Cirrhosis, Liver, Fibrosis, Liver, Liver Diseases
Conditions
Brief summary
To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.
Detailed description
Hypothesis: A technology-assisted self-management intervention that addresses diet, physical activity, alcohol use, and medication adherence can produce regression in fibrosis as measured by FIB-4 in patients with fibrosis or steatosis and risk factors for cirrhosis, including chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, alcohol use, or non-alcoholic fatty liver disease (NAFLD). Primary objective: To test the effect of the behavioral intervention on fibrosis in a randomized trial. We will randomize eligible HOPE Clinic patients to (i) a 6-month self-management intervention to help participants implement behavioral changes to manage their disease or (ii) a wait-list control group that will receive the intervention after their 6-month assessment. Secondary objective: Evaluate changes in behavioral risk factors for liver fibrosis or steatosis (body composition, physical activity, diet, medication adherence, alcohol use), metabolic syndrome, and patient activation and other behavioral determinants.
Interventions
BEHAVIORALIntervention Group
Participants in the intervention group will receive (1) weekly telephone or videoconference coaching; (2) health education print materials and tip sheets;(3) navigation to programs and resources to help participants meet behavioral goals (e.g., fitness events, classes and webinars, etc); (4) text messages related to behavioral skills; (5) a Fitbit activity tracker and Aria scale; (6) resistance tubes and instructional video for strengthening exercise (if resistance exercise module is chosen); and (7) tools to manage portion sizes.
BEHAVIORALControl Group
Patients in the control arm will initially receive written education material about the risk factors for liver cancer and management options. They will be offered the intervention after they complete the 6-month assessment.
Sponsors
M.D. Anderson Cancer Center
Cancer Prevention Research Institute of Texas
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Evidence of steatosis (CAP score ≥ 290 by vibration controlled transient elastography) OR Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography \[F2 score ≥ 8kPa\]) AND meets one of the following criteria: i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), OR ii. presence of type II diabetes mellitus, OR iii. lean/normal weight with presence of at least two metabolic risk abnormalities, OR: 1. Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups) 2. Blood pressure ≥130/85 mmHg or specific drug treatment 3. Plasma triglycerides ≥150 mg/dl or specific drug treatment 4. Plasma HDL-cholesterol \<40 mg/dl for men and \<50 mg/dl for women, or specific drug treatment 5. Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15 AND/OR 2. Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography) and presence of one of the following: 1. chronic HBV (HBsAg+ or taking anti-HBV therapy), or 2. chronic HCV (1. detectable HCV RNA \> 4 months or a 2. history of HCV infection and taking anti-HCV therapy) 3\. At least 18 years old 4. Speak and read English or Spanish 5. Access to smartphone with data plan or Wi-Fi access 6. Willing to receive up to 12 text messages per week
Exclusion criteria
1. Pregnant or planning to become pregnant in next 12 months (by self-report) 2. Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet 3. Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet 4. Current or prior history of primary liver cancer or cancer that is metastatic to the liver 5. AUDIT-10 score \>15 6. Family or household member already enrolled into study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FIB-4 score | up to 6 months | a serum-based biomarker of fibrosis |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKaren Basen-Engquist, MD
M.D. Anderson Cancer Center
Outcome results
None listed