NCT07091539 Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
| NCT ID | NCT07091539 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-07-30 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Sarah L Maxwell, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07091539 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07091539 currently recruiting?
Yes, NCT07091539 is actively recruiting participants. Contact the research team at milagro.escobar@ucsf.edu for enrollment information.
Where is the NCT07091539 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07091539 clinical trial?
NCT07091539 is sponsored by University of California, San Francisco. The principal investigator is Sarah L Maxwell, MD at University of California, San Francisco. The trial plans to enroll 48 participants.