A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease

NCT ID: NCT05426382

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2023-04-24

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.

Conditions

Non Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Digital solution group

Participants will be instructed to download a lifestyle-changing mobile application to which they will have access for 9 months. The program aims to provide remote symptom monitoring by a health coach and by having participants enter data (on diet, exercise, weight, stress and energy levels, etc) and patient reported outcomes (PROs) via the SidekickHealth platform to empower positive lifestyle changes.

The intervention consists of a 12-week digital behavioral change program with an additional 6-month maintenance program, during which time the patient still has access to the application but with limited features compared to the first 12 weeks. During the total 9-month study period all participants will also receive standard of care.

Group Type: EXPERIMENTAL

A digital care solution for patients with NAFLD

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

SK-241

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hjartamiðstöðin, Iceland

UNKNOWN

Sponsor Role: collaborator

Hjartavernd, Iceland

UNKNOWN

Sponsor Role: collaborator

Sidekick Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sigríður Björnsdóttir, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hjartamiðstöðin

Locations

Hjartamiðstöðin

Kopavogur, , Iceland

Hjartavernd

Kopavogur, , Iceland

Countries

Iceland

References

Bjornsdottir S, Ulfsdottir H, Gudmundsson EF, Sveinsdottir K, Isberg AP, Dobies B, Akerlie Magnusdottir GE, Gunnarsdottir T, Karlsdottir T, Bjornsdottir G, Sigurdsson S, Oddsson S, Gudnason V. User Engagement, Acceptability, and Clinical Markers in a Digital Health Program for Nonalcoholic Fatty Liver Disease: Prospective, Single-Arm Feasibility Study. JMIR Cardio. 2024 Feb 15;8:e52576. doi: 10.2196/52576.

Reference Type: DERIVED

PMID: 38152892 (View on PubMed)

Other Identifiers

SK-241-NAFLD

Identifier Type: -

Identifier Source: org_study_id