Clinical trial NCT06483711: Reducing Barriers to Lifestyle Modification for Newly Diagnosed MASLD
Official title: Reducing Barriers to Lifestyle Modification for Pediatric Patients of Hispanic Ethnicity and Newly Diagnosed MASLD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Social Determinants of Health Impacting Participants
timeFrame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Secondary outcomes:
measure: Mean Change from Baseline AST at 3 or 6 month follow-up appointment
timeFrame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
measure: Mean Change from Baseline ALT at 3 or 6 month follow-up appointment
timeFrame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
measure: Mean Change from Baseline GGT at 3 or 6 month follow-up appointment
timeFrame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
measure: Mean BMI Change from Baseline at 3 or 6 month follow-up appointment
timeFrame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
measure: Mean Weight Change from Baseline at 3 or 6 month follow-up appointment
timeFrame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
measure: Socioeconomic status of Participants participating in the study
timeFrame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
measure: Ethnic background of Participants participating in the study
timeFrame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
measure: Primary language of Participants participating in the study
timeFrame: Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Rachel Herdes, DO
role: PRINCIPAL_INVESTIGATOR
References: