JMIR Publications

ABSTRACT

Background:

Cardiovascular disease (CVD) is the leading cause of death in the United States, affecting a significant proportion of adults. Digital health lifestyle change programs have emerged as a promising method of CVD prevention, offering benefits such as on-demand support, lower cost, and increased scalability. Prior research has shown the effectiveness of digital health interventions in reducing negative CVD outcomes. This pilot study focuses on the Lark Heart Health program, a fully digital artificial intelligence (AI)-powered smartphone application, providing synchronous CVD risk counseling, educational content, and personalized coaching.

Objective:

This pilot study evaluated the feasibility and acceptability of a fully digital lifestyle change program called Lark Heart Health. Primary analyses assessed participant satisfaction, engagement with the program, and the submission of health screeners. Secondary analyses were conducted to evaluate weight loss outcomes.

Methods:

This study enrolled 509 participants into the 90-day real-world, non-interventional, single-arm, observational, pilot study of the Heart Health app. Participants engaged with the app through coaching conversations, logging meals, tracking weight, and completing educational lessons. Study outcomes included participant satisfaction, app engagement, completion of screeners, and weight loss.

Results:

On average, Heart Health study participants were 61 (40-75) years old, with average body mass index indicating class I obesity. There were 489 participants who stayed enrolled until the end of the study. Study retention, based on providing a weight measurement during Month 3, was 80.0% (407/509; CI = 76.2,83.4%). Participant satisfaction scores indicated high satisfaction with the overall app experience, with an average score of >4 of 5 for all satisfaction indicators. Participants also showed high engagement with the app, with 83% (408/489; CI = 80.1-86.7%) of the sample meeting criteria for being highly engaged in Month 3. Results indicated that participants were successfully able to submit health screeners within the app, with 89.8% (440/489; CI = 87.0, 92.5%) submitting all three screeners measured in the study. Lastly, secondary analyses showed that participants lost weight during the program, with analyses showing an average weight nadir of 3.8% (CI = 3.5,4.1).

Conclusions:

The present results indicate that participants in this study were satisfied with their experience using the Heart Health app, highly engaged with app features, and willing and able to complete health screening surveys in the app. These acceptability and feasibility results provide a key first step in the process of evidence generation for a new AI-powered digital program for heart health.