A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Sidekick Health has developed a digital behavioral change program (SK-241) specifically
      designed for people with metabolic derangements and non-alcoholic fatty liver disease
      (NAFLD). The SK-241 is delivered through a mobile application and aims at improving lifestyle
      and health outcomes by focusing on improving diet, increasing activity levels and reducing
      stress. In this study, the feasibility of the newly developed digital behavioral change
      program (SK-241) will be evaluated in a minimum of 30 individuals with a NAFLD diagnosis. The
      primary aim is to explore the acceptability of the SK-241 program by its users, in addition
      to exploring changes in clinical outcomes and medication adherence after a 12-week
      intervention with 6 months follow up.
    

Detailed description: 
      Non-alcoholic fatty liver disease (NAFLD) is an umbrella term used to describe a spectrum of
      liver pathology, characterized by >5% fat accumulation in the liver (steatosis), among people
      who drink little or no alcohol. Both genetic and lifestyle-related factors contribute to the
      pathogenesis of NAFLD. It is strongly associated with metabolic derangements, obesity,
      insulin resistance and type 2 diabetes mellitus. NAFLD is considered the liver manifestation
      of metabolic syndrome.

      NAFLD can progress from a simple steatosis to a more severe and progressive condition,
      referred to as non-alcoholic steatohepatitis (NASH), which is characterized by additional
      liver inflammation and hepatocyte injury with or without fibrosis. In general, 20% of NAFLD
      patients are believed to progress to NASH.

      Finding convenient and effective ways to incorporate lifestyle changes into daily lives of
      people with NAFLD and NASH is important. Sidekick Health has developed a digital behavioral
      change program (SK-241) for NAFLD and NASH patients consisting of an interactive mobile
      application.

      The aim of this study is primarily to assess the acceptability and feasibility of adding a
      digital lifestyle intervention (SK-241) to the standard of care (SoC) for NAFLD patients, by
      assessing participants engagement, retention and satisfaction with the SK-241 program in a
      minimum of 30 individuals with a NAFLD diagnosis. In addition, the clinical effectiveness of
      the program will be explored. A minimum of 30 individuals with a NAFLD diagnosis will be
      included for a 12-week intervention with 6 months follow-up.
    

Intervention name(s): A digital care solution for patients with NAFLD
Intervention type(s): Device
Intervention description(s): A digital solution that provides remote symptom monitoring and support of healthy lifestyle choices through tasks that are made more attractive with gamification and rewards.
Other intervention name(s): SK-241
Intervention model: Single Group Assignment
Intervention model description: Multi-center single-arm open label intervention study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non alcoholic fatty liver disease; digital solution; lifestyle change; remote monitoring; clinical outcome; quality of life; digital intervention; non-alcoholic steatohepatitis