Metabolic Dysfunction Associated Steatotic Liver DiseaseNCT06854185
Feasibility of the Paso Program for Patients With Metabolic Dysfunction Associated Steatotic Liver Disease
A study testing Paso Program in people with Metabolic Dysfunction Associated Steatotic Liver Disease and Overweight (BMI > 25), run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Dysfunction Associated Steatotic Liver Disease, Overweight (BMI > 25), Metabolic Syndrome
- What is being tested?
- Paso Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with MASLD (defined per guideline based diagnostic criteria: evidence of steatosis with at least 1 metabolic syndrome feature)
- Self-reported Mexican or Central American ethnicity
- Age between 18 and 70 years
- BMI≥25kg/m2
- Able to read and write English and/or Spanish
Who cannot join
- ≥5% weight loss over the prior 3 months
- HbA1c ≥9.0% within 30 days of weight loss program initiation*
- History of bariatric surgery
- 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,
- Any history of liver disease decompensations** or hepatocellular carcinoma,
Show all 20Show fewer
- History of any organ transplant (including liver transplant)
- 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.
- Ongoing heavy alcohol use defined as 320-420grams/week
- 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)*
- Pioglitazone is allowed if on a stable dose for 3 months prior to study entry
- current pregnancy/nursing or planned pregnancy
- conditions limiting dietary calorie reduction or physical activity
- 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)
- unstable cardiac disease
- intestinal resection or malabsorption disorders
- life expectancy<2 years
- competing serious medical or psychiatric comorbidity
- HIV infection
- History of noncompliance (>3 primary care, endocrine, and/or hepatology clinic no-shows in the past year)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Dysfunction Associated Steatotic Liver Disease, Overweight (BMI > 25), Metabolic Syndrome
- Being tested
- Paso Program
- Keywords
- metabolic dysfunction associated steatotic liver disease, adapted weight loss intervention, weight loss, intervention feasibility, behavior change, metabolic syndrome, overweight/obesity
- Medical subject headings
- Overweight, Metabolic Syndrome, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paso ProgramBehavioural
Also called Paso a Paso: Rumbo a Un Higado Sano, Step by Step: Journey to a Healthy Liver
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | All participants will receive the intervention, which is a behavioral weight loss program called "Paso a Paso: Rumbo a Un Higado Sano" ("Paso Program"). Receives: Behavioral: Paso Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasbility
Average attendance > 8 sessions across participants
Measured: 6 months
Secondary outcomes (34)
change in percent weight
average percent change in weight
Measured: baseline to 6 months
change in absolute weight
Average absolute weight change (kg)
Measured: baseline to 6 months
change in muscle strength
Average change, measured by hand grip dynamometry
Measured: baseline to 6 months
change in liver stiffness
Average Change in liver stiffness values assessed by transient elastography
Measured: baseline to 6 months
change in liver CAP
Average change in continued attenuation parameter assessed by transient elastography
Measured: baseline to 6 months
change in liver enzymes
Average change in transaminases
Measured: baseline to 6 months
change in hemoglobin A1C
Average change in hemoglobin a1c
Measured: 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.
Measured: baseline to 6 months
change in daily calorie intake
change in average daily calorie intake assessed by DHQIII
Measured: baseline to 6 months
change in fat intake
Change in average fat intake assessed by DHQIII
Measured: baseline to 6 months
change in alcohol intake
Change in alcohol intake, assessed by AUDIT-C
Measured: 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
Measured: baseline to 6 months
change in average daily steps
change in average daily steps assessed by actigraphy
Measured: 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"
Measured: baseline to 6 months
Change in perception of metabolic dysfunction associated steatotic liver disease
Change in average composite score, Illness perception questionnaire
Measured: baseline to 6 months
Change in perceived treatment efficacy
Change in average composite score, treatment efficacy questionnaire
Measured: baseline to 6 months
Change in dietary self-efficacy
Change in dietary self-efficacy assessed using Schwarzer \& Renner scale
Measured: baseline to 6 months
Change in physical activity self-efficacy
Change in physical activity self-efficacy assessed using Schwarzer \& Renner scale
Measured: baseline to 6 months
Change in social support for diet
Change in diet social support assessed using Sallis perceived social support scale
Measured: baseline to 6 months
Change in social support for physical activity
Change in physical activity social support assessed using Sallis perceived social support scale
Measured: baseline to 6 months
Change in perceived stress
assessed by perceived stress scale
Measured: baseline to 6 months
change in % weight
average % change in weight
Measured: baseline to 1 year
change in absolute weight
Average absolute weight change (kg)
Measured: baseline to 1 year
change in muscle strength
Average change, measured by hand grip dynamometry
Measured: baseline to 1 year
change in liver stiffness and CAP
Average change in liver stiffness and continued attenuation parameter assessed by transient elastography
Measured: baseline to 1 year
change in liver enzymes
Average change in transaminases
Measured: baseline to 1 year
change in lipids
Average change in lipids
Measured: 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.
Measured: 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.
Measured: baseline to 6months
Change in dietary self-efficacy
Change in dietary self-efficacy assessed using Schwarzer \& Renner scale
Measured: baseline to 1 year
Change in physical activity self-efficacy
Change in physical activity self-efficacy assessed using Schwarzer \& Renner scale
Measured: baseline to 1 year
Change in social support for diet
Change in diet social support assessed using Sallis perceived social support scale
Measured: baseline to 1 year
Change in social support for physical activity
Change in physical activity social support assessed using Sallis perceived social support scale
Measured: 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
Measured: baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start5 Feb 2025
- Primary completion5 Feb 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm trial testing the feasibility of the behavioral weight loss program. All study participants will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Maya Balakrishnan, Baylor College of Medicine
- Investigators
- Maya Balakrishnan, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854185
- Sponsor's protocol ID
- H-55723
- Other IDs
- K23MD016955
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the "Paso a Paso" Weight Loss Program for Mexican & Central American Patients With Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD)
- ClinicalTrials.gov ID
- NCT06854185
- Acronym / sponsor ID
- H-55723
- Conditions
- Metabolic Dysfunction Associated Steatotic Liver Disease, Overweight (BMI > 25), Metabolic Syndrome
- Keywords
- metabolic dysfunction associated steatotic liver disease, adapted weight loss intervention, weight loss, intervention feasibility, behavior change, metabolic syndrome, overweight/obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm trial testing the feasibility of the behavioral weight loss program. All study participants will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Paso ProgramAll participants will receive the intervention, which is a behavioral weight loss program called "Paso a Paso: Rumbo a Un Higado Sano" ("Paso Program"). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with MASLD (defined per guideline based diagnostic criteria: evidence of steatosis with at least 1 metabolic syndrome feature)
- Self-reported Mexican or Central American ethnicity
- Age between 18 and 70 years
- BMI≥25kg/m2
- Able to read and write English and/or Spanish
Key exclusion criteria (20 listed)
- ≥5% weight loss over the prior 3 months
- HbA1c ≥9.0% within 30 days of weight loss program initiation*
- History of bariatric surgery
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paso ProgramAlso: Paso a Paso: Rumbo a Un Higado Sano, Step by Step: Journey to a Healthy LiverThe 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. | Behavioural | Intervention Arm |
Primary outcome
Feasbility
Time frame: 6 months
Average attendance > 8 sessions across participants
34 secondary outcomes
change in percent weight
Time frame: baseline to 6 months
change in absolute weight
Time frame: baseline to 6 months
change in muscle strength
Time frame: baseline to 6 months
change in liver stiffness
Time frame: baseline to 6 months
change in liver CAP
Time frame: baseline to 6 months
change in liver enzymes
Time frame: baseline to 6 months
change in hemoglobin A1C
Time frame: baseline to 6 months
change in diet quality
Time frame: baseline to 6 months
change in daily calorie intake
Time frame: baseline to 6 months
change in fat intake
Time frame: baseline to 6 months
change in alcohol intake
Time frame: baseline to 6 months
change in average weekly minutes of moderate-to-vigorous physical activity
Time frame: baseline to 6 months
change in average daily steps
Time frame: baseline to 6 months
change in quality of life
Time frame: baseline to 6 months
Change in perception of metabolic dysfunction associated steatotic liver disease
Time frame: baseline to 6 months
Change in perceived treatment efficacy
Time frame: baseline to 6 months
Change in dietary self-efficacy
Time frame: baseline to 6 months
Change in physical activity self-efficacy
Time frame: baseline to 6 months
Change in social support for diet
Time frame: baseline to 6 months
Change in social support for physical activity
Time frame: baseline to 6 months
Change in perceived stress
Time frame: baseline to 6 months
change in % weight
Time frame: baseline to 1 year
change in absolute weight
Time frame: baseline to 1 year
change in muscle strength
Time frame: baseline to 1 year
change in liver stiffness and CAP
Time frame: baseline to 1 year
change in liver enzymes
Time frame: baseline to 1 year
change in lipids
Time frame: baseline to 1 year
change in physical activity level
Time frame: baseline to 1 year
change in physical activity level
Time frame: baseline to 6months
Change in dietary self-efficacy
Time frame: baseline to 1 year
Change in physical activity self-efficacy
Time frame: baseline to 1 year
Change in social support for diet
Time frame: baseline to 1 year
Change in social support for physical activity
Time frame: baseline to 1 year
change in average weekly minutes of moderate-to-vigorous physical activity
Time frame: baseline to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- This website provide a description of the Paso program. It also gives study participants electronic access to session materials and meal plans.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Balakrishnan principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paso Program in people with Metabolic Dysfunction Associated Steatotic Liver Disease and Overweight (BMI > 25), run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasbility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.