Mobile Health Delivered Lifestyle Intervention Program in Patients With Nonalcoholic Steatohepatitis: A Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
There is a clear unmet clinical need for effective lifestyle intervention in patients with nonalcoholic steatohepatitis (NASH). Patients have self-identified multiple barriers to effective lifestyle intervention can be removed with a mobile health (mHealth) platform.
This study will be a proof of concept study to evaluate weight loss efficacy of Noom Healthy Weight (HW), a mHealth lifestyle intervention, in patients with NASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Forty-subjects with NASH will be randomized 1:1 to either receive Noom HW mHealth lifestyle intervention or standard clinical care.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age >18 years
- •NASH defined as:
- •Liver biopsy with evidence of steatohepatitis (NAS >=4) or;
- •Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following:
- •Fibroscan kPa >8.2 or;
- •FAST > 0.35 or;
- •FIB-4 >= 1.45 or;
- •Possession of a smartphone
排除标准
- •Active or recent (<90 days) participation in lifestyle intervention program, including weight-loss program
- •Active weight-loss supplement use
- •Cirrhosis
- •Inability to provide informed consent
- •Institutionalized/prisoner
- •Other chronic liver disease (e.g., viral hepatitis)
- •Recent Noom use (<180 days)
- •Secondary cause of hepatic steatosis, including significant alcohol consumption (men >30g/d, women >20g/d)
- •Severe medical comorbidities/psychiatric illness at the discretion of the study PI
结局指标
主要结局
Weight
时间窗: 16 weeks
Change in self-measured body weight
次要结局
- Ferritin(16 weeks)
- hemoglobin A1c(16 weeks)
- histology(16 weeks)
- liver enzymes(16 weeks)
- NAFLD Fibrosis Score(16 weeks)
- Cholesterol level(16 weeks)
- Noom healthy weight engagement(16 weeks)
- Glucose(16 weeks)
- IgA level(16 weeks)
研究者
Jonathan Stine
Director of Research, Penn State Liver Center, Assistant Professor of Medicine and Public Health Sciences
Milton S. Hershey Medical Center