ACTIVE_NOT_RECRUITING

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

Conditions

Metabolic Dysfunction Associated Steatotic Liver Disease Overweight (BMI > 25)Metabolic Syndrome adapted weight loss intervention weight loss intervention feasibility behavior change overweight/obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility of the "Paso a Paso" Weight Loss Program for Mexican & Central American Patients With Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD)

Quick Facts

Study Start:2025-02-05

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06854185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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: 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)

Inclusion Criteria

Exclusion 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

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:
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)

Contacts and Locations

Principal Investigator

Maya Balakrishnan

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Harris Health - Smith

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Maya Balakrishnan, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-05

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-02-05

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

metabolic dysfunction associated steatotic liver disease
adapted weight loss intervention
weight loss
intervention feasibility
behavior change
metabolic syndrome
overweight/obesity

Additional Relevant MeSH Terms

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