A Randomized Controlled Pilot Trial of a Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score
研究概览
简要总结
This study will look at physical activity and nutrition in patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). The researchers will see if providing patients with NAFLD/NASH with specific physical activity and nutrition feedback as an addition to their usual clinical care helps them to lose weight and improve liver-related parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH)
- •Access to mobile phone/tablet/ or computer compatible with FitBit application and ability to use said device and application
- •Ability to participate in physical activity
排除标准
- •Any other form of liver disease( Alcohol related liver disease; viral hepatitis, autoimmune liver disease, hereditary forms of liver disease, etc.)
- •History of decompensated cirrhosis
- •Plans for invasive procedures or other regimented lifestyle programs for weight reduction
- •Cardiovascular event in the previous 3 months
结局指标
主要结局
Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score
时间窗: Baseline, 6 months,
CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat). Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP 12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation.
次要结局
- Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)(Baseline, 6 months)
- Percent Change in Body Weight(Baseline, 6 months)
研究者
Monica Tincopa
Clinical Lecturer in Internal Medicine
University of Michigan