- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05426382
A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease
Sidekick Health Digital Solution (SK-241) for Individuals With Non Alcoholic Fatty Liver Disease (NAFLD): A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sigríður Björnsdóttir, MD PhD
- Phone Number: +354 821 7107
- Email: sigridur.bjornsdottir@regionstockholm.se
Study Contact Backup
- Name: Hildigunnur Úlfsdóttir, MD MPH
- Email: hildigunnur@sidekickhealth.com
Study Locations
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Kopavogur, Iceland, 203
- Hjartamiðstöðin
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Kópavogur, Iceland, 203
- Hjartavernd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability and feasibility of the digital program (SK-241) - retention.
Time Frame: 12 weeks
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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
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Acceptability and feasibility of the digital program (SK-241) - engagement.
Time Frame: 12 weeks
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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
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Acceptability and feasibility of the digital program (SK-241) - satisfaction.
Time Frame: 12 weeks
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on weightloss.
Time Frame: 9 months
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Change in weight, from baseline to week 12 and month 9
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9 months
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on HbA1c.
Time Frame: 9 months
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Changes, from baseline to week 12 and month 9 in: Hemoglobin A1c (HbA1c), expressed in millimol per mol (mmol/mol). |
9 months
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting glucose.
Time Frame: 9 months
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Changes, from baseline to week 12 and month 9 in: fasting glucose, measured in millimol per liter (mmol/L) |
9 months
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on fasting insulin.
Time Frame: 9 months
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Changes, from baseline to week 12 and month 9 in: fasting insulin, measured in picomol per liter (pmol//L) |
9 months
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver function.
Time Frame: 9 months
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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
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on cholesterol.
Time Frame: 9 months
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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
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on hs-CRP.
Time Frame: 9 months
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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
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor blood pressure
Time Frame: 9 months
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Changes, from baseline to week 12 and month 9, in: Blood pressure in millimeters of mercury (mmHg) |
9 months
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor waist circumference.
Time Frame: 9 months
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Changes, from baseline to week 12 and month 9, in: Waist circumference in centimeters (cm) |
9 months
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on the cardiovascular risk factor activity level.
Time Frame: 9 months
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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
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on body composition.
Time Frame: 9 months
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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
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The feasibility of adding a digital program (SK-241) to standard of care, by exploring its effects on liver fat content.
Time Frame: 9 months
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Changes in liver fat fraction (%) assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at baseline, week 12 and 9 months.
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9 months
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The feasibility of adding a digital program (SK-241) to standard of care, by assessing health related quality of life (HRQoL)
Time Frame: 9 months
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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
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The feasibility of adding a digital program (SK-241) to standard of care, by assessing mental health.
Time Frame: 9 months
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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
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The feasibility of adding a digital program (SK-241) to standard of care, by assessing medication adherence.
Time Frame: 9 months
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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
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory objective: liver steatosis
Time Frame: 9 months
|
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
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Exploratory objective: liver fibrosis
Time Frame: 9 months
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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
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Safety objective: Monitor the safety and any potential adverse effects of the digital solution on patients and outcomes.
Time Frame: 9 months
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Incidence of adverse events (AE) and serious adverse events (SAE) reportings at week 12 and 9 months.
|
9 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sigríður Björnsdóttir, MD PhD, Hjartamiðstöðin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SK-241-NAFLD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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