NCT07090083Recruiting
Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity
Pediatric MASLD and Food Insecurity
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 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- University of California, San Francisco
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07090083
What you commit to
- Study type: Observational
- Planned participants: 160
- From 30 Jul 2025 to the primary completion date, 30 Dec 2026
- 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, or expected to go on, or starts on a weight loss medication (e.g., Qsymia or GLP-1 receptor agonists).
Other illness
- Child has an underlying condition or medication causing their weight gain (e.g., hypothyroidism, Prader-Willi syndrome, antipsychotic medications).
- 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.
Who the study is looking for
- 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.
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.