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| ID | Type | Description | Link |
|---|---|---|---|
| K23MD016955 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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"). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paso Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasbility | Average attendance > 8 sessions across participants | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in percent weight | average percent change in weight | baseline to 6 months |
| change in absolute weight | Average absolute weight change (kg) |
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Inclusion Criteria:
Exclusion Criteria:
≥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,
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)
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| Name | Affiliation | Role |
|---|---|---|
| Maya Balakrishnan | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harris Health - Smith | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| This website provide a description of the Paso program. It also gives study participants electronic access to session materials and meal plans. | View source |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: IRB protocol report | Oct 9, 2024 |
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This is a single arm trial testing the feasibility of the behavioral weight loss program. All study participants will receive the intervention.
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| 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 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 |
| 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 |
| Feb 21, 2025 |
| Prot_SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: Full protocol | Feb 5, 2025 | Feb 21, 2025 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: English Consent Form | Oct 9, 2024 | Feb 21, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D024821 | Metabolic Syndrome |
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |
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