Using a smartphone app in changing cardiovascular risk factors: A randomized controlled trial (EVIDENT II study)

Abstract

Background and objective: The last few years have seen the appearance many mobile applications aimed at improving health, but studies analyzing their effectiveness on cardiovascular risk factors (CVRFs) are few and far between. Our aim was to assess the effect on CVRFs such as hypertension, dyslipidemia, diabetes and global CVR, of adding the use of a smartphone app to an intervention consisting of standard counseling on physical activity and the Mediterranean diet.

Method: This is a multicenter, randomized and controlled clinical trial. From January 2014 and September 2016, a total of 833 subjects selected by random sampling from six health centers participated. Of these, 415 were assigned to the counseling + app group (IG) and 418 to the counseling only group (CG). The IG additionally received training in the use of a mobile application. The main outcome was the change in CVRFs and estimated CVR at 3 and 12 months in the IG compared to the CG.

Results: No significant changes were observed at 3 or 12 months in terms of CVR. Nevertheless, an effect between groups was observed in favor of the CG at 12 months in some CVRFS: SBP, DBP, total cholesterol and triglycerides: 2.02 mmHg (95%CI: 0.43-3.61), 1.21 mmHg (95%CI: 0.20-2.24), 5.24 mg/dl (95%CI: 1.22-9.26) and 7.24 mg/dl (95%CI: 0.53-14.32).

Conclusion: Adding an intervention with the use of an app for three months to standard counseling on diet and physical activity, does not provide additional benefits for improving CVRFs or the estimated CVR in the long term.

Trial registration number: ClinicalTrials.gov NCT02016014.

Keywords: Cardiovascular risk; Lifestyle; Self-Care; Smartphone applications; mHealth.