학술논문
The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial)
Document Type
Academic Journal
Author
Weber, Bernardete; Bersch-Ferreira, Ângela Cristine; Torreglosa, Camila Ragne; Ross-Fernandes, Maria Beatriz; da Silva, Jacqueline Tereza; Galante, Andrea Polo; de Sousa Lara, Enilda; Costa, Rosana Perim; Soares, Rafael Marques; Cavalcanti, Alexandre Biasi; Berwanger, Otávio; Bersch-Ferreira, Ângela C; Torreglosa, Camila Re; Silva, Jacqueline T.; Ross-Fernandes, Maria B.; Soares, Rafael M.; Weber, Bernardete; Galante, Andrea P; Sousa, Enilda L; Costa, Rosana P; Berwanger, Otávio; Silva, Jacqueline T; Ross-Fernandes, Maria B; Pereira, Sabrina B; Ikeoka, Dimas T; Silva, Suzana A; Moriguchi, Emilio H; Kesties, Josiele; Vivian, Lilian; Schumacher, Marina; Bruscato, Neide Maria; de Carli, Waldemar; Backes, Luciano M; Reolão, Bruna R; Tres, Glaucia S; Lisboa, Hugo RK; Bem, João BJ; Reolão, Jose BC; Deucher, Keyla LAL; Rodrigues, Milena P; Torres, Rosileide S; Verríssimo, Adriana OL; Guterres, Aldair S; Cardos, Andrea FR; Coutinho, Dalva BS; Negrão, Mayara G; Alencar, Mônica FA; Pinho, Priscila M; Barbosa, Socorro N; Carvalho, Ana PPF; Taboada, Maria IS; Pereira, Sheila A; Heyde, Raul V; Resende, Fernanda P; Zaina, Francisca E; Araujo, Hevila; Teixeira, Maria LV; Machado, Michael JR; Baumgartner, Rebecca; Souza, Gabriela; Fracasso, Bianca; Ulliam, Karen; Pierotto, Moara; Zuchinali, Priccila; Hilário, Thamires; Carlos, Daniele MO; Cordeiro, Cintia GNC; Carvalho, Daniele A; Gonçalves, Marília S; Barbosa, Valdiana; Torreglosa, Camila; Bosquetti, Rosa; Romano, Marcelo LP; Jardim, César A; de Abreu, Bernardo NA; Oliveira, Aline M; Schmitt, Alessandra R; Tavares, Ângela MV; Faria, Christiane C; Silva, Flávia M; Fink, Jaqueline S; El Kik, Raquel M; Prates, Clarice F; Vieira, Cristiane S; Adorne, Elaine F; Magedanz, Ellen H; Chieza, Fernanda L; Silva, Ingrid S; Teixeira, Joise M; Sousa, Antonio CS; Almeida, Andreza S; Costa, Ariane A; Carmo, José AC; Silva, Juliana T; Alves, Luciana VS; Sales, Saulo OC; Ramos, Maria EM; Lucas, Marilia CS; Damiani, Monica; Cardoso, Patricia C; Ramos, Salvador S; Dantas, Clenise F; Lopes, Amanda G; Cabral, Ana MP; Lucena, Ana CA; Medeiros, Auriene L; Terceiro, Bernardino B; Leda, Neuma MFS; Baía, Sandra RD; Pinheiro, Josilene MF; Cassiano, Alexandra N; Melo, Andressa NL; Cavalcanti, Anny KO; Souza, Camila WS; Queiroz, Dayanna JM; Farias, Hercilla NCF; Souza, Larissa CF; Santos, Letícia S; Lima, Luana RM; Hoffmann, Meg S; Silva Ribeiro, Átala S; Vasconcelos, Daniel F; Dutra, Eliane S; Ito, Marina K; Neto, José F; Santos, Alexsandro F; Sousa, Rosângela Maria L; Dias, Luciana Pereira P; Lima, Maria TMA; Modanesi, Victor G; Teixeira, Adriana F; Gomes, Adriana BL; Rocha, Bárbara; Teti, Crisitna; David, Marta M; Junior, Délcio GS; Faria, Érica HS; Oliveira, Michelle CF; Sasso, Sandramara; Moreira, Annie SB; Cadinha, Ana CAH; Pisuto, Carla WM; Castilhos, Mariana P; Magnoni, Carlos D; Kovacs, Cristiane; Silva, Quênia; Germini, Michele FCA; Alves, Renata; Polini, Soraia; Russo, Diana S; Silveira, Izabele V; Moraes, Maria A; Boklis, Mirena; Cardoso, Quinto I; Damaceno, Aline MS; Santos, Elisa M; Dias, Glauber M; Pinho, Cláudia PS; Cavalcanti, Adrilene C; Bezerra, Amanda S; Queiroga, Andrey V; Rodrigues, Isa G; Leal, Tallita V; Sahade, Viviane; Amaral, Daniele A; Souza, Diana S; Araújo, Givaldo A; Curvello, Karine; Heine, Manuella; Barretto, Marília MS; Reis, Nailson A; Vasconcelos, Sandra M; Vieira, Danielly C; Costa, Francisco A; Fontes, Jessica MS; Neto, Juvenal GC; Navarro, Laís NP; Ferreira, Raphaela C; Marinho, Patrícia M; Abib, Renata Torres; Longo, Aline; Bertoldi, Eduardo G; Ferreira, Lauren S; Borges, Lúcia R; Azevedo, Norlai A; Martins, Celma M; Kabo, Juliana T; Izar, Maria CO; Capitani, Mariana; Machado, Valéria A; Fronzar, Waléria T; Pinto, Sônia L; Silva, Kellen C; Gratão, Lúcia HA; Machado, Sheila D; Oliveira, Susane RU; Bressan, Josefina; Caldas, Ana PS; Lima, Hatanne CFM; Hermsdorff, Helen HM; Saldanha, Tânia M; Priore, Sílvia E; Feres, Naoel H; Queiroz, Ádila; Cheim, Loanda MG; Silva, Nilma F; Reis, Silvia RL; Santos, Mônica LP; Ambrózio, Cíntia L; Camejo, Cirília N; Santos, Cristiano P; Schirmann, Gabriela S; Boemo, Jorge L; Scardoelli, Paola R; Oliveira, Rosane EC; Lima, Súsi MB; Bortolini, Vera MS; Matos, Cristina H; Barretta, Claiza; Specht, Clarice M; de Souza, SimoneRaimondi; Arruda, Cristina; Rodrigues, Priscila Alves
Source
American Heart Journal. Jan 01, 2016 171(1):73-81e2
Subject
Language
English
ISSN
0002-8703
Abstract
ABSTRACT: This article reports the rationale for the Brazilian Cardioprotective Nutritional Program (BALANCE Program) 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. In addition, the Program focuses on intensive follow-up through one-on-one visits, group sessions, and phone calls. In this trial, participants 45 years or older with any evidence of established cardiovascular disease will be randomized to the BALANCE or control groups. 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.