MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07091539
Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
A study testing Fruit/vegetable vouchers in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Food Insecurity Among Children, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Food Insecurity Among Children
- What is being tested?
- Fruit/vegetable vouchers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
About this 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 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.
Read the detailed description
Study designs for each of the three specific aims are below:
Aim 1: Assess participation in the EatSF intervention (to be piloted in the liver and WATCH clinics) among families with a child with MASLD and household FI, as identified through an observational cross-sectional study.
Design: To achieve this aim, the investigators will conduct a 6-month pre-post one-arm pilot intervention study of the EatSF Vouchers4Veggies fruit and voucher program with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics. At the end of the 6-month intervention period, the investigators will assess the percentage of vouchers redeemed through a software program developed by EatSF Vouchers4Veggies. Also at the end of the 6-month intervention, the CRC will administer study assessments comparable to those conducted at baseline as part of the observational cross-sectional study (for which IRB approval has been submitted). Also at the end of the 6-month intervention, the CRC will conduct semi-structured interviews to identify barriers and facilitators to:
- voucher redemption,
- adhering to clinic dietary recommendations, and
- parental understanding of MASLD and the role of diet in its management.
Aim 2: Assess changes in dietary intake in children with MASLD and FI participating in the 6-month pre-post one-arm pilot intervention study with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics (projected n=48).
Design: To achieve this aim, the investigators will analyze changes in the baseline data collected as part of the observational cross-sectional study (for which IRB approval has been submitted) with post-test data (collected at the end of the six-month pilot study).
Exploratory Aim 3: Assess changes in liver inflammation measured by alanine aminotransferase serum lab (ALT) (GGT), and other cardiometabolic health factors in children with MASLD and household FI from baseline to the end of the 6-month study.
Design: To achieve this aim, the investigators will analyze data collected from the 6-month pre-post one-arm pilot intervention study with families with a child with household FI and MASLD who receive care at UCSF's liver and WATCH clinics.
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Food Insecurity Among Children
- Being tested
- Fruit/vegetable vouchers
- Keywords
- MASLD, Food insecurity, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit/vegetable vouchersOther
The intervention is $80 of fruit/vegetable vouchers (EatSF Veggies4Vouchers) per month x 6 months
| Study group | Role | What they receive |
|---|---|---|
| Children with MASLD and food insecurity | Experimental | This group will receive $80 of fruit/vegetable vouchers per month x 6 months; parents/ guardians will participate in a semi-structured interview at the end of the study Receives: Other: Fruit/vegetable vouchers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voucher participation
What percentage of money of the vouchers were used monthly
Measured: From enrollment to the end of the six month intervention
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.
Measured: From baseline to the end of the six month intervention
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.
Measured: From baseline to the end of the six months study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start30 Jul 2025
- Primary completion30 Jul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Gastroenterological Association
- Responsible party
- Sponsor
- Investigators
- Sarah L Maxwell, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091539
- Sponsor's protocol ID
- 24-42019
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maxwell SL, Price JC, Perito ER, Rosenthal P, Wojcicki JM. Food insecurity is a risk factor for metabolic dysfunction-associated steatotic liver disease in Latinx children. Pediatr Obes. 2024 Jun;19(6):e13109. doi: 10.1111/ijpo.13109. Epub 2024 Mar 7.
PubMed 38453472Landry MJ, van den Berg AE, Asigbee FM, Vandyousefi S, Ghaddar R, Davis JN. Child-Report of Food Insecurity Is Associated with Diet Quality in Children. Nutrients. 2019 Jul 12;11(7):1574. doi: 10.3390/nu11071574.
PubMed 31336880Kardashian A, Dodge JL, Terrault NA. Racial and ethnic differences in diet quality and food insecurity among adults with fatty liver and significant fibrosis: a U.S. population-based study. Aliment Pharmacol Ther. 2022 Nov;56(9):1383-1393. doi: 10.1111/apt.17219. Epub 2022 Sep 29.
PubMed 36173037Kardashian A, Dodge JL, Terrault NA. Food Insecurity is Associated With Mortality Among U.S. Adults With Nonalcoholic Fatty Liver Disease and Advanced Fibrosis. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2790-2799.e4. doi: 10.1016/j.cgh.2021.11.029. Epub 2021 Dec 16.
PubMed 34958747Tamargo JA, Sherman KE, Campa A, Martinez SS, Li T, Hernandez J, Teeman C, Mandler RN, Chen J, Ehman RL, Baum MK. Food insecurity is associated with magnetic resonance-determined nonalcoholic fatty liver and liver fibrosis in low-income, middle-aged adults with and without HIV. Am J Clin Nutr. 2021 Mar 11;113(3):593-601. doi: 10.1093/ajcn/nqaa362.
PubMed 33515016Golovaty I, Tien PC, Price JC, Sheira L, Seligman H, Weiser SD. Food Insecurity May Be an Independent Risk Factor Associated with Nonalcoholic Fatty Liver Disease among Low-Income Adults in the United States. J Nutr. 2020 Jan 1;150(1):91-98. doi: 10.1093/jn/nxz212.
PubMed 31504710
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study
- ClinicalTrials.gov ID
- NCT07091539
- Acronym / sponsor ID
- 24-42019
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Food Insecurity Among Children
- Keywords
- MASLD, Food insecurity, pediatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Gastroenterological Association
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study designs for each of the three specific aims are below:
Aim 1: Assess participation in the EatSF intervention (to be piloted in the liver and WATCH clinics) among families with a child with MASLD and household FI, as identified through an observational cross-sectional study.
Design: To achieve this aim, the investigators will conduct a 6-month pre-post one-arm pilot intervention study of the EatSF Vouchers4Veggies fruit and voucher program with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics. At the end of the 6-month intervention period, the investigators will assess the percentage of vouchers redeemed through a software program developed by EatSF Vouchers4Veggies. Also at the end of the 6-month intervention, the CRC will administer study assessments comparable to those conducted at baseline as part of the observational cross-sectional study (for which IRB approval has been submitted). Also at the end of the 6-month intervention, the CRC will conduct semi-structured interviews to identify barriers and facilitators to:
- voucher redemption,
- adhering to clinic dietary recommendations, and
- parental understanding of MASLD and the role of diet in its management.
Aim 2: Assess changes in dietary intake in children with MASLD and FI participating in the 6-month pre-post one-arm pilot intervention study with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics (projected n=48).
Design: To achieve this aim, the investigators will analyze changes in the baseline data collected as part of the observational cross-sectional study (for which IRB approval has been submitted) with post-test data (collected at the end of the six-month pilot study).
Exploratory Aim 3: Assess changes in liver inflammation measured by alanine aminotransferase serum lab (ALT) (GGT), and other cardiometabolic health factors in children with MASLD and household FI from baseline to the end of the 6-month study.
Design: To achieve this aim, the investigators will analyze data collected from the 6-month pre-post one-arm pilot intervention study with families with a child with household FI and MASLD who receive care at UCSF's liver and WATCH clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with MASLD and food insecurity | Experimental | Other: Fruit/vegetable vouchersThis group will receive $80 of fruit/vegetable vouchers per month x 6 months; parents/ guardians will participate in a semi-structured interview at the end of the study |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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;
- child has elevated BMI greater than or equal to 85% for age and sex
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit/vegetable vouchersThe intervention is $80 of fruit/vegetable vouchers (EatSF Veggies4Vouchers) per month x 6 months | Other | Children with MASLD and food insecurity |
Primary outcome
Voucher participation
Time frame: From enrollment to the end of the six month intervention
What percentage of money of the vouchers were used monthly
Changes in dietary intake
Time frame: From baseline to the end of the six month intervention
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
Time frame: From baseline to the end of the six months study.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 38453472Maxwell SL, Price JC, Perito ER, Rosenthal P, Wojcicki JM. Food insecurity is a risk factor for metabolic dysfunction-associated steatotic liver disease in Latinx children. Pediatr Obes. 2024 Jun;19(6):e13109. doi: 10.1111/ijpo.13109. Epub 2024 Mar 7.
- Background: PubMed 31336880Landry MJ, van den Berg AE, Asigbee FM, Vandyousefi S, Ghaddar R, Davis JN. Child-Report of Food Insecurity Is Associated with Diet Quality in Children. Nutrients. 2019 Jul 12;11(7):1574. doi: 10.3390/nu11071574.
- Background: PubMed 36173037Kardashian A, Dodge JL, Terrault NA. Racial and ethnic differences in diet quality and food insecurity among adults with fatty liver and significant fibrosis: a U.S. population-based study. Aliment Pharmacol Ther. 2022 Nov;56(9):1383-1393. doi: 10.1111/apt.17219. Epub 2022 Sep 29.
- Background: PubMed 34958747Kardashian A, Dodge JL, Terrault NA. Food Insecurity is Associated With Mortality Among U.S. Adults With Nonalcoholic Fatty Liver Disease and Advanced Fibrosis. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2790-2799.e4. doi: 10.1016/j.cgh.2021.11.029. Epub 2021 Dec 16.
- Background: PubMed 33515016Tamargo JA, Sherman KE, Campa A, Martinez SS, Li T, Hernandez J, Teeman C, Mandler RN, Chen J, Ehman RL, Baum MK. Food insecurity is associated with magnetic resonance-determined nonalcoholic fatty liver and liver fibrosis in low-income, middle-aged adults with and without HIV. Am J Clin Nutr. 2021 Mar 11;113(3):593-601. doi: 10.1093/ajcn/nqaa362.
- Background: PubMed 31504710Golovaty I, Tien PC, Price JC, Sheira L, Seligman H, Weiser SD. Food Insecurity May Be an Independent Risk Factor Associated with Nonalcoholic Fatty Liver Disease among Low-Income Adults in the United States. J Nutr. 2020 Jan 1;150(1):91-98. doi: 10.1093/jn/nxz212.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah L Maxwell, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit/vegetable vouchers in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Food Insecurity Among Children, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milagro Escobar (4155197863, milagro.escobar@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voucher participation (time frame: From enrollment to the end of the six month intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07091539, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.