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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metabolic Syndrome; Overweight (BMI > 25); Metabolic Dysfunction Associated Steatotic Liver Disease
• Intervention / Treatment: Behavioral: Paso Program

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Harris Health - Smith

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.; Other Names: Paso a Paso: Rumbo a Un Higado Sano; Step by Step: Journey to a Healthy Liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasbility	Average attendance > 8 sessions across participants	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in absolute weight	Average absolute weight change (kg)	baseline to 6 months
change in muscle strength	Average change, measured by hand grip dynamometry	baseline to 6 months
change in liver stiffness	Average Change in liver stiffness values assessed by transient elastography	baseline to 6 months
change in liver CAP	Average change in continued attenuation parameter assessed by transient elastography	baseline to 6 months
change in liver enzymes	Average change in transaminases	baseline to 6 months
change in hemoglobin A1C	Average change in hemoglobin a1c	baseline to 6 months
change in diet quality	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.	baseline to 6 months
change in daily calorie intake	change in average daily calorie intake assessed by DHQIII	baseline to 6 months
change in fat intake	Change in average fat intake assessed by DHQIII	baseline to 6 months
change in alcohol intake	Change in alcohol intake, assessed by AUDIT-C	baseline to 6 months
change in average weekly minutes of moderate-to-vigorous physical activity	Change in average time spent doing moderate to vigorous physical activity every week assessed by actigraphy	baseline to 6 months
change in average daily steps	change in average daily steps assessed by actigraphy	baseline to 6 months
Change in perceived treatment efficacy	Change in average composite score, treatment efficacy questionnaire	baseline to 6 months
Change in dietary self-efficacy	Change in dietary self-efficacy assessed using Schwarzer & Renner scale	baseline to 6 months
Change in physical activity self-efficacy	Change in physical activity self-efficacy assessed using Schwarzer & Renner scale	baseline to 6 months
Change in social support for diet	Change in diet social support assessed using Sallis perceived social support scale	baseline to 6 months
Change in social support for physical activity	Change in physical activity social support assessed using Sallis perceived social support scale	baseline to 6 months
Change in perceived stress	assessed by perceived stress scale	baseline to 6 months
change in % weight	average % change in weight	baseline to 1 year
change in absolute weight	Average absolute weight change (kg)	baseline to 1 year
change in muscle strength	Average change, measured by hand grip dynamometry	baseline to 1 year
change in liver stiffness and CAP	Average change in liver stiffness and continued attenuation parameter assessed by transient elastography	baseline to 1 year
change in liver enzymes	Average change in transaminases	baseline to 1 year
change in lipids	Average change in lipids	baseline to 1 year
change in physical activity level	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.	baseline to 1 year
change in physical activity level	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.	baseline to 6months
Change in dietary self-efficacy	Change in dietary self-efficacy assessed using Schwarzer & Renner scale	baseline to 1 year
Change in physical activity self-efficacy	Change in physical activity self-efficacy assessed using Schwarzer & Renner scale	baseline to 1 year
Change in social support for diet	Change in diet social support assessed using Sallis perceived social support scale	baseline to 1 year
Change in social support for physical activity	Change in physical activity social support assessed using Sallis perceived social support scale	baseline to 1 year
change in average weekly minutes of moderate-to-vigorous physical activity	Change in average time spent doing moderate to vigorous physical activity every week assessed by actigraphy	baseline to 1 year
change in percent weight	average percent change in weight	baseline to 6 months
change in quality of life	change in quality of life assessed by a questionnaire called "Patient-Reported Outcomes Measurement Information System - Global score"	baseline to 6 months
Change in perception of metabolic dysfunction associated steatotic liver disease	Change in average composite score, Illness perception questionnaire	baseline to 6 months

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Maya Balakrishnan, Baylor College of Medicine

Publications and helpful links

Helpful Links

• This website provide a description of the Paso program. It also gives study participants electronic access to session materials and meal plans.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Actual): February 5, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: weight loss; metabolic syndrome; behavior change; overweight/obesity; metabolic dysfunction associated steatotic liver disease; adapted weight loss intervention; intervention feasibility
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss; Metabolic Syndrome
• Other Study ID Numbers: H-55723; K23MD016955 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study's primary purpose is to test the feasibility of the Paso program in this pilot single arm study. Therefore, IPD sharing is not planned at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No