A Prospective, Randomized Controlled Trial to Assess the Impact of MyTatva Application in Management of Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 224
- 试验地点
- 6
- 主要终点
- Proportion of patients with 7 percentage and above body weight in kgs reduction from baseline to the end of 12 weeks and 24 weeks
研究概览
简要总结
MyTatva App, a mobile application (Android version 1.9.7 or higher and iOS version 1.6.8 or higher), is developed by Digital Healthcare Solution Private Limited. Intention for developing MyTatva App is to track, monitor, and keep records of every single parameter that contributes to overall well-being in adults with NAFLD.
MyTatva App takes control of body condition in the smart way and provides an entire disease management ecosystem right at the fingertips.
With personalized diet, behavioral modification and exercise plans, individual can work on improving their health and track their daily activities by connecting to smart devices. The patient can connect with other patients and stay informed about the latest advances with engaging and scientifically verified educational content.
Therefore, this study has been planned to understand the impact of lifestyle modification in diet and exercise delivered by MyTatva application in the management of NAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with confirmed diagnosis of NAFLD Patients with Liver Stiffness Measure (LSM) Values ranges between 7 to 12 kPa measured via FibroScan Patients with access to a smartphone with internet access/data plan Patients or caregivers who understands and speaks English sufficiently to be able to use the MyTatva Patient application Patient is willing to comply with all study procedures and available for the duration of study.
排除标准
- •Patients who have active or recent participation in lifestyle intervention program including a weight loss program less than 90 days before enrolment Patients who are on active weight loss supplement use Patients with LSM values above 12 kPa measured via FibroScan Patients who are unable or not willing to provide informed consent Patients with other chronic liver diseases Patients who have secondary causes of hepatic steatosis, including significant alcohol consumption for men more than 30gram per day and women more than 20gram day Patients who have severe medical comorbidities or psychiatric illness can be excluded at the discretion of the study PI Concurrent enrollment in any other interventional clinical trial at the start of study Enrollment in any other interventional clinical trial 3 months prior to the start of study Presumed or confirmed COVID-19 diagnosis within 30 days prior to study enrollment.
结局指标
主要结局
Proportion of patients with 7 percentage and above body weight in kgs reduction from baseline to the end of 12 weeks and 24 weeks
时间窗: 12 weeks and 24 weeks
Change in waist circumference in cm from baseline to the end of 12 weeks and 24 weeks
时间窗: 12 weeks and 24 weeks
Change in CAP score in deciBels per meter from baseline to the end of 12 weeks and 24 weeks
时间窗: 12 weeks and 24 weeks
次要结局
- Change in Waist-Hip Ratio in cm from baseline to the end of 12 weeks and 24 weeks
研究者
Dr Anand V Kulkarni
AIG Hospitals