Fruit and vegetable vouchers to help children with MASLD and household food insecurity
Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
This program will try giving fruit and vegetable vouchers to families to see if children with MASLD who face food insecurity eat more produce and have better liver-related health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07091539 on ClinicalTrials.gov |
What this trial studies
This is a 6-month, clinic-based, one-arm pilot in which families of children with MASLD and household food insecurity receive fruit and vegetable vouchers through the EatSF Vouchers4Veggies program. Participants are children aged 6–17 with elevated BMI and elevated ALT or imaging-confirmed steatosis who receive care at UCSF liver or WATCH clinics and live in California. Outcomes include voucher redemption rates, changes in child dietary intake, clinical biomarkers (such as ALT), and qualitative interviews with caregivers about barriers and facilitators to voucher use and dietary recommendations. Data will be collected at baseline and at the end of the 6-month intervention to compare pre- and post-intervention measures.
Who should consider this trial
Good fit: Ideal candidates are children 6 to under 18 years old with MASLD (elevated BMI and elevated ALT or imaging-confirmed steatosis), who live in California, experience household food insecurity, have a parent/guardian who speaks English or Spanish, and are not already receiving EatSF vouchers or other external dietary programs.
Not a fit: Children whose liver disease is due to other known causes, who have medical conditions or medications driving weight gain, who are not food-insecure, or who live outside California or plan to move soon are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the voucher program could increase fruit and vegetable intake and lead to improved liver-related measures and better adherence to dietary recommendations for food-insecure children with MASLD.
How similar studies have performed: Observational adult studies have linked household food insecurity to MASLD and fibrosis, and voucher programs have increased produce intake in other populations, but using vouchers specifically to improve pediatric MASLD outcomes is novel and untested at scale.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Sarah L Maxwell, MD — University of California, San Francisco
- Study coordinator: Milagro Escobar
- Email: milagro.escobar@ucsf.edu
- Phone: 4155197863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.