NCT07090083 Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity
| NCT ID | NCT07090083 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2025-07-30 with a primary completion date of 2026-12-30.
⚠ 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 our understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. There is evidence that children in families that do not have the ability to provide consistently healthy and high-quality foods, such as fruits and vegetables, have worse diet quality that children in households that are food secure. Additionally, evidence from adult studies link 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 4 times 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 explore the association of household FI and pediatric MASLD disease severity and whether those effects are mediated by dietary intake. Study participants include children/adolescents with MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic.
Eligibility Criteria
Inclusion Criteria: * Children and adolescents receiving care in the liver and WATCH clinics. * Family living in California. * Parent/guardian speaks Spanish or English. * Child is between the ages of 6 to \<17 years. * Elevated ALT on at least 2 occasions within the past year: * ALT \> 22 units/L for females. * ALT \> 26 units/L for males. * BMI for age/sex ≥ 85%. * Alternatively, child has one elevated ALT within the past year and confirmed steatosis on imaging. * Family does not intend to move out of California within the next year. * Family is not already receiving EatSF SF Fruit and Vegetable Vouchers. * Family is not participating in any other dietary education programs besides those offered by the WATCH or liver clinics. Exclusion Criteria: * Child has an underlying condition or medication causing their weight gain (e.g., hypothyroidism, Prader-Willi syndrome, antipsychotic medications). * Child is on, or expected to go on, or starts on a weight loss medication (e.g., Qsymia or GLP-1 receptor agonists). * Child has another known cause of liver disease (not including MASLD or MASH), such as: * Autoimmune hepatitis. * Wilson's disease. * Hepatitis A, B, or C. * Acute infection. * Genetic condition causing inflammation in the liver.
Contact & Investigator
Sarah L Maxwell, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07090083 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 NCT07090083 currently recruiting?
Yes, NCT07090083 is actively recruiting participants. Contact the research team at milagro.escobar@ucsf.edu for enrollment information.
Where is the NCT07090083 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07090083 clinical trial?
NCT07090083 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 160 participants.