Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity

NCT07090083 | Recruiting

• 1 other identifier: 23-40614
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Food Insecurity

Keywords

MASLD; food insecurity; pediatric

Outcome Measures

Primary Outcomes (2)

• Alanine aminotransferase (ALT)

  Alanine aminotransferase (ALT)

  30 days

• Gamma-glutamyl transferase (GGT)

  Gamma-glutamyl transferase (GGT)

  30 days

Secondary Outcomes (2)

• Dietary intake of fruits and vegetables

  30 days

• dietary intake of SSBs

  30 days

Study Arms (2)

Food secure

Children with MASLD with exposure to household food security

Food insecure

Children with MASLD with exposure to household food insecurity

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with MASLD with and without exposure to household food insecurity.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Gastroenterological Association Foundation: collaborator
• UCSF Population Health Health Equity Award: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (6)

• Golovaty I, Tien PC, Price JC, Sheira L, Seligman H, Weiser SD. Food Insecurity May Be an Independent Risk Factor Associated with Nonalcoholic Fatty Liver Disease among Low-Income Adults in the United States. J Nutr. 2020 Jan 1;150(1):91-98. doi: 10.1093/jn/nxz212.

  PMID: 31504710 BACKGROUND

• Tamargo JA, Sherman KE, Campa A, Martinez SS, Li T, Hernandez J, Teeman C, Mandler RN, Chen J, Ehman RL, Baum MK. Food insecurity is associated with magnetic resonance-determined nonalcoholic fatty liver and liver fibrosis in low-income, middle-aged adults with and without HIV. Am J Clin Nutr. 2021 Mar 11;113(3):593-601. doi: 10.1093/ajcn/nqaa362.

  PMID: 33515016 BACKGROUND

• Kardashian A, Dodge JL, Terrault NA. Food Insecurity is Associated With Mortality Among U.S. Adults With Nonalcoholic Fatty Liver Disease and Advanced Fibrosis. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2790-2799.e4. doi: 10.1016/j.cgh.2021.11.029. Epub 2021 Dec 16.

  PMID: 34958747 BACKGROUND

• Kardashian A, Dodge JL, Terrault NA. Racial and ethnic differences in diet quality and food insecurity among adults with fatty liver and significant fibrosis: a U.S. population-based study. Aliment Pharmacol Ther. 2022 Nov;56(9):1383-1393. doi: 10.1111/apt.17219. Epub 2022 Sep 29.

  PMID: 36173037 BACKGROUND

• Landry MJ, van den Berg AE, Asigbee FM, Vandyousefi S, Ghaddar R, Davis JN. Child-Report of Food Insecurity Is Associated with Diet Quality in Children. Nutrients. 2019 Jul 12;11(7):1574. doi: 10.3390/nu11071574.

  PMID: 31336880 BACKGROUND

• Maxwell SL, Price JC, Perito ER, Rosenthal P, Wojcicki JM. Food insecurity is a risk factor for metabolic dysfunction-associated steatotic liver disease in Latinx children. Pediatr Obes. 2024 Jun;19(6):e13109. doi: 10.1111/ijpo.13109. Epub 2024 Mar 7.

  PMID: 38453472 BACKGROUND

Study Officials

• Sarah L Maxwell, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milagro Escobar

CONTACT

415-519-7863; milagro.escobar@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)