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Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study

RecruitingNAAges 6 Years - 17 YearsAllUniversity of California, San Francisco
NCT07091539 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 interve

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📋 Eligibility rules (as published)
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.
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What it tests

  • Fruit/vegetable vouchers
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Where

1 site
University of California, San Francisco
San Francisco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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