NCT07199491

Testing a Multilevel, Culturally Appropriate Lifestyle Intervention For Hispanic Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

Testing a Multilevel, Culturally Appropriate Lifestyle Intervention For Hispanic Patients With Metabolic Dysfunction-Associated Steatotic Liver DiseaseTesting a Multilevel, Culturally Appropriate Lifestyle Intervention For Hispanic Patients With Metabolic-dysfunction Associated Steatotic Liver Disease

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand if a behavioral lifestyle intervention called the Healthy Liver/Hígado Sano program can help Hispanic/Latino patients with metabolic dysfunction associated steatotic liver disease (MASLD), also known as non-alcoholic fatty liver disease (NAFLD), lose weight and improve their liver health

Detailed description

This feasibility study will use a quasi-experimental design to test an adapted multilevel intervention with Hispanic/Latino adults with metabolic dysfunction-associated steatotic liver disease at an intervention clinic, compared to similar participants at an observational clinic receiving usual care. The investigators will collect and analyze quantitative and qualitative data, specifically, clinical/biometric, anthropometric, behavioral, and psychosocial assessments at baseline, 6, and 12 months at the individual level, and additionally collect data from family members, providers/staff, and community health workers/social workers. At the end of the study, the investigators will also conduct in-depth interviews to contextualize quantitative results and gain deeper insights into intervention experiences.

Conditions

• Metabolic-dysfunction Associated Liver Disease (MASLD)

Interventions

Type	Name	Description
BEHAVIORAL	Healthy Liver/Hígado Sano program	Participants will attend 16 educational classes over a 6-month period. These sessions are facilitated by a lifestyle coach in a group setting and last about an hour. Family members attend the sessions with the participant. Additionally, providers and staff at the clinic receive training on MASLD background information, including MASLD management, and motivational interviewing. Clinic community health workers and/or social workers assess participants for unmet social needs and refer as appropriate to social services.
BEHAVIORAL	Usual Care	Observational clinic participants receive usual care, which can include referrals to dieticians and/or specialists.

Timeline

• Start date: 2026-01-29
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2025-09-30
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States