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BIBTEX RIS

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

2015; Elsevier BV; Volume: 171; Issue: 1 Linguagem: Inglês

10.1016/j.ahj.2015.08.010

1097-6744

Bernardete Weber, Ângela Cristine Bersch-Ferreira, Camila Ragne Torreglosa, Maria Beatriz Ross-Fernandes, Jacqueline T. da Silva, Andrea Galante, Enilda de Sousa Lara, Rosana Perim Costa, Rafael Marques Soares, Alexandre Biasi Cavalcanti, Emílio Hideyuki Moriguchi, Neide Maria Bruscato, Josiele Kesties, Lilian Vivian, Marina Schumacher, Waldemar de Carli, Luciano Marcelo Backes, Bruna R. Reolão, Milena P. Rodrigues, Dúnnia M.B. Baldissera, Glaucia S. Tres, Hugo Lisboa, João B.J., José Basileu Caon Reolão, Keyla L.A.L. Deucher, Maiara Cantarelli, Aline Lucion, Daniela Rampazzo, Vanessa Maria Bertoni, Rosileide S. Torres, Adriana O.L. Verríssimo, Aldair S. Guterres, Andrea F.R. Cardos, Dalva B.S. Coutinho, Mayara Galisse NEGRÃO, Mônica F.A. Alencar, Priscila Matos de Pinho Costa, Socorro Nazaré Araújo Almeida Barbosa, Ana P.P.F. Carvalho, Maria I.S. Taboada, Sheila Alves Pereira, Raul von der Heyde, Francisca Eugênia Zaina Nagano, Rebecca Baumgartner, Fernanda P. Resende, Ranata Tabalipa, Ana C. Zanini, Michael J.R. Machado, Hevila Araujo, Maria Laura Verissimo Teixeira, Gabriela Corrêa Souza, Priccila Zuchinali, Bianca M. Fracasso, Karen Ulliam, Marina Schumacher, Moara Pierotto, Thamires de Souza Hilário, Daniele M.O. Carlos, Cíntia G.N.C. Cordeiro, D. De Carvalho, Marília S. Gonçalves, Valdiana B. Vasconcelos, Rosa Bosquetti, Raira Pagano, Marcelo Luz Pereira Romano, César Jardim, Bernardo Noya Alves de Abreu, Aline Marcadenti, Alessandra R. Schmitt, Ângela Maria Vicente Tavares, Christiane Carvalho Faria, Flávia Moraes Silva, Jaqueline da Silva Fink, Raquel Milani El Kik, Clarice F. Prates, Cristiane S. Vieira, Elaine F. Adorne, Ellen Hettwer Magedanz, Fernanda Lourega Chieza, Ingrid S. Silva, Joise M. Teixeira, Eduardo P. Trescastro, Livia Pellegrini, Jéssika Cefrin Dantas Neris, Cristina T. Telles, Antônio Carlos Sobral Sousa, Andreza Santos Almeida, Ariane A. Costa, José A.C. Carmo, Juliana T. Silva, Luciana Vieira Sousa Alves, Saulo Sales, María Elena Ramos, Marilia C.S. Lucas, Mônica Damiani, Patrícia Cristina Cardoso, Salvador S. Ramos, Clenise F. Dantas, Amanda Lopes, Ana M.P. Cabral, Ana C.A. Lucena, Auriene L. Medeiros, Bernardino B. Terceiro, Neuma M.F.S. Leda, Sandra R.D. Baía, Josilene Maria Ferreira Pinheiro, Alexandra N. Cassiano, Andressa N.L. Melo, Anny K.O. Cavalcanti, Camila V.S. Souza, Dayanna Joyce Marques Queiroz, Hercilla N.C.F. Farias, Larissa Camila Ferreira Souza, Letícia Sabino Santos, Luana R.M. Lima, Meg S. Hoffmann, Átala Safira Silva Ribeiro, Daniel França Vasconcelos, Eliane Said Dutra, Marina Ito, José Albuquerque de Figueiredo Neto, Alexsandro F. Santos, Rosângela Maria Lopes de Sousa, Luciana Pereira Pinto Dias, Maria Tereza Medeiros Aureliano de Lima, Victor G. Modanesi, Adriana Fonseca Teixeira, Luciana C.N.C.D. Estrada, Paulo Victor Gomes Modanêsi, Adriana Barros Gomes, Bárbara Rafaela Santos da Rocha, Cristina Teti, Marta M. David, Bruna M. Palácio, Délcio G.S., Érica H.S. Faria, Michelle C.F. Oliveira, Rose Mary Uehara, Sandramara Sasso, Annie Seixas Bello Moreira, Ana C.A.H. Cadinha, Carla W.M. Pinto, Mariana P. Castilhos, Mariana Fernandes Costa, Cristiane Kovacs, Daniel Magnoni, Quênia Silva, Michele F.C.A. Germini, Renata A. da Silva, Aline S. Monteiro, Karina Gama dos Santos, Priscila Moreira, Fernanda C. Amparo, Catharina C.J. Paiva, Soraia Poloni, Diana S. Russo, Izabele V. Silveira, Maria Antonieta Moraes, Mirena Boklis, Quinto I. Cardoso, Annie Seixas Bello Moreira, Aline M.S. Damaceno, Elisa Maia dos Santos, Glauber Monteiro Dias, Cláudia Porto Sabino Pinho, Adrilene C. Cavalcanti, Amanda Silva de Macêdo Bezerra, Andrey Vieira de Queiroga, Isa Galvão Rodrigues, Tallita V. Leal, Viviane Sahade, Daniele A. Amaral, Diana S. Souza, Givaldo A. Araújo, Karine Duarte Curvello, Manuella Heine, Marília M.S. Barretto, Nailson A. Reis, Sandra Mary Lima Vasconcelos, Danielly C. Vieira, Francisco A. Costa, Jessica M.S. Fontes, Juvenal G.C. Neto, Laís Nanci Pereira Navarro, Raphaela Costa Ferreira, Patrícia de Menezes Marinho, Renata Torres Abib, Aline Longo, Eduardo Gehling Bertoldi, Lauren S. Ferreira, Lúcia Rota Borges, Norlai Alves Azevedo, Celma M. Martins, Juliana T. Kato, Maria Cristina de Oliveira Izar, Marina T. Asoo, Mariana Dutilh de Capitani, Valéria A. Machado, Waléria T. Fonzar, Sônia Lopes Pinto, Kellen C. Silva, Lúcia Helena Almeida Gratão, Sheila D. Machado, Susane R.U. de Oliveira, Josefina Bressan, Ana Paula Silva Caldas, Hatanne Carla Fialho Moraes Lima, Helen Hermana Miranda Hermsdorff, Tânia M. Saldanha, Sílvia Eloiza Priore, Naoel H. Feres, Adila de Queiroz Neves, Loanda Maria Gomes Cheim, Nilma F. Silva, Sílvia R.L. Reis, Andreza M. Penafort, Ana Paula O. de Queirós, Geysa Maria Nogueira Farias, Mônica Lourdes Palomino de los Santos, Cíntia L. Ambrózio, Cirília N. Camejo, Cristiano P. dos Santos, Gabriela da Silva Schirmann, Jorge L. Boemo, Rosane E.C. Oliveira, Súsi M.B. Lima, Vera M.S. Bortolini, Cristina Matos, Claiza Barretta, Clarice Maria Specht, Simone Raimondi de Souza, Cristina Silva Arruda, Priscila Aparecida Rodrigues, Otávio Berwanger,

Diet and metabolism studies

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.