A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease
概览
- 阶段
- 不适用
- 干预措施
- Intervention Group
- 疾病 / 适应症
- Liver Diseases
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in FIB-4 score
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.
详细描述
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.
研究者
入排标准
入选标准
- •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:
- •Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)
- •Blood pressure ≥130/85 mmHg or specific drug treatment
- •Plasma triglycerides ≥150 mg/dl or specific drug treatment
- •Plasma HDL-cholesterol \<40 mg/dl for men and \<50 mg/dl for women, or specific drug treatment
- •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
- •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:
- •chronic HBV (HBsAg+ or taking anti-HBV therapy), or
- •chronic HCV (
- •detectable HCV RNA \> 4 months or a
排除标准
- •Pregnant or planning to become pregnant in next 12 months (by self-report)
- •Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet
- •Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet
- •Current or prior history of primary liver cancer or cancer that is metastatic to the liver
- •AUDIT-10 score \>15
- •Family or household member already enrolled into study
研究组 & 干预措施
Arm 1: Immediate Intervention
participants will receive the 6 months intervention immediately
干预措施: Intervention Group
Arm 2: Delayed Intervention
participants will receive the intervention after the 6-month follow-up visit
干预措施: Control Group
结局指标
主要结局
Change in FIB-4 score
时间窗: up to 6 months
a serum-based biomarker of fibrosis