Metabolic Dysfunction-associated Steatotic Liver DiseaseNCT06483711
Reducing Barriers to Lifestyle Modification for Newly Diagnosed MASLD
A study testing Lifestyle Kit in people with Metabolic Dysfunction-associated Steatotic Liver Disease, run by Stanford University.
Trial summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common cause of liver disease in the world. It is estimated that 38% of American children with obesity have steatotic liver disease. Patients of Hispanic ethnicity are disproportionately at risk of developing MASLD. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Metabolic Dysfunction-associated Steatotic Liver Disease
- What is being tested?
- Lifestyle Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Jul 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric and adolescent patients age 10-17 years of Hispanic ethnicity and newly diagnosed MASLD (as confirmed by ultrasound or biopsy + cardiometabolic risk factor) in the pediatric hepatology or GI clinic. Patients will also be restricted to patients who live in Alameda, Contra Costa, Solano, San Francisco, San Mateo, and Santa Clara counties due to the limitations of Fresh Approach locations. Families that include one family member who speaks English.
Who cannot join
- Age less than 10 and age greater than 17. Patient who do not live in Alameda, Contra Costa, Solano, San Francisco, San Mateo, and Santa Clara counties due to limitations of Fresh Approach locations. Families with no English Speakers or families whose primary language is not English or Spanish.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing Barriers to Lifestyle Modification for Pediatric Patients of Hispanic Ethnicity and Newly Diagnosed MASLD
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common cause of liver disease in the world. It is estimated that 38% of American children with obesity have steatotic liver disease. Patients of Hispanic ethnicity are disproportionately at risk of developing MASLD. This study intends to provide insight to barriers of recommended care for pediatric patients with Hispanic ethnicity and a new diagnosis of MASLD. The investigators propose to augment existing structural barriers related to health literacy, food accessibility and dietary knowledge, and access to safe physical activity through a healthy lifestyle toolkit and individualized nutritional counseling.
Read the detailed description
The Hispanic population represents the largest and fastest growing ethnic group in the United States. Patients of Hispanic ethnicity are disproportionately at risk of developing MASLD. An adult meta-analysis found a prevalence rate of 22.9% among individuals of Hispanic ethnicity. A pediatric retrospective study found that children who are Hispanic are 5 times more likely to have MASLD than their age/gender matched peers who identify as black. The etiology of why individuals of Hispanic ethnicity are at higher risk of developing MASLD, and subsequently associated co-morbidities such as insulin resistance, diabetes, and cardiovascular disease, is thought to be multifactorial. There is evidence to suggest that individuals of Hispanic ethnicity have a genetic predisposition for hepatic fat infiltration.11 Additionally, it has been postulated that social determinants of health, such as economic stability and health care access and quality contribute to an increased risk.
The American Association for the Study of Liver Diseases (AASLD) recommends lifestyle modification as the foundation of treatment for MASLD. Implementing dietary changes and increasing physical activity contribute to weight loss, which has been found to reduce hepatic steatosis. A 7-10% weight loss can improve histopathological features of MASLD, including fibrosis.Application of dietary modification, such as adherence to the Mediterranean dietary pattern, can decrease hepatic fat content, even in the absence of weight loss.Though lifestyle intervention has been found to be effective, barriers to implementation exist. In a study of adult patients of Hispanic ethnicity with a diagnosis of MASLD, access to nutritious food and a safe exercising environment limited the ability to follow through with recommended lifestyle changes.A survey study of pediatric patients with MASLD found that many lacked the opportunity for physical activity, though the majority expressed an interest in participation.16 Health literacy, or the ability to obtain and comprehend medical information, has also been found to be a barrier to effective care. In a qualitative interview study of adults with MASLD, health literacy was hindered by the availability of liver disease resources in the patient's preferred language. There is limited pediatric data regarding perceived barriers to implementing lifestyle changes. With this study, the investigators hope to minimize some of the social determinants of health that can impact Hispanic pediatric MASLD patients and help them participate in the recommended standard of care.
- Being tested
- Lifestyle Kit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle KitOther
The investigators will provide a kit to families that contains educational information, exercise equipment, and nutritional products.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Lifestyle Kit Group | Experimental | Participants will receive a healthy lifestyle kit and be asked interview questions about its efficacy. Receives: Other: Lifestyle Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Social Determinants of Health Impacting Participants
Social Determinants of Health Screener will identify the presence of food, housing, and/or transportation insecurity.
Measured: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Secondary outcomes (8)
Mean Change from Baseline AST at 3 or 6 month follow-up appointment
AST lab value
Measured: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Mean Change from Baseline ALT at 3 or 6 month follow-up appointment
ALT Lab value
Measured: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Mean Change from Baseline GGT at 3 or 6 month follow-up appointment
GGT Lab value
Measured: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Mean BMI Change from Baseline at 3 or 6 month follow-up appointment
BMI
Measured: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Mean Weight Change from Baseline at 3 or 6 month follow-up appointment
weight
Measured: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Socioeconomic status of Participants participating in the study
Socioeconomic status
Measured: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Ethnic background of Participants participating in the study
ethnic background
Measured: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Primary language of Participants participating in the study
primary language
Measured: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Herdes, Stanford University
- Investigators
- Rachel Herdes, DO, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483711
- Sponsor's protocol ID
- IRB-75991
- Status last verified
- May 2025
- First submitted
- 26 Jun 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There currently are no plans to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Barriers to Lifestyle Modification for Pediatric Patients of Hispanic Ethnicity and Newly Diagnosed MASLD
- ClinicalTrials.gov ID
- NCT06483711
- Acronym / sponsor ID
- IRB-75991
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 3 Jul 2024 (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.
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common cause of liver disease in the world. It is estimated that 38% of American children with obesity have steatotic liver disease. Patients of Hispanic ethnicity are disproportionately at risk of developing MASLD. This study intends to provide insight to barriers of recommended care for pediatric patients with Hispanic ethnicity and a new diagnosis of MASLD. The investigators propose to augment existing structural barriers related to health literacy, food accessibility and dietary knowledge, and access to safe physical activity through a healthy lifestyle toolkit and individualized nutritional counseling.
Detailed description
The Hispanic population represents the largest and fastest growing ethnic group in the United States. Patients of Hispanic ethnicity are disproportionately at risk of developing MASLD. An adult meta-analysis found a prevalence rate of 22.9% among individuals of Hispanic ethnicity. A pediatric retrospective study found that children who are Hispanic are 5 times more likely to have MASLD than their age/gender matched peers who identify as black. The etiology of why individuals of Hispanic ethnicity are at higher risk of developing MASLD, and subsequently associated co-morbidities such as insulin resistance, diabetes, and cardiovascular disease, is thought to be multifactorial. There is evidence to suggest that individuals of Hispanic ethnicity have a genetic predisposition for hepatic fat infiltration.11 Additionally, it has been postulated that social determinants of health, such as economic stability and health care access and quality contribute to an increased risk.
The American Association for the Study of Liver Diseases (AASLD) recommends lifestyle modification as the foundation of treatment for MASLD. Implementing dietary changes and increasing physical activity contribute to weight loss, which has been found to reduce hepatic steatosis. A 7-10% weight loss can improve histopathological features of MASLD, including fibrosis.Application of dietary modification, such as adherence to the Mediterranean dietary pattern, can decrease hepatic fat content, even in the absence of weight loss.Though lifestyle intervention has been found to be effective, barriers to implementation exist. In a study of adult patients of Hispanic ethnicity with a diagnosis of MASLD, access to nutritious food and a safe exercising environment limited the ability to follow through with recommended lifestyle changes.A survey study of pediatric patients with MASLD found that many lacked the opportunity for physical activity, though the majority expressed an interest in participation.16 Health literacy, or the ability to obtain and comprehend medical information, has also been found to be a barrier to effective care. In a qualitative interview study of adults with MASLD, health literacy was hindered by the availability of liver disease resources in the patient's preferred language. There is limited pediatric data regarding perceived barriers to implementing lifestyle changes. With this study, the investigators hope to minimize some of the social determinants of health that can impact Hispanic pediatric MASLD patients and help them participate in the recommended standard of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Lifestyle Kit Group | Experimental | Other: Lifestyle KitParticipants will receive a healthy lifestyle kit and be asked interview questions about its efficacy. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric and adolescent patients age 10-17 years of Hispanic ethnicity and newly diagnosed MASLD (as confirmed by ultrasound or biopsy + cardiometabolic risk factor) in the pediatric hepatology or GI clinic. Patients will also be restricted to patients who live in Alameda, Contra Costa, Solano, San Francisco, San Mateo, and Santa Clara counties due to the limitations of Fresh Approach locations. Families that include one family member who speaks English.
Key exclusion criteria (1 listed)
- Age less than 10 and age greater than 17. Patient who do not live in Alameda, Contra Costa, Solano, San Francisco, San Mateo, and Santa Clara counties due to limitations of Fresh Approach locations. Families with no English Speakers or families whose primary language is not English or Spanish.
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 |
|---|---|---|
| Lifestyle KitThe investigators will provide a kit to families that contains educational information, exercise equipment, and nutritional products. | Other | Healthy Lifestyle Kit Group |
Primary outcome
Number of Social Determinants of Health Impacting Participants
Time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Social Determinants of Health Screener will identify the presence of food, housing, and/or transportation insecurity.
8 secondary outcomes
Mean Change from Baseline AST at 3 or 6 month follow-up appointment
Time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Mean Change from Baseline ALT at 3 or 6 month follow-up appointment
Time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Mean Change from Baseline GGT at 3 or 6 month follow-up appointment
Time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Mean BMI Change from Baseline at 3 or 6 month follow-up appointment
Time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Mean Weight Change from Baseline at 3 or 6 month follow-up appointment
Time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Socioeconomic status of Participants participating in the study
Time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Ethnic background of Participants participating in the study
Time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Primary language of Participants participating in the study
Time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
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 13 May 2025.
- Individual participant dataSharing planned: No. There currently are no plans to share IPD.
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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.
Rachel Herdes, DO principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Kit in people with Metabolic Dysfunction-associated Steatotic Liver Disease, run by Stanford University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Rachel Herdes, DO (650-497-8911, rherdes@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Social Determinants of Health Impacting Participants (time frame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025.