Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

160 Participants
are grouped into 2 trial groups
Group A: Food secure
Group B: Food insecure

Trial outcomes

Primary outcomes

1

Alanine aminotransferase (ALT)

Alanine aminotransferase (ALT)

Time frame
30 days
2

Gamma-glutamyl transferase (GGT)

Gamma-glutamyl transferase (GGT)

Time frame
30 days

Secondary outcomes

1

Dietary intake of fruits and vegetables

Dietary intake of fruit and vegetables

Time frame
30 days
2

dietary intake of SSBs

Dietary intake of sugar sweetened beverages

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

American Gastroenterological Association Foundation

Collaborator

UCSF Population Health Health Equity Award

Collaborator