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Accepted for/Published in: JMIR Cardio

Date Submitted: Sep 12, 2023
Date Accepted: Dec 26, 2023
Date Submitted to PubMed: Dec 28, 2023

The final, peer-reviewed published version of this preprint can be found here:

User Engagement, Acceptability, and Clinical Markers in a Digital Health Program for Nonalcoholic Fatty Liver Disease: Prospective, Single-Arm Feasibility Study

Björnsdottir S, Ulfsdottir H, Gudmundsson EF, Sveinsdottir K, Isberg A, Dobies B, 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;8:e52576

DOI: 10.2196/52576

PMID: 38152892

PMCID: 10905363

User Engagement, Acceptability and Clinical Markers in a Digital Health Program for Non-Alcoholic Fatty Liver Disease (NAFLD): A feasibility study

  • Sigridur Björnsdottir; 
  • Hildigunnur Ulfsdottir; 
  • Elias Freyr Gudmundsson; 
  • Kolbrun Sveinsdottir; 
  • Ari Isberg; 
  • Bartosz Dobies; 
  • Gudlaug E.A. Magnusdottir; 
  • Thrudur Gunnarsdottir; 
  • Tekla Karlsdottir; 
  • Gudlaug Bjornsdottir; 
  • Sigurdur Sigurdsson; 
  • Saemundur Oddsson; 
  • Vilmundur Gudnason

ABSTRACT

Background:

Cardiovascular disease is the most common cause of death among people with non-alcoholic fatty liver disease (NAFLD) and lifestyle changes can improve health outcomes.

Objective:

To explore the acceptability of a digital health program in addition to exploring changes in clinical outcomes, such as weight, cardiometabolic risk factors, and health related quality of life

Methods:

A prospective open-label, single-arm, 12-week study including individuals with either BMI>30, metabolic syndrome or type 2 diabetes mellitus and NAFLD, screened by FibroScan. A digital health program focused on disease education, low carbohydrate diet, increasing activity levels, reducing stress and healthy lifestyle coaching was offered to participants. The primary outcome was feasibility and acceptability; secondary outcomes included liver fat changes, body composition and other clinical parameters at baseline and 12 weeks.

Results:

Thirty-eight individuals were included; median age 59.5 years, 60.5% female, 34 (89%) completed the program, 29 (76%) were active during the study. Median satisfaction score (MAUQ): 6.3 /7. Mean weight loss (SD): 3.5 (3.7) kg (p<0.001) or 3.2% (3.4), with 2.2 (2.7) kg reduction in fat mass (p<0.001). Relative liver fat reduction (SD): 19.4% (23.9). Systolic blood pressure (SD) reduced by 6.0 (13.5) mmHg (p=0.009), triglyceride levels by median (IQR) of 0.14 (0–0.47) mmol/L (p=0.003), s-insulin levels by 3.2 (0.0–5.4) µU/ml (p=0.003) and HbA1c levels by 0.5 (-0.7–3.8) mmol/mol (p=0.033).

Conclusions:

The digital health program was feasible for individuals with NAFLD and improved liver-specific and cardiometabolic health. This could provide a new tool to improve health outcomes in people with NAFLD. Clinical Trial: The study was registered at clinicaltrials.gov under the trial identifier NCT05426382.


 Citation

Please cite as:

Björnsdottir S, Ulfsdottir H, Gudmundsson EF, Sveinsdottir K, Isberg A, Dobies B, 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;8:e52576

DOI: 10.2196/52576

PMID: 38152892

PMCID: 10905363

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