Reducing Barriers to Lifestyle Modification for Newly Diagnosed MASLD

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
• Intervention / Treatment: Other: Lifestyle Kit

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Herdes, DO; Phone Number: 650-497-8911; Email: rherdes@stanford.edu
• Study Contact Backup: Name: Amrita Narang, MD; Phone Number: 650-497-8911; Email: anarang@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Lifestyle Kit Group; Participants will receive a healthy lifestyle kit and be asked interview questions about its efficacy.	Other: Lifestyle Kit; The investigators will provide a kit to families that contains educational information, exercise equipment, and nutritional products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Social Determinants of Health Impacting Participants	Social Determinants of Health Screener will identify the presence of food, housing, and/or transportation insecurity.	Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline AST at 3 or 6 month follow-up appointment	AST lab value	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	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	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	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	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	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	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	Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Rachel Herdes, DO, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: IRB-75991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There currently are no plans to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No