"CAP" Fetge Gras. Lifestyle Modification Program in Catalonia.
Condition: Non-Alcoholic Fatty Liver Disease; Liver Diseases; Lifestyle, Healthy
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The main purpose of this study is to investigate whether an online lifestyle modification
      program for people with Metabolic Associated Fatty Liver Disease (MAFLD) through a mobile
      application produces a significant reduction in liver steatosis and is associated with a
      higher rate of weight loss compared to standard recommendations currently indicated in
      Primary Care.
    

Detailed description: 
      Chronic liver disease are very common and potentially severe. For the most part, they are
      diagnosed in an advanced stage, which prevents the introduction of curative treatments.

      MAFLD is currently the most common cause of chronic liver disease affecting approximately 25%
      of the world's population. MAFLD is characterized by an excessive accumulation of liver fat
      associated with insulin resistance (IR) which is defined by the presence of steatosis in> 5%
      of hepatocytes according to histological analysis.

      Currently, the only effective strategy for treating MAFLD is weight loss. Several studies
      show that a 3-5% weight loss manages to reduce hepatic steatosis and associated metabolic
      parameters. Despite this, a reduction of at least 7-10% is required to improve fibrosis.
      Guidelines from the European Association for the Study of Liver Diseases (EASL) and the
      American Association for the Study of Liver Diseases (AASLD) recommend following an
      energy-restricted diet adjusted to the Mediterranean diet, excluding MAFLD-promoting
      components (processed products and high in added fructose), and perform physical activity in
      order to achieve this goal. However, it is a difficult goal to achieve and maintain over
      time. Epidemiological evidence recommends implementing structured lifestyle modification
      programs with the goal of losing weight.

      In people with MFGNA, participation in structured lifestyle programs may be compromised by
      work and time constraints. An application-based online intervention may be more appropriate
      for young people, people of working age, and those living far from primary care. EHealth
      technology is a possible resource for promoting behavior change but is a little-studied field
      in lifestyles modification of people with MAFLD. Given the lack of information regarding
      lifestyle modification programs in people with MAFLD as the main therapeutic intervention in
      Primary Care (PC), we consider to analyze the effectiveness of an online program based on the
      Mediterranean diet with calorie restriction, associated with specific goals of weight loss
      and physical activity, which allows to reduce hepatic steatosis of individuals with MAFLD.

      This study, along with studies of early detection of chronic liver disease through liver
      elastography "LiverScreen", aims to be the beginning of the approach to chronic liver disease
      in Primary Care. The aim of this study is to evaluate a strategy for treating MAFLD.
    

Intervention name(s): Intervention CFG App; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Online healthy lifestyle education through an App. The intervention will consist of viewing educational videos on diet and exercise through an App. Videos will be uploaded to the app on a weekly basis, lasting 2-3.; Standard tips for healthy lifestyles that are carried out in regular Primary Care practice. After day 1, where standard advice is received, follow-up visits are conducted at week 2, week 4, month 3, and month 6.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase III, single-centre, randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment