Testing a Multilevel, Culturally Appropriate Lifestyle Intervention For Hispanic Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healthy Liver/Hígado Sano program, Usual Care.
- Who it may be relevant to
- Registry conditions: Metabolic-dysfunction Associated Liver Disease (MASLD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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
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.
Interventions
- Behavioral Healthy Liver/Hígado Sano program
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 appropria - Behavioral Usual Care
Observational clinic participants receive usual care, which can include referrals to dieticians and/or specialists.
Primary outcome measures
- Recruitment Feasibility [Time frame: Baseline]
- Retention [Time frame: 6 months, 12 months]
- Adherence [Time frame: 6 months]
- Participant satisfaction [Time frame: 6 months]
Secondary outcome measures (6)
- Self-reported Physical Activity [Time frame: Baseline, 6 months, 12 months]
- Accelerometer-assessed physical activity [Time frame: Baseline, 6 months, 12 months]
- Diet [Time frame: Baseline, 6 months, 12 months]
- Weight [Time frame: Baseline, 6 months, 12 months]
- Liver steatosis and/or stiffness [Time frame: Baseline, 6 months, 12 months]
- Fasting glucose levels [Time frame: Baseline, 6 months, 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT07199491 · HSC-SPH-25-0539 · K01MD019149