Effect of complex weight-reducing interventions on rhythm control in obese individuals with atrial fibrillation following catheter ablation (HOBIT-AF)

Abstract

Introduction: HOBIT-AF is a single-blinded, parallel-group randomised controlled trial with 18-month follow-up to assess the effect of complex weight-reducing interventions supported by the use of smart technologies on the arrhythmia burden in obese individuals following catheter ablation for atrial fibrillation. Participants in the intervention group will be provided with a smartphone and smartwatch at month 3 visit for the rest of the trial and the participants in the control group at month 9 visit for the rest of the trial. A purpose-made mobile application will be pre-installed on smartphone. This application will enable participants to generate an ECG report twice a day and in case of an arrhythmia episode. Participants will be asked to regularly provide their weight, blood pressure and physical activity, and these data, together with heart rate, ECG trace and steps count will be securely transferred to investigators at the local home-monitoring centre. Besides, a custom-made website was designed for the participants of the trial containing useful tips concerning nutrition, cooking tips and physical activities. Purpose: The effect of complex weight-reducing interventions on the arrhytmia burden and quality of life. Methods: One hundred and sixty individuals (age 18-70 years, body mass index≥30 kg/m2) will be randomised in a 1:1 fashion to undergo a structured weight reduction programme aiming to achieve greater than 10% weight reduction from baseline (intervention group) or standard post-ablation medical care (control group). Results: Until 30th September 2021, 31 people were randomized to the intervention group (5 people resigned) and 34 people to the control group (1 person resigned). Since the start of the study, patients in the intervention group reduced their body weight by 5% so far, and most of them (73%) still have 9 months of active intervention to go. Participants in the control group gained on weight an avarage of of 1.6% over the reference period (39% of those surveyed in month 9). Conclusion: This trial will employ smart technologies to increase the motivation and adherence to introduced lifestyle changes.