48 Participants Needed

Fruit and Vegetable Vouchers for Fatty Liver Disease in Children

ME
SL
Overseen BySarah L Maxwell, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fruit and vegetable vouchers can improve liver health in children and teens with fatty liver disease linked to food insecurity. The goal is to determine if better access to healthy foods can reduce the severity of this liver condition and enhance overall health. Children diagnosed with fatty liver disease, experiencing hunger due to food shortages at home, and receiving treatment at specific clinics in California may qualify. The trial provides $80 in vouchers each month for six months to purchase fruits and vegetables. The outcomes will inform a larger future study. As an unphased trial, this study allows participants to contribute to important research that could lead to better health solutions for children facing similar challenges.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if your child is on weight loss medications or medications causing weight gain, they may not be eligible to participate.

What prior data suggests that this fruit/vegetable voucher intervention is safe for children with MASLD?

Research has shown that distributing fruit and vegetable vouchers can improve diet quality. These programs aim to assist families who struggle to afford enough food by enabling them to eat more healthily. Past studies have not reported any negative effects from using these vouchers; instead, they help children and families consume more fruits and vegetables.

Since this trial uses fruit and vegetable vouchers, it does not involve any new drugs or medical procedures, resulting in a very low risk of harmful side effects. The vouchers serve as a means to encourage healthier eating habits, which are generally safe and beneficial for health.12345

Why are researchers excited about this trial?

Researchers are excited about using fruit and vegetable vouchers as a treatment for fatty liver disease in children because it takes a novel approach by addressing diet and food access rather than relying on medications or lifestyle advice alone. Unlike current treatments that often focus on medication and weight management, this method directly improves the nutritional intake of children in food-insecure households, potentially reducing liver fat. By providing $80 worth of vouchers per month, families can access healthier food options, which might lead to significant improvements in liver health and overall well-being. This approach is promising because it targets a root cause—diet quality—making it a potentially sustainable and impactful solution for managing fatty liver disease in children.

What evidence suggests that fruit/vegetable vouchers might be an effective treatment for fatty liver disease in children?

Research has shown that a lack of healthy food at home is linked to more severe cases of pediatric metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as non-alcoholic fatty liver disease, in children. Studies suggest that children in food-insecure homes often consume fewer fruits and vegetables and more unhealthy, high-calorie foods, worsening liver problems. Early findings indicate that providing families with vouchers for fruits and vegetables could improve the diet and health of children with MASLD. In this trial, participants will receive $80 in fruit and vegetable vouchers per month for six months. By improving access to healthy foods, the researchers aim to lessen the severity of liver disease in these children.23467

Who Is on the Research Team?

SL

Sarah L Maxwell, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for children and adolescents who are experiencing food insecurity and have been diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD). They must be receiving care at UCSF's liver clinic or the WATCH Clinic. The study aims to help those struggling with poor access to healthy foods.

Inclusion Criteria

Family living in California
Family does not intend to move out of California for the next year
My child has had high ALT levels or one high ALT level with confirmed fatty liver.
See 6 more

Exclusion Criteria

My child's weight gain or liver issues are due to a specific condition or medication.
My child is taking medication for weight loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive $80 of fruit/vegetable vouchers per month for 6 months

6 months
Monthly voucher distribution

Assessment

Assess changes in dietary intake, liver inflammation, and other cardiometabolic health factors

6 months
End of study assessments

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fruit/Vegetable Vouchers
Trial Overview The trial is testing a fruit/vegetable voucher program called EatSF, designed to improve diet quality and health outcomes in young patients with MASLD affected by household food insecurity. It will evaluate how well participants can use these vouchers and if their dietary habits, MASLD severity, and overall cardiometabolic health improve.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Children with MASLD and food insecurityExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

American Gastroenterological Association

Collaborator

Trials
6
Recruited
4,400+

University of California, San Francisco Population Health Health Equity Award

Collaborator

Citations

Pediatric Metabolic Dysfunction-associated Steatotic Liver ...This proposal addresses a critical gap in our understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated ...
UCSF Liver Disease Trial → Food Insecurity and MASLDThe study seeks to identify barriers and facilitators to fruit/vegetable voucher redemption, and assess changes in dietary intake, MASLD severity, and other ...
Fruit and Vegetable Vouchers for Fatty Liver Disease in ...This trial is for children and adolescents who are experiencing food insecurity and have been diagnosed with metabolic dysfunction-associated steatotic liver ...
Optimal Vegetable Intake for Metabolic-Dysfunction ...Metabolic-dysfunction-associated steatotic liver disease (MASLD), previously named non-alcoholic fatty liver disease (NAFLD), is defined as the ...
Understanding Food Insecurity's Impact on Liver Disease in ...This important study led by researchers at UCSF will examine how food insecurity affects liver disease severity in children with MASLD, and ...
Food Insecurity and MASLD: A Fruit and Vegetable ...The study seeks to identify barriers and facilitators to fruit/vegetable voucher redemption, and assess changes in dietary intake, MASLD severity, and other ...
Impact of a Fruit and Vegetable Prescription Program on ...We assessed the impact of a fruit and vegetable prescription program on the health outcomes and behaviors of participating children.
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