Long-Term Effectiveness of a Smartphone App and a Smart Band on Arterial Stiffness and Central Hemodynamic Parameters in a Population with Overweight and Obesity (Evident 3 Study): Randomised Controlled Trial

Abstract

Background: mHealth technologies could help to improve cardiovascular health; however, their effect on arterial stiffness and hemodynamic parameters has not been explored to date.

Objective: To evaluate the effect of a mHealth intervention, at 3 and 12 months, on arterial stiffness and central hemodynamic parameters in a sedentary population with overweight and obesity.

Methods: Randomised controlled clinical trial (Evident 3 study). 253 subjects were included: 127 in the intervention group (IG) and 126 in the control group (CG). The IG subjects were briefed on the use of the Evident 3 app and a smart band (Mi Band 2, Xiaomi) for 3 months to promote healthy lifestyles. All measurements were recorded in the baseline visit and at 3 and 12 months. The carotid-femoral pulse wave velocity (cfPWV) and the central hemodynamic parameters were measured using a SphigmoCor System^® device, whereas the brachial-ankle pulse wave velocity (baPWV) and the Cardio Ankle Vascular Index (CAVI) were measured using a VaSera VS-2000^® device.

Results: Of the 253 subjects who attended the initial visit, 237 (93.7%) completed the visit at 3 months of the intervention, and 217 (85.3%) completed the visit at 12 months of the intervention. At 12 months, IG showed a decrease in peripheral augmentation index (PAIx) (-3.60; 95% CI -7.22 to -0.00) and ejection duration (ED) (-0.82; 95% CI -1.36 to -0.27), and an increase in subendocardial viability ratio (SEVR) (5.31; 95% CI 1.18 to 9.44). In CG, cfPWV decreased at 3 months (-0.28 m/s; 95% CI -0.54 to -0.02) and at 12 months (-0.30 m/s, 95% CI -0.54 to -0.05), central diastolic pressure (cDBP) decreased at 12 months (-1.64 mm/Hg; 95% CI -3.19 to -0.10). When comparing the groups we found no differences between any variables analyzed.

Conclusions: In sedentary adults with overweight or obesity, the multicomponent intervention (Smartphone app and an activity-tracking band) for 3 months did not modify arterial stiffness or the central hemodynamic parameters, with respect to the control group. However, at 12 months, CG presented a decrease of cfPWV and cDBP, whereas IG showed a decrease of PAIx and ED and an increase of SEVR.

Keywords: arterial stiffness; central hemodynamic parameters; eHealth; mobile app; mobile phone; telemedicine; weight control.

Figure 1

Study flowchart: recruitment of the subjects and completion of the study.

Figure 2

Evolution of carotid-femoral pulse wave velocity (cfPWV), brachial-ankle pulse wave velocity (baPWV) and Cardio Ankle Vascular Index (CAVI), from baseline to 3 and 12 months comparing the intervention and control groups. p value between groups: cfPWV, p = 0.475; baPWW, p = 0.851 and CAVI, p = 0.749.

Figure 3

Evolution of central systolic blood pressure (cSBP), central diastolic blood pressure (cDBP), Central Augmentation Index, (CAIx) and Peripheral Augmentation Index (PAIx), from baseline to 3 and 12 months comparing the intervention and control groups. p value between groups: cSBP, p = 0.493; cDBP, p = 0.737, CAIx, p = 0.691 and PAIx, p = 0.375.

Figure 4

Evolution of augmentation pressure (AP), ejection duration ratio (ED%), and subendocardial viability ratio (SEVR%), from baseline to 3 and 12 months comparing the intervention and control groups. p value between groups: AP, p = 0.741; ED%, p = 0.276 and SEVR%, p = 0.583.