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

Not Applicable

Not yet recruiting

• Conditions: Metabolic-dysfunction Associated Liver Disease (MASLD)

• Registration Number: NCT07199491
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-21
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30
• Study Start: 2025-10-01
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed by the number of participants recruited	Baseline	Recruitment will be assessed to be feasible if ≥65% of eligible participants enroll in the study
Number of participants that completed the study	12 months
Number of participants that adhered to the protocol	12 months
Participant satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in diet as assessed by the National Cancer Institute's Family Life, Activity, Sun, Health, and Eating (FLASHE) dietary screener self reported questionnaire	Baseline, 6 months, 12 months	This is a 27-item questionnaire that captures past 7-day consumption of fast and junk foods, sugary foods/desserts, fruits and vegetables, and sugar-sweetened beverages. Each item is scored based on reported frequency (ranging from "Never" to "2 or more times per day"). For each food category, responses are converted to frequency per day. Higher frequencies indicate greater reported intake of that food category
Change in fasting glucose levels	Baseline, 6 months, 12 months
Change in weight	Baseline, 6 months, 12 months
Change in liver steatosis (fatty liver disease) and/or stiffness using liver enzyme information using blood draws	Baseline, 6 months, 12 months
Change in Liver steatosis (fatty liver disease) and/or stiffness assessed using the Fibroscan data	Baseline, 6 months, 12 months
Change in physical activity using the self-reported International Physical Activity Questionnaire(IPAQ)	Baseline, 6 months, 12 months	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.
Change in physical activity as assessed by the Actigraph GT9X accelerometers	Baseline, 6 months, 12 months

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States