Household food insecurity and MASLD in children and adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll children aged 6–17 who are followed in UCSF liver and WATCH clinics, have BMI ≥85th percentile, and have elevated ALT or imaging-confirmed steatosis. Researchers will collect household food insecurity measures, diet quality data, clinical labs (including ALT), and liver imaging/fibrosis markers to characterize disease severity. Families must live in California, speak English or Spanish, and not already receive specified fruit-and-vegetable voucher programs or outside dietary education. Analyses will examine associations between household food insecurity and MASLD severity while excluding children with other medical or medication causes of weight gain.

Why it matters

Who can join: the full rules

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 it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Sarah L Maxwell, MD — University of California, San Francisco
• Study coordinator: Milagro Escobar
• Email: milagro.escobar@ucsf.edu
• Phone: 415-519-7863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.