Food insecurity is a risk factor for metabolic dysfunction-associated steatotic liver disease in Latinx children.
Sarah L Maxwell, Jennifer C Price, Emily R Perito...
https://pubmed.ncbi.nlm.nih.gov/38453472Actively Recruiting
Phase Not Applicable
Age: 6Years - 17Years
All Genders
ID07091539
Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
Led by University of California, San Francisco · Updated on 2025-09-02
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
A
American Gastroenterological Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effect of household food insecurity on the severity of metabolic dysfunction-associated steatotic liver disease (MASLD) in children and adolescents. Previous studies link food insecurity to more severe MASLD and liver fibrosis in adults, and early childhood exposure to food insecurity increases the risk of pediatric MASLD. Since managing MASLD focuses on diet and exercise, this study explores whether providing fruit and vegetable vouchers can improve health outcomes for children with MASLD living in food-insecure households. The study involves a 6-month pilot intervention where families receive $80 worth of fruit and vegetable vouchers each month. Participants are children with MASLD and household food insecurity receiving care at specialty clinics. The researchers will track voucher redemption and conduct interviews to understand challenges and supports related to using vouchers, following dietary advice, and parental knowledge about MASLD and diet. Data on dietary changes, liver inflammation, and cardiometabolic health factors will be collected before and after the intervention. Children and families will participate in assessments at the start and end of the 6-month period, including blood tests measuring liver inflammation and surveys on diet. The research team will monitor voucher use through software and conduct interviews with parents or guardians to identify barriers and facilitators to healthy eating. The study aims to inform future larger trials to evaluate this intervention's impact on pediatric MASLD and related health outcomes.
CONDITIONS
Brief Title
Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
Who Can Participate
Age: 6Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children and adolescents receiving care at the liver and WATCH clinics
- Family living in California
- Parent or guardian speaks Spanish or English
- Child is between 6 and less than 18 years old
- Child has BMI at or above the 85th percentile for age and sex
- Child has elevated ALT values: greater than 26 for boys and 22 for girls on two occasions within the last year, or one elevated ALT and imaging confirming steatosis
- Family does not plan to move out of California for the next year
- Family is not currently receiving EatSF Fruit and Vegetable Vouchers
- Family is not participating in other dietary education programs besides those offered by liver or WATCH clinics
You will not qualify if you...
- Child has an underlying condition or medication causing weight gain (e.g., hypothyroidism, Prader-Willi syndrome, antipsychotic medications)
- Child has a liver condition other than MASLD or MASH causing elevated liver numbers
- Child is taking weight loss medications including Qsymia or GLP-1 receptor agonists
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive $80 of fruit and vegetable vouchers each month for 6 months as part of the EatSF Vouchers4Veggies program.
Monthly visits for 6 months
Follow-up
Duration - 1 visit
At the end of the 6-month intervention, participants complete study assessments and parents or guardians participate in semi-structured interviews about voucher use, dietary adherence, and understanding of MASLD.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
Loading map...
Research Team
M
Milagro Escobar
S
Sarah L Maxwell, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Child-Report of Food Insecurity Is Associated with Diet Quality in Children.
Matthew J Landry, Alexandra E van den Berg, Fiona M Asigbee...
https://pubmed.ncbi.nlm.nih.gov/31336880Racial and ethnic differences in diet quality and food insecurity among adults with fatty liver and significant fibrosis: a U.S. population-based study.
Ani Kardashian, Jennifer L Dodge, Norah A Terrault
https://pubmed.ncbi.nlm.nih.gov/36173037Food Insecurity is Associated With Mortality Among U.S. Adults With Nonalcoholic Fatty Liver Disease and Advanced Fibrosis.
Ani Kardashian, Jennifer L Dodge, Norah A Terrault
https://pubmed.ncbi.nlm.nih.gov/34958747Food insecurity is associated with magnetic resonance-determined nonalcoholic fatty liver and liver fibrosis in low-income, middle-aged adults with and without HIV.
Javier A Tamargo, Kenneth E Sherman, Adriana Campa...
https://pubmed.ncbi.nlm.nih.gov/33515016Food Insecurity May Be an Independent Risk Factor Associated with Nonalcoholic Fatty Liver Disease among Low-Income Adults in the United States.
Ilya Golovaty, Phyllis C Tien, Jennifer C Price...
https://pubmed.ncbi.nlm.nih.gov/31504710