The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial)

This article reports the rationale for theBrazilianCardioprotectiveNutritional Program (BALANCEProgram) Trial. This pragmatic, multicenter, nationwide, randomized, concealed, controlled trial was designed to investigate the effects of the BALANCE Program in reducing cardiovascular events. The BALANCE Program consists of a prescribed diet guided by nutritional content recommendations from Brazilian national guidelines using a unique nutritional education strategy, which includes suggestions of affordable foods. Inaddition, theProgramfocuseson intensive follow-up throughone-on-onevisits, groupsessions,andphonecalls. In this trial, participants45yearsorolderwithanyevidenceofestablishedcardiovasculardiseasewill be randomized to theBALANCEorcontrolgroups. Those in the BALANCE group will receive the afore mentioned program interventions, while controls will be given generic advice on how to follow a low-fat, low-energy, low-sodium, and low-cholesterol diet, with a view to achieving Brazilian nutritional guideline recommendations. The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina. A total of 2468 patients will be enrolled in 34 sites and followed up for up to 48 months. If the BALANCE Program is found to decrease cardiovascular events and reduce risk factors, this may represent an advance in the care of patients with cardiovascular disease. (Am Heart J 2016;171:73-81.e2.) Cardiovascular disease (CVD) is the leading cause of death worldwide and in developing countries. In Brazil, despite a recent decline, cardiovascular mortality rates remain higher than in the majority of other South American, North American, and European countries. Randomized studies show that the Mediterranean diet is beneficial for patients with established CVD or at risk of CVD development. Indeed, the nutritional composition of the Mediterranean diet is one of the main references for dietary guidelines for treatment and prevention of CVD in Brazil and elsewhere. However, in many countries, including Brazil, most of the Mediterranean diet foods are not widely available, may be expensive, or are not part of local eating habits. Hence, prescription of a Mediterranean diet intervention for CVD to Brazilian populations may be infeasible and lead to low adherence. With a focus on the needs of the mostly low-income Brazilian population, a dietary and nutritional program that provides for these particularities has been developed. The Brazilian Cardioprotective Nutritional Program (BALANCE Program) takes into account access to food and understanding of the nutrition prescription, which have already been tested in a pilot study. The results showed that the standardized Program diet seems to be feasible and effective, promoting reductions in blood pressure, fasting glucose concentration, weight, and body mass index (BMI) in patients with established CVD. The BALANCE Program trial will investigate the effects of the Program on reducing cardiovascular events—such as cardiac arrest, acutemyocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, and hospitalization for unstable angina—or death in patients with established CVD.Moreover, it will evaluate the effects of the dietary program on reducing CV factors, such as BMI, waist circumference, blood pressure, total cholesterol, lowdensity lipoprotein, triglycerides, and fasting glucose.