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NCT07091539 · ClinicalTrials.gov registry record · NA
Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
A NA study of MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Food Insecurity Among Children, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT07091539: Recruiting NA study of MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Food Insecurity Among Children, sponsored by University of California, San Francisco.
NCT07091539 is a NA study of MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Food Insecurity Among Children that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 48 participants, below the 95-participant average among 5 other MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07091539, a NA study of MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Food Insecurity Among Children, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
What percentage of money of the vouchers were used monthly
Conditions Studied
Interventions
- OTHER Fruit/vegetable vouchers
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2025-07-30 |
| Est. Completion | 2027-08 |
| Phase | NA |
What NCT07091539 shows while recruiting
NCT07091539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 95-participant average among 5 other MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease trials with a reported enrollment target (49% lower).
The record links to 2 conditions, with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease appearing as the primary indexed condition, and to 1 intervention - of which Fruit/vegetable vouchers is the first listed.
NCT07091539 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07091539 about?
NCT07091539 is a clinical study titled "Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study". 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...
What is the current status of trial NCT07091539?
This trial is currently recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2025-07-30. Estimated completion is 2027-08.
What conditions does trial NCT07091539 study?
This clinical trial studies the following conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Food Insecurity Among Children.
What interventions are being tested in trial NCT07091539?
The interventions under investigation include: Fruit/vegetable vouchers (OTHER).
Who is sponsoring clinical trial NCT07091539?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07091539 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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