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

N/ANot Yet RecruitingNCT07199491

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

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 weekly classes over the 6-month period. This consists of 16 core sessions delivered in the first 6 months (weekly, but with flexibility to skip weeks as necessary due to holidays, etc). The sessions are 30-60 minutes long, conducted in a group setting, with a CDC-certified Lifestyle Coach facilitating the sessions.

Usual CareBEHAVIORAL

participants will first complete a 30- to 45-minute questionnaire that will cover topics such as physical activity, diet, alcohol use, and stress.Participants will then be asked to wear an accelerometer for 7 days and complete a log to identify when it was worn and removed each day.Height and weight will also be measured and a Fibroscan® assessment (to measure amount of fat and scar tissue in the liver), as well as blood work to monitor the liver enzymes will be done

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Self-reported Hispanic/Latino * Have been diagnosed with MASLD * Able to speak English or Spanish * 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: * Does not have a working telephone number

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Feasibility as assessed by the number of participants recruited

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

Time frame: Baseline

Number of participants that completed the study

Time frame: 6 months

Number of participants that completed the study

Time frame: 12 months

Number of participants that adhered to the protocol

Time frame: 6 months

Number of participants that adhered to the protocol

Time frame: 12 months

Participant satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8)

The 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

Change in physical activity using the self-reported International Physical Activity Questionnaire(IPAQ)

This 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.

Central Contacts

Natalia Heredia

CONTACT

(713) 500 9600 Natalia.I.Heredia@uth.tmc.edu

Data from ClinicalTrials.gov

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