of the three specific aims are below: Aim 1: Assess participation in the EatSF intervention (to be piloted in the liver and WATCH clinics) among families with a child with MASLD and household FI, as identified through an observational cross-sectional study. Design: To achieve this aim, the investigators will conduct a 6-month pre-post one-arm pilot intervention study of the EatSF Vouchers4Veggies fruit and voucher program with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics. At the end of the 6-month intervention period, the investigators will assess the percentage of vouchers redeemed through a software program developed by EatSF Vouchers4Veggies. Also at the end of the 6-month intervention, the CRC will administer study assessments comparable to those conducted at baseline as part of the observational cross-sectional study (for which IRB approval has been submitted). Also at the end of the 6-month intervention, the CRC will conduct semi-structured interviews to identify barriers and facilitators to: 1. voucher redemption, 2. adhering to clinic dietary recommendations, and 3. parental understanding of MASLD and the role of diet in its management. Aim 2: Assess changes in dietary intake in children with MASLD and FI participating in the 6-month pre-post one-arm pilot intervention study with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics (projected n=48). Design: To achieve this aim, the investigators will analyze changes in the baseline data collected as part of the observational cross-sectional study (for which IRB approval has been submitted) with post-test data (collected at the end of the six-month pilot study). Exploratory Aim 3: Assess changes in liver inflammation measured by alanine aminotransferase serum lab (ALT) (GGT), and other cardiometabolic health factors in children with MASLD and household FI from baseline to the end of the 6-month study. Design: To achieve this aim, the investigators will analyze data collected from the 6-month pre-post one-arm pilot intervention study with families with a child with household FI and MASLD who receive care at UCSF's liver and WATCH clinics.

Conditions

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

Interventions

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

Timeline

• Start date: 2025-07-30
• Primary completion: 2027-07-30
• Completion: 2027-08-01
• First posted: 2025-07-29
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States