Healthy Lifestyle Program for Fatty Liver Disease

NH
Overseen ByNatalia Heredia
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a lifestyle program called the Healthy Liver/Hígado Sano can aid Hispanic/Latino individuals with non-alcoholic fatty liver disease in losing weight and improving liver function. Participants will either follow this new program or continue with their usual care to determine which is more effective. Eligible participants should be Hispanic/Latino, diagnosed with this liver condition, and have a family member who can attend all sessions. They must also have internet access and be able to speak English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance health outcomes for the Hispanic/Latino community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Healthy Liver/Hígado Sano program is safe for improving liver health?

A previous study showed that programs like Healthy Liver/Hígado Sano are safe for participants. These programs help people improve their diet and increase physical activity, which most handle well. No reports of serious side effects have emerged from joining these programs. Participants might experience temporary soreness or tiredness from increased activity, but these effects are usually mild and manageable. Overall, the Healthy Liver/Hígado Sano program is considered safe for those aiming to improve liver health and lose weight.12345

Why are researchers excited about this trial?

Researchers are excited about the Healthy Liver/Hígado Sano program because it offers a fresh approach to managing fatty liver disease through lifestyle modifications rather than medication or surgery. Unlike standard treatments, which often involve drugs like vitamin E or pioglitazone, this program emphasizes a holistic lifestyle change, focusing on diet, exercise, and behavioral support to improve liver health. By empowering patients to make sustainable changes, this program could potentially reduce liver fat and inflammation naturally, providing a non-invasive alternative that aligns with overall wellness goals.

What evidence suggests that the Healthy Liver/Hígado Sano program might be an effective treatment for fatty liver disease?

Research has shown that lifestyle changes can improve liver health in people with metabolic dysfunction associated steatotic liver disease (MASLD), also known as non-alcoholic fatty liver disease (NAFLD). In this trial, participants will either follow the Healthy Liver/Hígado Sano program, a lifestyle change plan designed for Hispanic/Latino patients, or receive usual care. Early studies suggest that programs like the Healthy Liver/Hígado Sano program can help reduce liver fat by promoting healthy eating and exercise. For instance, following a Mediterranean diet, which includes healthy fats, has decreased liver fat. These findings offer hope that the Healthy Liver/Hígado Sano program may help patients lose weight and improve their liver health.678910

Who Is on the Research Team?

NH

Natalia Heredia

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latino patients with metabolic dysfunction associated steatotic liver disease (MASLD), also known as non-alcoholic fatty liver disease (NAFLD). Participants should be interested in weight loss and improving liver health. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Self-reported Hispanic/Latino
Have access to internet, either on their phone, at home or at some other location convenient to the participant
I have been diagnosed with MASLD.
See 2 more

Exclusion Criteria

I do not have a working phone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Healthy Liver/Hígado Sano program, a behavioral lifestyle intervention aimed at improving liver health and promoting weight loss

6 months
Regular visits as per program schedule

Follow-up

Participants are monitored for changes in physical activity and diet, as well as overall satisfaction with the intervention

6 months
Follow-up assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Healthy Liver/Hígado Sano program
Trial Overview The study tests the Healthy Liver/Hígado Sano program, a behavioral lifestyle intervention aimed at helping participants lose weight and improve liver health, against usual care practices for managing MASLD/NAFLD.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Liver/Hígado Sano programExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40786161/
Adaptation using IM Adapt of an evidence-based lifestyle ...This resulted in the proposed Healthy Liver/Hígado Sano program. ... liver disease; non-alcoholic fatty liver disease. Copyright © 2025 ...
CHPPR Study Pilot Testing a Culturally Tailored ...The Healthy Liver/Hígado Sano Study is pilot testing a behavioral lifestyle intervention for Hispanic adults with non-alcoholic fatty liver disease (NAFLD).
Adaptation using IM Adapt of an evidence-based lifestyle ...Non-alcoholic fatty liver disease (NAFLD), now called metabolic-dysfunction associated steatotic liver disease (MASLD) (1), is one of the most common causes ...
Different Dietary Approaches, Non-Alcoholic Fatty Liver ...Non-alcoholic fatty liver disease (NAFLD) is the first cause of chronic liver disease. ... fat, the Mediterranean diet is recognized as a healthy ...
Effect of a low glycemic index Mediterranean diet on non- ...Hussein O, Grosovski M, Lasri E, et al. Monounsaturated fat decreases hepatic lipid content in non-alcoholic fatty liver disease in rats. World J Gastroenterol, ...
Evidence From a Systematic Review of Non-alcoholic Fatty ...CVD: Cardiovascular Disease; NAFLD: Non-alcoholic Fatty Liver Disease ... Hepatic steatosis and cardiovascular disease outcomes: an ...
Nonalcoholic Fatty Liver Disease (NAFLD)Nonalcoholic Fatty Liver Disease is the build-up of extra fat in liver cells not caused by alcohol. The severe form is called nonalcoholic ...
Nonalcoholic fatty liver disease - Survival ratesAnalysis of a simulation model to estimate long-term outcomes in patients with nonalcoholic fatty liver disease. JAMA Network Open. 2022 ...
Understanding the Burden of Nonalcoholic Fatty Liver DiseaseThese states contribute to ectopic fat accumulation, worsening of IR, lipotoxicity, impaired β-cell function, and excess free fatty acids (FFAs) ...
Prospective Study of Outcomes in Adults with Nonalcoholic ...The true rates and types of clinical outcomes among persons with nonalcoholic fatty liver or NASH with varying grades of disease activity and ...
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