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

NCT ID: NCT07199491

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-10-31

Brief Summary

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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

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Conditions

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Metabolic-dysfunction Associated Liver Disease (MASLD)

Keywords

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weight loss alcohol consumption Diabetes Prevention Program (DPP)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Healthy Liver/Hígado Sano program

Group Type EXPERIMENTAL

Healthy Liver/Hígado Sano program

Intervention Type BEHAVIORAL

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 Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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Healthy Liver/Hígado Sano program

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.

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Natalia Heredia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natalia Heredia

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Natalia Heredia

Role: CONTACT

Phone: (713) 500 9600

Email: [email protected]

Facility Contacts

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Natalia Heredia

Role: primary

Other Identifiers

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K01MD019149

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-SPH-25-0539

Identifier Type: -

Identifier Source: org_study_id