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

Not Applicable

Recruiting

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

• Registration Number: NCT06854185
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study Start: 2025-02-05
• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-25
• Status Verified: 2025-03
• Study First Posted: 2025-03-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-02-05
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasbility	6 months	Average attendance \> 8 sessions across participants

Secondary Outcome Measures

Name	Time	Method
change in percent weight	baseline to 6 months	average percent change in weight
change in absolute weight	baseline to 1 year	Average absolute weight change (kg)
change in muscle strength	baseline to 1 year	Average change, measured by hand grip dynamometry
change in liver stiffness	baseline to 6 months	Average Change in liver stiffness values assessed by transient elastography
change in liver CAP	baseline to 6 months	Average change in continued attenuation parameter assessed by transient elastography
change in liver enzymes	baseline to 1 year	Average change in transaminases
change in hemoglobin A1C	baseline to 6 months	Average change in hemoglobin a1c
change in diet quality	baseline to 6 months	Average change in Healthy Eating Index assessed by diet history questionnaire III. The Healthy eating score ranges from 0 to 100. A higher number means a healthier diet quality.
change in daily calorie intake	baseline to 6 months	change in average daily calorie intake assessed by DHQIII
change in fat intake	baseline to 6 months	Change in average fat intake assessed by DHQIII
change in alcohol intake	baseline to 6 months	Change in alcohol intake, assessed by AUDIT-C
change in average weekly minutes of moderate-to-vigorous physical activity	baseline to 1 year	Change in average time spent doing moderate to vigorous physical activity every week assessed by actigraphy
change in average daily steps	baseline to 6 months	change in average daily steps assessed by actigraphy
change in quality of life	baseline to 6 months	change in quality of life assessed by a questionnaire called "Patient-Reported Outcomes Measurement Information System - Global score"
Change in perception of metabolic dysfunction associated steatotic liver disease	baseline to 6 months	Change in average composite score, Illness perception questionnaire
Change in perceived treatment efficacy	baseline to 6 months	Change in average composite score, treatment efficacy questionnaire
Change in dietary self-efficacy	baseline to 1 year	Change in dietary self-efficacy assessed using Schwarzer \& Renner scale
Change in physical activity self-efficacy	baseline to 1 year	Change in physical activity self-efficacy assessed using Schwarzer \& Renner scale
Change in social support for diet	baseline to 1 year	Change in diet social support assessed using Sallis perceived social support scale
Change in social support for physical activity	baseline to 1 year	Change in physical activity social support assessed using Sallis perceived social support scale
Change in perceived stress	baseline to 6 months	assessed by perceived stress scale
change in % weight	baseline to 1 year	average % change in weight
change in liver stiffness and CAP	baseline to 1 year	Average change in liver stiffness and continued attenuation parameter assessed by transient elastography
change in lipids	baseline to 1 year	Average change in lipids
change in physical activity level	baseline to 6months	Change in physical activity category assessed by the International Physical Activity Questionnaire. This questionnaire estimates the estimated resting energy expenditure and can categorize people's physical activity level as low, moderate, or high.

Trial Locations

Locations (1)

Harris Health - Smith; 🇺🇸 Houston, Texas, United States