User Engagement, Acceptability, and Clinical Markers in a Digital Health Program for Nonalcoholic Fatty Liver Disease: Prospective, Single-Arm Feasibility Study (Preprint)
Authors: Björnsdottir Sigridur , Ulfsdottir Hildigunnur , Gudmundsson Elias Freyr , Sveinsdottir Kolbrun , Isberg Ari Pall , Dobies Bartosz , Akerlie Magnusdottir Gudlaug Erla , Gunnarsdottir Thrudur , Karlsdottir Tekla , Bjornsdottir Gudlaug , Sigurdsson Sigurdur , Oddsson Saemundur , Gudnason Vilmundur 
Published: October 2023

BACKGROUND

Nonalcoholic fatty liver disease (NAFLD) has become the most common chronic liver disease in the world. Common comorbidities are central obesity, type 2 diabetes mellitus, dyslipidemia, and metabolic syndrome. Cardiovascular disease is the most common cause of death among people with NAFLD, and lifestyle changes can improve health outcomes.

OBJECTIVE

This study aims to explore the acceptability of a digital health program in terms of engagement, retention, and user satisfaction in addition to exploring changes in clinical outcomes, such as weight, cardiometabolic risk factors, and health-related quality of life.

METHODS

We conducted a prospective, open-label, single-arm, 12-week study including 38 individuals with either a BMI &gt;30, metabolic syndrome, or type 2 diabetes mellitus and NAFLD screened by FibroScan. An NAFLD-specific digital health program focused on disease education, lowering carbohydrates in the diet, food logging, increasing activity level, reducing stress, and healthy lifestyle coaching was offered to participants. The coach provided weekly feedback on food logs and other in-app activities and opportunities for participants to ask questions. The coaching was active throughout the 12-week intervention period. The primary outcome was feasibility and acceptability of the 12-week program, assessed through patient engagement, retention, and satisfaction with the program. Secondary outcomes included changes in weight, liver fat, body composition, and other cardiometabolic clinical parameters at baseline and 12 weeks.

RESULTS

In total, 38 individuals were included in the study (median age 59.5, IQR 46.3-68.8 years; n=23, 61% female). Overall, 34 (89%) participants completed the program and 29 (76%) were active during the 12-week program period. The median satisfaction score was 6.3 (IQR 5.8-6.7) of 7. Mean weight loss was 3.5 (SD 3.7) kg (<i>P</i>&lt;.001) or 3.2% (SD 3.4%), with a 2.2 (SD 2.7) kg reduction in fat mass (<i>P</i>&lt;.001). Relative liver fat reduction was 19.4% (SD 23.9%). Systolic blood pressure was reduced by 6.0 (SD 13.5) mmHg (<i>P</i>=.009). The median reduction was 0.14 (IQR 0-0.47) mmol/L for triglyceride levels (<i>P</i>=.003), 3.2 (IQR 0.0-5.4) µU/ml for serum insulin (s-insulin) levels (<i>P</i>=.003), and 0.5 (IQR –0.7 to 3.8) mmol/mol for hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) levels (<i>P</i>=.03). Participants who were highly engaged (ie, who used the app at least 5 days per week) had greater weight loss and liver fat reduction.

CONCLUSIONS

The 12-week-long digital health program was feasible for individuals with NAFLD, receiving high user engagement, retention, and satisfaction. Improved liver-specific and cardiometabolic health was observed, and more engaged participants showed greater improvements. This digital health program could provide a new tool to improve health outcomes in people with NAFLD.

CLINICALTRIAL

Clinicaltrials.gov NCT05426382; https://clinicaltrials.gov/study/NCT05426382