About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Autoimmune hepatitis.
Wilson's disease.
Trial population
Children with MASLD with and without exposure to household food insecurity.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT)
Gamma-glutamyl transferase (GGT)
Gamma-glutamyl transferase (GGT)
Secondary outcomes
Dietary intake of fruits and vegetables
Dietary intake of fruit and vegetables
dietary intake of SSBs
Dietary intake of sugar sweetened beverages
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
American Gastroenterological Association Foundation
Collaborator
UCSF Population Health Health Equity Award
Collaborator