Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05426382

A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:
Sidekick Health Digital Solution (SK-241) for Individuals With Non Alcoholic Fatty Liver Disease (NAFLD): A Feasibility Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05426382
Study type Interventional
Source Sidekick Health
Contact
Status Completed
Phase N/A
Start date June 20, 2022
Completion date April 24, 2023
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02248311 - "Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population N/A
Completed NCT01277237 - The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease Phase 3
Active, not recruiting NCT04442620 - Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity N/A
Completed NCT01999101 - Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Phase 2
Completed NCT01327443 - Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease N/A
Active, not recruiting NCT01482065 - The Sleep, Liver Evaluation and Effective Pressure Study N/A
Completed NCT03135873 - Mastiha Treatment for Obese With NAFLD Diagnosis N/A
Completed NCT02686476 - Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes N/A
Completed NCT02820285 - Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH N/A
Completed NCT01556113 - Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease N/A
Recruiting NCT06080386 - UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)
Terminated NCT02134522 - The Role of Obstructive Sleep Apnea in Children With Fatty Liver Disease N/A
Completed NCT01553500 - Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease Phase 2
Completed NCT03300661 - Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine N/A
Not yet recruiting NCT02178839 - The Effect of Oral β- Glucan Supplement on Appetite and Insulin Resistance in Non Alcoholic Fatty Liver Disease N/A
Recruiting NCT02038387 - Prospective Clinical Study of the Role of the Immune Response, in Relation to Diet, in Patients Affected by Either Chronic Hepatitis C Virus (HCV) Infection or Non Alcoholic Fatty Liver Disease (NAFLD) N/A
Completed NCT01634048 - The Effect of Protein-enriched Diet on Body Composition and Appetite N/A
Completed NCT01874249 - Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease N/A
Completed NCT01966627 - Genetics of Fatty Liver Disease in Children N/A
Terminated NCT01842282 - Amlexanox for Type 2 Diabetes and Obesity Phase 2