NCT07091539Recruiting
Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- University of California, San Francisco
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07091539
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 30 Jul 2025 to the primary completion date, 30 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- child is on a weight loss medication (including: Qsymia or GLP-1 receptor agonists),
Other illness
- 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;
Other
- both of which are assessed as part of routine clinical care.
Who the study is looking for
- The study population for all study aims consists of children and adolescents receiving care at the liver and WATCH clinics.
- 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
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.