Household food insecurity and MASLD in children and adolescents

Pediatric MASLD and Food Insecurity

This research will see if household food insecurity is linked to worse MASLD in children and adolescents who have elevated ALT and are overweight or obese.

Quick facts

• Study type: Observational
• Enrollment: 160 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07090083 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children 6–17 years old in California who receive care at the UCSF liver or WATCH clinics, have BMI ≥85th percentile and elevated ALT or imaging-confirmed steatosis, and whose caregivers speak English or Spanish are the intended participants.

Not a fit: Children with MASLD driven primarily by identifiable medical or medication causes, those already receiving fruit-and-vegetable voucher programs, or families outside California are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the findings could point to food security as a modifiable social factor and support targeted food-access interventions to reduce MASLD severity in children.

How similar studies have performed: Adult studies have linked household food insecurity to MASLD and fibrosis and the PI's prior work found early-life food insecurity was associated with nearly fourfold higher odds of pediatric MASLD, but pediatric evidence is still limited.

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.

Where this trial is running

San Francisco, California

• 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

Conditions MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Food Insecurity; MASLD; food insecurity; pediatric