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Enrolling by Invitation

NCT Number: NCT07199491

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

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

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Key information

Conditions

Metabolic-dysfunction Associated Liver Disease (MASLD) Alcohol Drinking Behavior Body Weight Body Weight Changes Drinking Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Behavioral

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

Primary outcomes

  1. Recruitment Feasibility

    Time frame: Baseline

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

  2. Retention

    Time frame: 6 months, 12 months

    Percent of participants who complete follow-up data collection

  3. Adherence

    Time frame: 6 months

    Intervention participants who attend education sessions

  4. Participant satisfaction

    Time frame: 6 months

    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.

Secondary outcomes

  1. Self-reported Physical Activity

    Time frame: Baseline, 6 months, 12 months

    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.

  2. Accelerometer-assessed physical activity

    Time frame: Baseline, 6 months, 12 months

    As assessed by the Actigraph GT9X accelerometers

  3. Diet

    Time frame: Baseline, 6 months, 12 months

    The National Cancer Institute's Family Life, Activity, Sun, Health, and Eating (FLASHE) dietary screener self reported questionnaire s 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

  4. Weight

    Time frame: Baseline, 6 months, 12 months

    Staff-assessed using Tanita scale

  5. Liver steatosis and/or stiffness

    Time frame: Baseline, 6 months, 12 months

    Liver steatosis and/or stiffness as assessed by FibroScan and/or potential steatosis as assessed by liver enzymes using Piccolo Xpress chemistry analyzer

  6. Fasting glucose levels

    Time frame: Baseline, 6 months, 12 months

    As assessed using Piccolo Xpress chemistry analyzer

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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