Combined use of a healthy lifestyle smartphone application and usual primary care counseling to improve arterial stiffness, blood pressure and wave reflections: a Randomized Controlled Trial (EVIDENT II Study).

Our aim was to investigate the effects of an intervention that comprised a brief counseling session on lifestyle habits together with the use of the EVIDENT (Lifestyles and arterial aging) application on the modification of markers that indicated different hemodynamic functions, such as arterial stiffness, blood pressure or wave reflections. The EVIDENT II study (Lifestyles and arterial aging) is a randomized clinical trial with two parallel groups. Each participant had an initial visit and two follow-up visits at 3 and 12 months where the peripheral augmentation index-PAIx75 was measured by tonometry, while an oscillometric method was used for the cardio-ankle vascular index-CAVI and brachial-ankle pulse wave velocity-baPWV. Both groups (intervention-IG and control-CG) were briefly counseled on diet and exercise. The IG also received instructions on the use of the EVIDENT II application during the 3 months. The sample (N = 597; 52 ± 11 years; 64% women) was randomized into IG = 291 and CG = 306. Comparing groups, there was a decrease in the PAIx75 favorable to the IG at 3 months (-4.9%, 95% CI: -7.7 to -2.1) and 12 months (-3.9%, 95% CI: -6.8 to -1.0). There was also a nonsignificant reduction of the CAVI at 3 months in the IG. A group effect was observed in the measurement of the PAIx75 over the 12-month follow-up (p = 0.003). This interaction was only observed in women (p = 0.017). In conclusion, the use of the EVIDENT II application achieved a modification of the PAIx75, a marker of wave reflection and vascular tone, in women through lifestyle improvements (physical activity and adherence to the Mediterranean diet). No significant results were found regarding blood pressure or arterial stiffness markers.

RCT Entities:   Population Interventions Outcomes