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New treatment option for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Official title Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
ClinicalTrials.gov ID: NCT07091539
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- The study population for all study aims consists of children and adolescents receiving care at the liver and WATCH clinics. 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
You likely can't join if
- child has an underlying condition or medication causing their weight gain (i.e., hypothyroidism, Prader-Willi syndrome, antipsychotic medications) or...
- 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.
See the full eligibility criteria
- The study population for all study aims consists of children and adolescents receiving care at the liver and WATCH clinics. 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.