Clinical trial NCT06854185: Feasibility of the Paso Program for Patients With Metabolic Dysfunction Associated Steatotic Liver Disease
Official title: Feasibility of the "Paso a Paso" Weight Loss Program for Mexican & Central American Patients With Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Dysfunction Associated Steatotic Liver Disease
Overweight (BMI &gt; 25)
Metabolic Syndrome
Keywords: metabolic dysfunction associated steatotic liver disease
adapted weight loss intervention
weight loss
intervention feasibility
behavior change
metabolic syndrome
overweight/obesity
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm trial testing the feasibility of the behavioral weight loss program. All study participants will receive the intervention.
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Feasbility
timeFrame: 6 months
Secondary outcomes:
measure: change in percent weight
timeFrame: baseline to 6 months
measure: change in absolute weight
timeFrame: baseline to 6 months
measure: change in muscle strength
timeFrame: baseline to 6 months
measure: change in liver stiffness
timeFrame: baseline to 6 months
measure: change in liver CAP
timeFrame: baseline to 6 months
measure: change in liver enzymes
timeFrame: baseline to 6 months
measure: change in hemoglobin A1C
timeFrame: baseline to 6 months
measure: change in diet quality
timeFrame: baseline to 6 months
measure: change in daily calorie intake
timeFrame: baseline to 6 months
measure: change in fat intake
timeFrame: baseline to 6 months
measure: change in alcohol intake
timeFrame: baseline to 6 months
measure: change in average weekly minutes of moderate-to-vigorous physical activity
timeFrame: baseline to 6 months
measure: change in average daily steps
timeFrame: baseline to 6 months
measure: change in quality of life
timeFrame: baseline to 6 months
measure: Change in perception of metabolic dysfunction associated steatotic liver disease
timeFrame: baseline to 6 months
measure: Change in perceived treatment efficacy
timeFrame: baseline to 6 months
measure: Change in dietary self-efficacy
timeFrame: baseline to 6 months
measure: Change in physical activity self-efficacy
timeFrame: baseline to 6 months
measure: Change in social support for diet
timeFrame: baseline to 6 months
measure: Change in social support for physical activity
timeFrame: baseline to 6 months
measure: Change in perceived stress
timeFrame: baseline to 6 months
measure: change in % weight
timeFrame: baseline to 1 year
measure: change in absolute weight
timeFrame: baseline to 1 year
measure: change in muscle strength
timeFrame: baseline to 1 year
measure: change in liver stiffness and CAP
timeFrame: baseline to 1 year
measure: change in liver enzymes
timeFrame: baseline to 1 year
measure: change in lipids
timeFrame: baseline to 1 year
measure: change in physical activity level
timeFrame: baseline to 1 year
measure: change in physical activity level
timeFrame: baseline to 6months
measure: Change in dietary self-efficacy
timeFrame: baseline to 1 year
measure: Change in physical activity self-efficacy
timeFrame: baseline to 1 year
measure: Change in social support for diet
timeFrame: baseline to 1 year
measure: Change in social support for physical activity
timeFrame: baseline to 1 year
measure: change in average weekly minutes of moderate-to-vigorous physical activity
timeFrame: baseline to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Harris Health - Smith
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Maya Balakrishnan
role: PRINCIPAL_INVESTIGATOR
References: