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

N/AActive Not RecruitingNCT06854185

Baylor College of Medicine50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

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

Interventions

Paso ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Harris Health - Smith

Houston, Texas, United States

Outcomes

Primary Outcomes

Feasbility

Average attendance \> 8 sessions across participants

Time frame: 6 months