Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified Health Condition 2: E889- Metabolic disorder, unspecified
Conditions
Interventions
Intervention1: MyTatva application with device integration: Patients randomised to the intervention arm will receive the MyTatva mobile app., lifestyle intervention via health coaches, and routine phy
Sponsors
Digicare Health Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with 7 percentage and above body weight in kgs reduction from baseline to the end of 12 weeks and 24 weeks Change in waist circumference in cm from baseline to the end of 12 weeks and 24 weeks Change in CAP score in deciBels per meter from baseline to the end of 12 weeks and 24 weeksTimepoint: 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Waist-Hip Ratio in cm from baseline to the end of 12 weeks and 24 weeks Change in LSM via FibroScan from baseline to the end of 12 weeks and 24 weeks Change in HOMA IR from baseline to the end of 12 weeks and 24 weeks Change in FIB 4 and FAST scores from baseline to the end of 12 weeks and 24 weeks Change in Patient Related Outcome via Chronic Liver Disease Questionnaire from baseline to the end of 12 weeks and 24 weeks Change in the body fat percentage from baseline to the end of 12 weeks and 24 weeks Change in muscle mass from baseline to the end of 12 weeks and 24 weeks Change in physical activity measured in step counts per day from baseline to the end of 12 weeks and 24 weeks Percentage of patients with 80 percentage adherence to diet and exercise recommendations at the end of 12 weeks and 24 weeks Timepoint: 12 weeks and 24 weeks | — |
Countries
India
Contacts
Public ContactDr Anand V Kulkarni
Digicare Health Solutions Private Limited
Outcome results
None listed