Implementation of a Brazilian Cardioprotective nutritional (BALANCE) program for improvement on quality of diet and secondary prevention of cardiovascular events: A randomized, multicentre trial

Abstract Background Appropriate dietary recommendations represent a key part of secondary prevention in cardiovascular disease (CVD). Objective We evaluated the effectiveness of the implementation of a nutritional program on quality of diet, cardiovascular events and death in patients with established CVD. Design In this open-label, multicentre trial conducted in 35 sites in Brazil, we randomly assigned (1:1) patients aged 45 years or older to receive either the BALANCE Program (experimental group) or to receive conventional nutrition advice (control group). The BALANCE Program included a unique nutritional education strategy to implement recommendations from guidelines, adapted to the use of affordable and regional foods. Adherence to diet was evaluated by the modified Alternative Healthy Eating Index (mAHEI). The primary end point was a composite of all-cause mortality, cardiovascular death, cardiac arrest, myocardial infarction, stroke, myocardial revascularization, amputation, or hospitalization for unstable angina. Secondary end points included biochemical and anthropometric data, and blood pressure levels. Results From March 5, 2013, to Abril 7, 2015, a total of 2534 eligible patients were randomly assigned to either BALANCE Program group (n = 1266) or to the control group (n = 1268), and were followed-up for a median of 3.5 years. In total, 235 (9.3%) participants had been lost to follow-up. After 3 years of follow-up, mean mAHEI (scale 0–70) was only slightly higher in the BALANCE group vs. the control group (26.2 ± 8.4 vs. 24.7 ± 8.6 P P  = .15). Secondary end points did not differ between groups after follow-up. Conclusions The BALANCE Program only slightly improved adherence to a healthy diet in patients with established CVD, and had no significant effect on the incidence of cardiovascular events or death.