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Metabolic-dysfunction Associated Liver Disease (MASLD)NCT07199491

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

A study testing Healthy Liver/Hígado Sano program in people with Metabolic-dysfunction Associated Liver Disease (MASLD), run by The University of Texas Health Science Center, Houston at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Healthy Liver/Hígado Sano program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
29 Jan 2026to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

Official 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

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

Read the detailed description

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.

Being tested
Healthy Liver/Hígado Sano program, Usual Care
Keywords
weight loss, alcohol consumption, Diabetes Prevention Program (DPP)
Medical subject headings
Weight Loss, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Liver/Hígado Sano programBehavioural

    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 CareBehavioural

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

Study groups in NCT07199491
Study groupRoleWhat they receive
Healthy Liver/Hígado Sano programExperimentalNot described
Receives: Behavioral: Healthy Liver/Hígado Sano program
Usual CareActive comparatorNot described
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Feasibility

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

    Measured: Baseline

  2. Retention

    Percent of participants who complete follow-up data collection

    Measured: 6 months, 12 months

  3. Adherence

    Intervention participants who attend education sessions

    Measured: 6 months

  4. 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.

    Measured: 6 months

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, 6 months, 12 months

  2. Accelerometer-assessed physical activity

    As assessed by the Actigraph GT9X accelerometers

    Measured: Baseline, 6 months, 12 months

  3. Diet

    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

    Measured: Baseline, 6 months, 12 months

  4. Weight

    Staff-assessed using Tanita scale

    Measured: Baseline, 6 months, 12 months

  5. Liver steatosis and/or stiffness

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

    Measured: Baseline, 6 months, 12 months

  6. Fasting glucose levels

    As assessed using Piccolo Xpress chemistry analyzer

    Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start29 Jan 2026
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07199491
Sponsor's protocol ID
HSC-SPH-25-0539
Other IDs
K01MD019149
Status last verified
Feb 2026
First submitted
21 Sep 2025
Last updated
3 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Liver/Hígado Sano program in people with Metabolic-dysfunction Associated Liver Disease (MASLD), run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Feasibility (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07199491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

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