Weight loss program for patients with fatty liver disease

Feasibility of the "Paso a Paso" Weight Loss Program for Mexican & Central American Patients With Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD)

This study is testing a weight loss program designed for Mexican and Central American patients with fatty liver disease to see if it helps them lose weight and improve their health over six months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Baylor College of Medicine (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06854185 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of the Paso weight loss program specifically designed for Mexican and Central American patients with Metabolic Dysfunction Associated Steatotic Liver Disease. Participants will engage in a 6-month program that includes 16 group counseling sessions focused on healthy eating, physical activity, and behavioral changes. The program allows for a combination of in-person and virtual attendance, making it accessible to a wider audience. Participants will be assessed at four different time points over the course of a year to measure the program's impact on weight loss and overall health.

Who should consider this trial

Good fit: Ideal candidates are Mexican or Central American adults aged 18 to 70 with a BMI of 25 or higher and diagnosed with fatty liver disease.

Not a fit: Patients who have experienced significant weight loss recently, have advanced liver disease, or have a history of bariatric surgery may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could lead to significant improvements in weight management and liver health for patients with fatty liver disease.

How similar studies have performed: Other studies have shown positive outcomes with similar weight loss interventions for patients with metabolic conditions, suggesting potential success for this approach.

Eligibility criteria

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)

Where this trial is running

Houston, Texas

• Harris Health - Smith — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Maya Balakrishnan — Baylor College of Medicine
• Study coordinator: Maya Balakrishnan, MD MPH

Conditions Metabolic Dysfunction Associated Steatotic Liver Disease; Overweight (BMI > 25); Metabolic Syndrome; metabolic dysfunction associated steatotic liver disease; adapted weight loss intervention; weight loss; intervention feasibility