NCT07090083 · University of California, San Francisco
Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- San Francisco, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 2, 2025 · Source of record for eligibility and locations