About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Fruit/vegetable vouchers
Other interventionThe intervention is $80 of fruit/vegetable vouchers (EatSF Veggies4Vouchers) per month x 6 months
Treatment groups
Trial outcomes
Primary outcomes
Voucher participation
What percentage of money of the vouchers were used monthly
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.
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.
Other outcomes
Semi-structured interviews
At the end of the six months, semi-structured interviews will be conducted to identify barriers and facilitators to voucher redemption, adhering to clinic recommendations, and to explore the parental understanding of MASLD and the role of diet in its management.
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
American Gastroenterological Association
Collaborator