Effect of the WARIFA app on user-defined objectives, healthy lifestyles and management of type 1 diabetes (T1D): a pilot randomised controlled trial protocol (Preprint)

<sec> <title>BACKGROUND</title> Non-communicable diseases (NCDs) are the leading cause of death and have a high global prevalence. The four main diseases are cardiovascular and respiratory diseases, cancer and diabetes, which share common risk factors and can be prevented through physical activity, a healthy diet, avoiding smoking and alcohol consumption, and other lifestyle changes. Watching the Risk Factors (WARIFA) is a mHealth application (app) created for general health awareness and to support users in adopting healthier behaviours. It also has a functionality to support type 1 diabetes (T1D) management. </sec> <sec> <title>OBJECTIVE</title> To evaluate the effectiveness of the WARIFA app with personalised artificial intelligence (AI) driven messages, compared to a non-personalised version, in promoting health-related behaviour change among general population and individuals with T1D. </sec> <sec> <title>METHODS</title> A total of 108 European participants, including individuals with T1D, are randomised (computer-generated sequence, double-blind, 1:1 ratio) to an intervention or control group. In the intervention group, participants use the WARIFA app with personalised messages and the use of AI. This applies to some functionalities, such as personalised recommendations and risk prediction for the four main NCDs. In the control group, participants use a WARIFA app without personalised messages or AI. Both groups are provided with an activity monitor and will use the WARIFA app for 12 weeks. The primary outcome is a self-defined goal, chosen from a set of proposed objectives at baseline and assessed at the end of the study using a Likert scale (0 to 10 points, 0 being no achievement at all and 10 being full achievement of the proposed objective). Secondary outcomes include: engagement with the app, changes in lifestyle behaviour, body composition, lipid profile, glycated haemoglobin (T1D only), hypoglycaemic events (T1D only) and health related quality of life, as well as acquired knowledge, self-efficacy and usability. </sec> <sec> <title>RESULTS</title> . </sec> <sec> <title>CONCLUSIONS</title> There is evidence that improving lifestyle behaviour can prevent NCDs. In this study, we aim to evaluate the effectiveness of the WARIFA app to improve lifestyle behaviours and T1D management. </sec> <sec> <title>CLINICALTRIAL</title> NCT06918444. </sec>