Clinical trial NCT05426382: A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease
Official title: Sidekick Health Digital Solution (SK-241) for Individuals With Non Alcoholic Fatty Liver Disease (NAFLD): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Alcoholic Fatty Liver Disease
Keywords: non alcoholic fatty liver disease
digital solution
lifestyle change
remote monitoring
clinical outcome
quality of life
digital intervention
non-alcoholic steatohepatitis
Lead sponsor: Sidekick Health
Sponsor class: INDUSTRY
Collaborators: name: Hjartamiðstöðin, Iceland
name: Hjartavernd, Iceland
First posted: 2022-06-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-center single-arm open label intervention study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adults with a NAFLD diagnosis, defined as:

Confirmed liver steatosis \>5%, with a FibroScan CAP cutoff score of \> 294 decibel (dB)/m among individuals with one or more of the following: Type 2 diabetes OR BMI\>30 OR Metabolic syndrome OR Previous diagnosis of NAFLD within the last 12 months

* for individuals with type 2 diabetes: Stable dose of antidiabetic medication the last 90 days before screening (metformin, glitazones, glucagon like peptide-1 (GLP-1) analogues, sodium-glucose co transporter-2 (SGLT-2) inhibitor, sulfonylurea, insulin)
* Capacity to give informed consent and understands verbal and written Icelandic
* Owns and knows how to operate a smartphone
* Willing and able to comply with the study intervention, all scheduled visits and procedures

Exclusion Criteria:

* Insulin use
* Known or self-reported cirrhosis
* Alcohol consumption over 14 units/week for males, 7 units/week for women
* Self-reported Hepatitis B (HepB), Hepatitis C (HepC), human immunodeficiency virus (HIV), or autoimmune hepatitis
* Vitamin E intake of \> 400 IU/day - unless stable for 12 weeks prior to baseline
* Taking medications associated with liver steatosis; steroids, methotrexate, tamoxifen, amiodarone, tetracycline, valproic acid
* Self-reported pregnancy
* Participation in a weight loss program
* History of, or any existing medical condition (e.g., ongoing cancer treatment, severe cardiopulmonary- or musculoskeletal disease, stroke, or myocardial infarction in the last 6 months) that, in the opinion of the investigator, would interfere with evaluation of the study intervention or affect the interpretation of the results of the study

Primary outcomes:
measure: Acceptability and feasibility of the digital program (SK-241) - retention.
timeFrame: 12 weeks
measure: Acceptability and feasibility of the digital program (SK-241) - engagement.
timeFrame: 12 weeks
measure: Acceptability and feasibility of the digital program (SK-241) - satisfaction.
timeFrame: 12 weeks
Secondary outcomes:
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on weightloss.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on HbA1c.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting glucose.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting insulin.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver function.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on cholesterol.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on hs-CRP.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor blood pressure
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor waist circumference.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor activity level.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on body composition.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver fat content.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by assessing health related quality of life (HRQoL)
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by assessing mental health.
timeFrame: 9 months
measure: The feasibility of adding a digital program (SK-241) to standard of care, by assessing medication adherence.
timeFrame: 9 months
Other outcomes:
measure: Exploratory objective: liver steatosis
timeFrame: 9 months
measure: Exploratory objective: liver fibrosis
timeFrame: 9 months
measure: Safety objective: Monitor the safety and any potential adverse effects of the digital solution on patients and outcomes.
timeFrame: 9 months
Locations:
city: Kopavogur
country: Iceland
facility: Hjartamiðstöðin
city: Kópavogur
country: Iceland
facility: Hjartavernd
Study officials:
affiliation: Hjartamiðstöðin
name: Sigríður Björnsdóttir, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: