Metabolic Dysfunction Associated Steatotic Liver Disease, Metabolic Syndrome, Overweight (BMI > 25)
Conditions
Keywords
metabolic dysfunction associated steatotic liver disease, adapted weight loss intervention, weight loss, intervention feasibility, behavior change, metabolic syndrome, overweight/obesity
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.
Interventions
BEHAVIORALPaso 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.
Sponsors
Baylor College of Medicine
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a single arm trial testing the feasibility of the behavioral weight loss program. All study participants will receive the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasbility | 6 months | Average attendance \> 8 sessions across participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in percent weight | baseline to 6 months | average percent change in weight |
| change in absolute weight | baseline to 6 months | Average absolute weight change (kg) |
| change in muscle strength | baseline to 6 months | 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 6 months | 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 6 months | 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 6 months | Change in dietary self-efficacy assessed using Schwarzer \& Renner scale |
| Change in physical activity self-efficacy | baseline to 6 months | Change in physical activity self-efficacy assessed using Schwarzer \& Renner scale |
| Change in social support for diet | baseline to 6 months | Change in diet social support assessed using Sallis perceived social support scale |
| Change in social support for physical activity | baseline to 6 months | 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 1 year | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaya Balakrishnan
Baylor College of Medicine
Outcome results
None listed