Feasibility of the Paso Program for Patients With Metabolic Dysfunction Associated Steatotic Liver Disease

NCT06854185 | Active Not Recruiting

• 2 other identifiers: H-55723K23MD016955
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn whether the Paso weight loss program is feasible for Mexican and Central American patients with fatty liver disease. In addition, the investigators will also look at whether the program improves weight loss, fatty liver disease, physical activity, diet, and family support among patients.

Conditions

Metabolic Syndrome; Overweight (BMI > 25); Metabolic Dysfunction Associated Steatotic Liver Disease

Keywords

metabolic dysfunction associated steatotic liver disease; adapted weight loss intervention; weight loss; intervention feasibility; behavior change; metabolic syndrome; overweight/obesity

Outcome Measures

Primary Outcomes (1)

• Feasbility

  Average attendance \> 8 sessions across participants

  6 months

Secondary Outcomes (34)

• change in percent weight

  baseline to 6 months

• change in absolute weight

  baseline to 6 months

• change in muscle strength

  baseline to 6 months

• change in liver stiffness

  baseline to 6 months

• change in liver CAP

  baseline to 6 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

All participants will receive the intervention, which is a behavioral weight loss program called "Paso a Paso: Rumbo a Un Higado Sano" ("Paso Program").

Behavioral: Paso Program

Interventions

Paso Program BEHAVIORAL

The Paso Program is a behavioral weight loss program. It consists of a series of 16 one-hour-long semi-structured group counseling sessions led by a health educator every 1-2 weeks over 26 weeks. Each session has a curriculum with a counselor's guide and patient facing materials, covers specific topics (eating, physical activity, behavioral change strategies). Teaching methods include discussions, practice activities, demonstrations. The program is delivered to groups of 8 to 14 participants, classes are offered primarily in-person with the option of virtual attendance.

Also known as: Paso a Paso: Rumbo a Un Higado Sano, Step by Step: Journey to a Healthy Liver

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with MASLD (defined per guideline based diagnostic criteria: evidence of steatosis with at least 1 metabolic syndrome feature)
• Self-reported Mexican or Central American ethnicity
• Age between 18 and 70 years
• BMI≥25kg/m2
• Able to read and write English and/or Spanish

You may not qualify if:

• ≥5% weight loss over the prior 3 months
• HbA1c ≥9.0% within 30 days of weight loss program initiation\*
• History of bariatric surgery
• 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,
• Any history of liver disease decompensations\*\* or hepatocellular carcinoma,
• History of any organ transplant (including liver transplant)
• 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.
• Ongoing heavy alcohol use defined as 320-420grams/week
• 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)\*
• Pioglitazone is allowed if on a stable dose for 3 months prior to study entry
• current pregnancy/nursing or planned pregnancy
• conditions limiting dietary calorie reduction or physical activity
• 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)
• unstable cardiac disease

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Baylor College of Medicine: lead

Study Sites (1)

Harris Health - Smith

Houston, Texas, 77030, United States

Location

Related Links

• This website provide a description of the Paso program. It also gives study participants electronic access to session materials and meal plans.

MeSH Terms

Conditions

Overweight; Metabolic Syndrome; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Study Officials

• Maya Balakrishnan

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single arm trial testing the feasibility of the behavioral weight loss program. All study participants will receive the intervention.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 3, 2025
• Study Start: February 5, 2025
• Primary Completion: February 5, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)