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

Baylor College of Medicine

Status: Active, not recruiting

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

Treatments: Behavioral: Paso Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06854185

K23MD016955 (U.S. NIH Grant/Contract)

H-55723

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intervention Arm

Experimental group

Description:

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

Treatment:

Behavioral: Paso Program