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

NCT ID: NCT06854185

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2026-12-31

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.

Detailed Description

Weight loss is an important part of treating fatty liver disease. The investigators have developed a weight loss program for Mexican and Central American patients with fatty liver disease (also known as Metabolic Dysfunction Associated Steatotic Liver Disease). The name of the weight loss program is "Paso a Paso: Rumbo a Un Higado Sano" / "Step by Step: Journey to a Healthy Liver."

The purpose of this study is to learn whether the Paso weight loss program is acceptable to patients and feasible to participate in.

Participants who join the study will participate in a 6 month weight loss program, consisting of 16 1-hour group counseling classes that teach about healthy eating, physical activity, and behavioral strategies to break old habits and create new ones. Participants are required to attend 4 classes in person, and the remainder can be attended in person or virtually.

The program classes are offered at 5 locations across Houston. Participants can choose the location most convenient, and are then assigned to that location, along with other participants who also choose that location, for the duration of the program.

Study participants will be asked to complete questionnaires and testing for the study at 4 time points over 1 year: before starting the program, in the middle of the program, at the end of the program, and 6 months after the program ends. All questionnaires and testing are done during regular clinic visits, during program sessions, or over the phone. The testing includes questionnaires, measurement of your weight and muscle strength, and an optional fibroscan (ultrasound) of the liver. In addition, data about medical history and blood testing will be recorded from participants' medical records.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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

Group Type: EXPERIMENTAL

Paso Program

Intervention Type: 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.

Interventions

Paso Program

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Paso a Paso: Rumbo a Un Higado Sano; Step by Step: Journey to a Healthy Liver

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Maya Balakrishnan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maya Balakrishnan

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Harris Health - Smith

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: IRB protocol report

View Document

Document Type: Study Protocol: Full protocol

View Document

Document Type: Informed Consent Form: English Consent Form

View Document

Related Links

https://www.bcm.edu/paso-a-paso-higado-sano

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

Other Identifiers

K23MD016955

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-55723

Identifier Type: -

Identifier Source: org_study_id