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 Details — Status: Completed

Administrative data

• NCT number: NCT05426382
• Other study ID #: SK-241-NAFLD
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: April 24, 2023

Study information

• Verified date: April 2023
• Source: Sidekick Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non Alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Device:
• A digital care solution for patients with NAFLD
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.

Locations

Country	Name	City	State
Iceland	Hjartamiðstöðin	Kopavogur
Iceland	Hjartavernd	Kópavogur

Sponsors (3)

Lead Sponsor	Collaborator
Sidekick Health	Hjartamiðstöðin, Iceland, Hjartavernd, Iceland

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory objective: liver steatosis	Changes in Controlled Attenuation Parameter (CAP) Fibroscan score. CAP Fibroscan score is measured in decibels per meter (dB/m) and assessed at baseline, week 12 and 9 months.; CAP Fibroscan scores range from from 100 to 400 dB/m, with a lower score indicating a better outcome as it indicates less liver steatosis.	9 months
Other	Exploratory objective: liver fibrosis	Changes in Liver Stiffness Measurement (LSM) Fibroscan score.The LSM Fibroscan scores are measured in kilopascal (kPa) and assessed at baseline, week 12 and 9 months.; LSM FibroScan scores range from 2.5 kPa to 75 kPa. A lower scores indicates a better outcome.	9 months
Other	Safety objective: Monitor the safety and any potential adverse effects of the digital solution on patients and outcomes.	Incidence of adverse events (AE) and serious adverse events (SAE) reportings at week 12 and 9 months.	9 months
Primary	Acceptability and feasibility of the digital program (SK-241) - retention.	Assess retention by percentage of users that complete the SK-241 program at week 12. 'Complete the program' is defined as finishing 75% of the program.	12 weeks
Primary	Acceptability and feasibility of the digital program (SK-241) - engagement.	Assess engagement by percentage of users that are active in the SK-241 program during the 12 weeks. 'Active' is defined as visiting the application at least once per week.	12 weeks
Primary	Acceptability and feasibility of the digital program (SK-241) - satisfaction.	Assess satisfaction based on the scores in the 18-item mobile health (mHealth) App Usability Questionnaire at week 12.; Answers are scored on a 7-point Likert scale (ranging from 1 for "strongly disagree"to 7 "strongly agree") and total scores range from 18 to 126. The higher the score, the better the usability.	12 weeks
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on weightloss.	Change in weight, from baseline to week 12 and month 9	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on HbA1c.	Changes, from baseline to week 12 and month 9 in: Hemoglobin A1c (HbA1c), expressed in millimol per mol (mmol/mol).	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting glucose.	Changes, from baseline to week 12 and month 9 in: fasting glucose, measured in millimol per liter (mmol/L)	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting insulin.	Changes, from baseline to week 12 and month 9 in: fasting insulin, measured in picomol per liter (pmol//L)	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver function.	Changes, from baseline to week 12 and month 9, in liver enzymes in the serum: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma- Glutamyl Transferase (GGT), all measured in international units per liter (IU/L)	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on cholesterol.	Changes, from baseline to week 12 and month 9 in: Total cholesterol, Low Density Lipoprotein - Cholesterol (LDL-C), High Density Lipoprotein - Cholesterol (HDL-C), and triglycerides. These are all measured in millimol per liter (mmol/L)	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on hs-CRP.	Changes, from baseline to week 12 and month 9, in: high-sensitivity C-reactive protein (hs-CRP), measured in milligram per liter (mg/L)	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor blood pressure	Changes, from baseline to week 12 and month 9, in: Blood pressure in millimeters of mercury (mmHg)	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor waist circumference.	Changes, from baseline to week 12 and month 9, in: Waist circumference in centimeters (cm)	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor activity level.	Changes, from baseline to week 12 and month 9, in: Activity level, as assessed with an in-app step counter, and measured in number of steps	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on body composition.	Changes in body composition (fat mass and lean mass), measured by dual-energy X-ray absorptiometry (DXA) at baseline, week 12 and 9 months.; Fat mass and lean mass are both expressed as percentage (%).	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver fat content.	Changes in liver fat fraction (%) assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at baseline, week 12 and 9 months.	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by assessing health related quality of life (HRQoL)	Changes in self-reported scores on the EuroQuol Five Dimension - Five Level (EQ-5D-5L) health questionnaire from baseline to week 12 and month 9.; EQ-E5-5L scores range from -0.530 to 1, with higher scores indicating a better health status. A score of 1 indicates full health.	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by assessing mental health.	Changes in self-reported scores of the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) questionnaire from baseline to week 12 and month 9.; Each question has a Likert scale of 4 options where 0 represents "did not apply to me" to 3 "applied to me very much". The scores on the subscales range from 0 to 42, and low scores indicate a better mental health status.	9 months
Secondary	The feasibility of adding a digital program (SK-241) to standard of care, by assessing medication adherence.	Changes in self-reported scores on the Morisky Medication adherence Scale (MMAS-8) questionnaire from baseline to week 12 and month 9. The MMAS-8 is an 8-item structured, self-reported medication adherenece measure.; Scores on the MMAS-8 range from 0-8, with 0 reflecting high adherence, 1-2 medium adherence and 3-8 low adherence.	9 months