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Non Alcoholic Fatty Liver DiseaseNCT05426382

A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease

A study testing A digital care solution for patients with NAFLD in people with Non Alcoholic Fatty Liver Disease, run by Sidekick Health at 2 sites in Iceland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Non Alcoholic Fatty Liver Disease
What is being tested?
A digital care solution for patients with NAFLD
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
2 sitesIceland
Study dates
20 Jun 2022to 24 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Iceland2 sites

  • Hjartamiðstöðin

    Kopavogur, 203

  • Hjartavernd

    Kopavogur, 203

Other trials in Iceland

About this study

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

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.

Read the 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.

Being tested
A digital care solution for patients with NAFLD
Keywords
non alcoholic fatty liver disease, digital solution, lifestyle change, remote monitoring, clinical outcome, quality of life, digital intervention, non-alcoholic steatohepatitis
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A digital care solution for patients with NAFLDDevice

    Also called SK-241

    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.

Study groups in NCT05426382
Study groupRoleWhat they receive
Digital solution groupExperimentalParticipants 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.
Receives: Device: A digital care solution for patients with NAFLD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

Secondary outcomes (15)

  1. 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

    Measured: 9 months

  2. 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).

    Measured: 9 months

  3. 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)

    Measured: 9 months

  4. 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)

    Measured: 9 months

  5. 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)

    Measured: 9 months

  6. 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)

    Measured: 9 months

  7. 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)

    Measured: 9 months

  8. 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)

    Measured: 9 months

  9. 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)

    Measured: 9 months

  10. 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

    Measured: 9 months

  11. 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 (%).

    Measured: 9 months

  12. 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.

    Measured: 9 months

  13. 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.

    Measured: 9 months

  14. 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.

    Measured: 9 months

  15. 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.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2022
  2. Study start20 Jun 2022
  3. Primary completion24 Apr 2023
  4. Study completion24 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multi-center single-arm open label intervention study
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05426382
Sponsor's protocol ID
SK-241-NAFLD
Status last verified
Apr 2023
First submitted
10 Jun 2022
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymized Individual Participant Data (IPD) may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.

Publications

  • 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.

    PubMed 38152892

Questions about this trial

What is this clinical trial studying?

A study testing A digital care solution for patients with NAFLD in people with Non Alcoholic Fatty Liver Disease, run by Sidekick Health at 2 sites in Iceland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability and feasibility of the digital program (SK-241) - retention. (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05426382, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.

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