Reducing Barriers to Lifestyle Modification for Newly Diagnosed MASLD

NCT06483711 | Not Yet Recruiting

• 1 other identifier: IRB-75991
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mean Change from Baseline AST at 3 or 6 month follow-up appointment

  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

  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

  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

  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

  Baseline and month 3 or 6 depending on when the participant's follow up appointment with the physician is scheduled.

Study Arms (1)

Healthy Lifestyle Kit Group

EXPERIMENTAL

Participants will receive a healthy lifestyle kit and be asked interview questions about its efficacy.

Other: Lifestyle Kit

Interventions

Lifestyle Kit OTHER

The investigators will provide a kit to families that contains educational information, exercise equipment, and nutritional products.

Healthy Lifestyle Kit Group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Officials

• Rachel Herdes, DO

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Herdes, DO

CONTACT

650-497-8911; rherdes@stanford.edu

Amrita Narang, MD

CONTACT

650-497-8911; anarang@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CLINICAL ASSISTANT PROFESSOR, PEDIATRICS - GASTROENTEROLOGY

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share