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Can a Step-by-Step program help latinos beat fatty liver?

NCT ID NCT06854185

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a 26-week behavioral weight loss program called 'Paso a Paso' is practical for Mexican and Central American adults with fatty liver disease and overweight. Researchers will track attendance, weight loss, liver stiffness, and diet changes in 50 participants. The goal is to see if this culturally tailored program can help manage the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paso a Paso behavioral weight loss program
What this could lead to
If successful, this program could offer a practical, culturally tailored way to help people with fatty liver disease lose weight and improve liver health.
What could go wrong
This is a small feasibility study with only 50 participants and no control group, so results may not apply broadly. The program requires active participation and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosed with MASLD (defined per guideline based diagnostic criteria: evidence of steatosis with at least 1 metabolic syndrome feature) 2. Self-reported Mexican or Central American ethnicity 3. Age between 18 and 70 years 4. BMI≥25kg/m2 5. Able to read and write English and/or Spanish Exclusion Criteria: 1. ≥5% weight loss over the prior 3 months 2. HbA1c ≥9.0% within 30 days of weight loss program initiation\* 3. History of bariatric surgery 4. Advanced liver disease, defined as: platelet count \< 150,000, serum albumin \<3.5 g/dL, except as explained by non-hepatic causes. INR \>1.4 unless due to therapeutic anticoagulants or laboratory error. Total bilirubin ≥2 mg/dL (unless explained by Gilbert Syndrome). Presence of esophageal varices, 5. Any history of liver disease decompensations\*\* or hepatocellular carcinoma, 6. History of any organ transplant (including liver transplant) 7. Active HCV infection (defined as HCV Ab positive with detectable viral load)\*, Hepatitis B infection (defined as positive HBsAg) and/or other etiologies of chronic liver disease (AIH, PBC, Wilson disease, PSC) or acute hepatic injury. 8. Ongoing heavy alcohol use defined as 320-420grams/week 9. SGLT2 inhibitor or Glucagon-like peptide 1 (GLP-1) agonist therapy for diabetes treatment (e.g., exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide, and albiglutide) or for weight loss (e.g., semaglutide at doses up to 2.4 mg subcutaneous weekly) must be at a stable dose for at least 6 months prior to study entry with stable weight (defined as \<5% weight loss in the 12 weeks prior to study entry)\* 10. Pioglitazone is allowed if on a stable dose for 3 months prior to study entry 11. current pregnancy/nursing or planned pregnancy 12. conditions limiting dietary calorie reduction or physical activity 13. Active cancer, except for example non-melanoma skin cancers or cancers that have clearly been cured, stable and being monitored by primary doctor or oncologist without active treatment, or carries an excellent prognosis (e.g., Stage 1 cervical cancer) 14. unstable cardiac disease 15. intestinal resection or malabsorption disorders 16. life expectancy\<2 years 17. competing serious medical or psychiatric comorbidity 18. HIV infection 19. History of noncompliance (\>3 primary care, endocrine, and/or hepatology clinic no-shows in the past year)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Harris Health - Smith

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.