Actively Recruiting

Phase Not Applicable
Age: 6Years - 17Years
All Genders
NCT07091539

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

104 weeks

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

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

Official Title

Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents receiving care at the UCSF liver or WATCH clinics
  • Family lives in California
  • Parent or guardian speaks Spanish or English
  • Child is aged 6 to under 18 years
  • Child has a BMI at or above the 85th percentile for age and sex
  • Child has elevated ALT liver enzyme levels (greater than 26 for boys and 22 for girls) on two occasions within the last year, or one elevated ALT plus imaging confirming liver fat
  • 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 the liver or WATCH clinics
Not Eligible

You will not qualify if you...

  • Child has medical conditions or medications causing weight gain, such as hypothyroidism, Prader-Willi syndrome, or antipsychotic medications
  • Child has liver diseases other than MASLD or MASH causing elevated liver enzymes
  • Child is currently 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

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

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Research Team

M

Milagro Escobar

CONTACT

S

Sarah L Maxwell, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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