NCT06854185

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2025-02-05
• Primary completion: 2026-02-05
• Completion: 2026-12-31
• First posted: 2025-03-03
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States