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

N/AEnrolling By InvitationNCT07199491

The University of Texas Health Science Center, Houston64 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Metabolic-dysfunction Associated Liver Disease (MASLD)

Interventions

Healthy Liver/Hígado Sano programBEHAVIORAL

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.

Usual CareBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Recruitment Feasibility

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

Time frame: Baseline

Retention

Percent of participants who complete follow-up data collection

Time frame: 6 months, 12 months

Adherence

Intervention participants who attend education sessions

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

Self-reported Physical Activity

The International Physical Activity Questionnaire(IPAQ) is a 27-item questionnaire assessing the frequency (days per week) and duration (minutes per day) of physical activities across four domains: work, transportation, household/gardening, and leisure-time, as well as time spent sitting. Physical activity scores are calculated in metabolic equivalent task minutes per week (MET-minutes/week) by multiplying activity intensity (Walking = 3.3 METs, Moderate = 4.0 METs, Vigorous = 8.0 METs) × duration × frequency within each domain. Total physical activity is obtained by summing across all domains, and respondents are classified into Low, Moderate, or High activity categories according to standardized IPAQ scoring guidelines.

Time frame: Baseline, 6 months, 12 months

Accelerometer-assessed physical activity

Data from ClinicalTrials.gov

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