Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07091539
• Lead Sponsor: University of California, San Francisco

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. 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 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 a R01 application to conduct a fully powered randomized controlled trial of the intervention.

Detailed Description

Study designs for each of the three specific aims are below:

Aim 1: Assess participation in the EatSF intervention (to be piloted in the liver and WATCH clinics) among families with a child with MASLD and household FI, as identified through an observational cross-sectional study Design: To achieve this aim, we will conduct a 6-month pre-post one arm pilot intervention study of the Eat SF Vouchers4Veggies fruit and voucher program with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics. At the end of the 6-month intervention period, we will assess the percentage of vouchers redeemed through a software program developed by EatSF Vouchers4Veggies. Also at the end of the 6-month intervention, the CRC will administer study assessments comparable to those conducted at baseline as part of the observational cross-sectional study (for which IRB approval has been submitted). Also at the end of the 6-month intervention, the CRC will conduct semi-structured interviews to identify barriers and facilitators to a) voucher redemption, b) adhering to clinic dietary recommendations, and c) to explore parental understanding of MASLD and the role of diet in its management.

Aim 2: Assess changes in dietary intake in children with MASLD and FI participating in the 6- month pre-post one arm pilot intervention study with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics (projected n= 48) Design: To achieve this aim, I will analyze changes in the baseline data collected as part of the observational cross-sectional study (for which IRB approval has been submitted) with post-test data (collected at the end of the six-month pilot study).

Exploratory Aim 3: Assess changes in liver inflammation measured by alanine aminotransferase serum lab (ALT)(GGT), and other cardiometabolic health factors in children with MASLD and household FI from baseline to the end of the 6 months study.

Design: To achieve this aim, I will analyze data collected from the 6-month pre-post one arm pilot intervention study with families with a child with household FI and MASLD who receive care the UCSF's liver and WATCH clinics.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study Start: 2025-07-23
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Primary Completion: 2027-07-30
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• The study population for all study aims consists of children and adolescents receiving care at the liver and WATCH clinics.

Inclusion criteria include:

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Voucher participation	From enrollment to the end of the six month intervention	What percentage of money of the vouchers were used monthly
Changes in dietary intake	From baseline to the end of the six month intervention	Assess changes in dietary intake in children with MASLD and FI participating in the 6 month pre-post one arm pilot intervention studies.
changes in liver inflammation and other cardiometabolic health factors	From baseline to the end of the six months study.	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States