A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease

NCT05426382 | Completed

• 1 other identifier: SK-241-NAFLD
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (15)

• The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on weightloss.

  9 months

• The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on HbA1c.

  9 months

• The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting glucose.

  9 months

• The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting insulin.

  9 months

• The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver function.

  9 months

Other Outcomes (3)

• Exploratory objective: liver steatosis

  9 months

• Exploratory objective: liver fibrosis

  9 months

• Safety objective: Monitor the safety and any potential adverse effects of the digital solution on patients and outcomes.

  9 months

Study Arms (1)

Digital solution group

EXPERIMENTAL

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.

Device: A digital care solution for patients with NAFLD

Interventions

A digital care solution for patients with NAFLD 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.

Also known as: SK-241

Digital solution group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidekick Health: lead
• Hjartamiðstöðin, Iceland: collaborator
• Hjartavernd, Iceland: collaborator

Study Sites (2)

Hjartamiðstöðin

Kopavogur, 203, Iceland

Location

Hjartavernd

Kopavogur, 203, Iceland

Location

Related Publications (1)

• 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.

  PMID: 38152892 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Sigríður Björnsdóttir, MD PhD

  Hjartamiðstöðin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center single-arm open label intervention study

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 22, 2022
• Study Start: June 20, 2022
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IC (2)