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

NCT07199491 | Enrolling By Invitation

• 2 other identifiers: HSC-SPH-25-0539K01MD019149
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Metabolic-dysfunction Associated Liver Disease (MASLD)

Keywords

weight loss; alcohol consumption; Diabetes Prevention Program (DPP)

Outcome Measures

Primary Outcomes (4)

• Recruitment Feasibility

  Recruitment will be assessed to be feasible if ≥65% of eligible participants enroll in the study

  Baseline

• Retention

  Percent of participants who complete follow-up data collection

  6 months, 12 months

• Adherence

  Intervention participants who attend education sessions

  6 months

• Participant satisfaction

  The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report instrument assessing satisfaction with services received. Each item is rated on a 4-point Likert scale (1 = least satisfied, 4 = most satisfied). Item scores are summed to produce a total score ranging from 8 to 32, with higher scores indicating greater satisfaction.

  6 months

Secondary Outcomes (6)

• Self-reported Physical Activity

  Baseline, 6 months, 12 months

• Accelerometer-assessed physical activity

  Baseline, 6 months, 12 months

• Diet

  Baseline, 6 months, 12 months

• Weight

  Baseline, 6 months, 12 months

• Liver steatosis and/or stiffness

  Baseline, 6 months, 12 months

Study Arms (2)

Healthy Liver/Hígado Sano program

EXPERIMENTAL

Behavioral: Healthy Liver/Hígado Sano program

Usual Care

ACTIVE COMPARATOR

Behavioral: Usual Care

Interventions

Healthy Liver/Hígado Sano program BEHAVIORAL

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.

Healthy Liver/Hígado Sano program

Usual Care BEHAVIORAL

Observational clinic participants receive usual care, which can include referrals to dieticians and/or specialists.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported Hispanic/Latino
• Have been diagnosed with MASLD
• Be an adult \>= 18 years of age
• Able to speak English or Spanish
• Have a working telephone number
• Have access to internet, either on their phone, at home or at some other location convenient to the participant
• Have a family member willing to attend all sessions

You may not qualify if:

• Taking a GLP-1 receptor agonist or dual agonist at the time of enrollment, or plans to being taking one in the next 6 months

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Weight Loss; Alcohol Drinking

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drinking Behavior; Behavior

Study Officials

• Natalia Heredia

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 30, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)