Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study

NCT07091539 | Recruiting

• 1 other identifier: 24-42019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal addresses a critical gap in the understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. Evidence from adult studies links 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 fourfold 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 assess whether a clinic-based fruit/vegetable voucher intervention program (EatSF) could potentially improve clinical outcomes for children/adolescents with MASLD and household FI. Study participants include children/adolescents with household FI and MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic. The study seeks to identify barriers and facilitators to fruit/vegetable voucher redemption, and assess changes in dietary intake, MASLD severity, and other cardiometabolic health factors in children participating in the pilot intervention. Study findings will form the basis of an R01 application to conduct a fully powered randomized controlled trial of the intervention.

Conditions

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

Keywords

MASLD; Food insecurity; pediatrics

Outcome Measures

Primary Outcomes (3)

• Voucher participation

  What percentage of money of the vouchers were used monthly

  From enrollment to the end of the six month intervention

• Changes in dietary intake

  Assess changes in dietary intake in children with MASLD and FI participating in the 6 month pre-post one arm pilot intervention studies.

  From baseline to the end of the six month intervention

• changes in liver inflammation and other cardiometabolic health factors

  Assess changes in liver inflammation as measured by ALT and GGT and other cardiometabolic health factors in children with MASLD and FI from baseline to the end of the six months study.

  From baseline to the end of the six months study.

Other Outcomes (1)

• Semi-structured interviews

  At the end of the six month intervention

Study Arms (1)

Children with MASLD and food insecurity

EXPERIMENTAL

This group will receive $80 of fruit/vegetable vouchers per month x 6 months; parents/ guardians will participate in a semi-structured interview at the end of the study

Other: Fruit/vegetable vouchers

Interventions

Fruit/vegetable vouchers OTHER

The intervention is $80 of fruit/vegetable vouchers (EatSF Veggies4Vouchers) per month x 6 months

Children with MASLD and food insecurity

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The study population for all study aims consists of children and adolescents receiving care at the liver and WATCH clinics.
• family living in California;
• a parent/guardian who speaks Spanish or English,
• child is between the ages of 6 to \<18 years;
• child has elevated BMI greater than or equal to 85% for age and sex
• child has ALT value greater than 26 for boys and 22 for girls on two occasions within the last year; OR one elevated ALT value and imaging confirming steatosis
• family does not intend to move out of California for the next year;
• family is not already receiving EatSF Fruit and Vegetable Vouchers;
• family is not participating in any other dietary education programs besides that offered by the liver/ WATCH clinics

You may not qualify if:

• child has an underlying condition or medication causing their weight gain (i.e., hypothyroidism, Prader-Willi syndrome, antipsychotic medications) or a known liver condition other than MASLD/MASH causing their elevated liver numbers;
• child is on a weight loss medication (including: Qsymia or GLP-1 receptor agonists),
• both of which are assessed as part of routine clinical care.

Sponsors & Collaborators

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

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (6)

• 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

• 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

• 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

• 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

• 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

• 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

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sarah L Maxwell, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milagro Escobar

CONTACT

4155197863; milagro.escobar@ucsf.edu

Sarah L Maxwell, MD

CONTACT

4155197863; sarah.maxwell@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• 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): July 30, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)