Implementation of a Brazilian Cardioprotective Nutritional (BALANCE) Program for improvement on quality of diet and secondary prevention of cardiovascular events: A randomized, multicenter trial
Bernardete Weber, Ângela C Bersch-Ferreira, Camila R Torreglosa, Aline Marcadenti, Enilda S Lara, Jacqueline T da Silva, Rosana P Costa, Renato H N Santos, Otavio Berwanger, Rosa Bosquetti, Raira Pagano, Luis G S Mota, Juliana D de Oliveira, Rafael M Soares, Andrea P Galante, Suzana A da Silva, Fernando G Zampieri, Cristiane Kovacs, Fernanda C Amparo, Priscila Moreira, Renata A da Silva, Karina G Dos Santos, Aline S Monteiro, Catharina C J Paiva, Carlos D Magnoni, Annie S B Moreira, Daniela O Peçanha, Karina C S Missias, Lais S de Paula, Deborah Marotto, Paula Souza, Patrícia R T Martins, Elisa M Dos Santos, Michelle R Santos, Luisa P Silva, Rosileide S Torres, Socorro N A A Barbosa, Priscila M de Pinho, Suzi H A de Araujo, Adriana O L Veríssimo, Aldair S Guterres, Andrea F R Cardoso, Moacyr M Palmeira, Bruno R B de Ataíde, Lilian P S Costa, Helyde A Marinho, Celme B P de Araújo, Helen M S Carvalho, Rebecca O Maquiné, Alessandra C Caiado, Cristina H de Matos, Claiza Barretta, Clarice M Specht, Mihaela Onofrei, Renata T A Bertacco, Lucia R Borges, Eduardo G Bertoldi, Aline Longo, Bruna L P Ribas, Fernanda Dobke, Alessandra D B Pretto, Nathalia P Bachettini, Alexandre Gastaud, Rodrigo Necchi, Gabriela C Souza, Priccila Zuchinali, Bianca M Fracasso, Sara Bobadra, Tamirys D Sangali, Joyce Salamoni, Luíza M Garlini, Gabriela S Shirmann, Mônica L P de Los Santos, Vera M S Bortonili, Cristiano P Dos Santos, Guilherme C M Bragança, Cíntia L Ambrózio, Susi B E Lima, Jéssica Schiavini, Alechandra S Napparo, Jorge L Boemo, Francisca E Z Nagano, Paulo V G Modanese, Natalia M Cunha, Caroline Frehner, Lannay F da Silva, Franciane S Formentini, Maria E M Ramos, Salvador S Ramos, Marilia C S Lucas, Bruna G Machado, Karen B Ruschel, Jâniffer R Beiersdorf, Cristine E Nunes, Rafael L Rech, Mônica Damiani, Marina Berbigier, Soraia Poloni, Izabele Vian, Diana S Russo, Juliane A Rodrigues, Maria A P de Moraes, Laura M da Costa, Mirena Boklis, Raquel M El Kik, Elaine F Adorne, Joise M Teixeira, Eduardo P Trescastro, Fernanda L Chiesa, Cristina T Telles, Livia A Pellegrini, Luisa F Reis, Roberta G M Cardoso, Vera E Closs, Naoel H Feres, Nilma F da Silva, Neyla E Silva, Eliane S Dutra, Marina K Ito, Mariana E P Lima, Ana P P F Carvalho, Maria I S Taboada, Malaine M A Machado, Marta M David, Délcio G S Júnior, Camila Dourado, Vanessa C F O Fagundes, Rose M Uehara, Sandramara Sasso, Jaqueline S O Vieira, Bianca A S de Oliveira, Juliana L Pereira, Isa G Rodrigues, Claudia P S Pinho, Antonio C S Sousa, Andreza S Almeida, Monique T de Jesus, Glauber B da Silva, Luciana V S Alves, Viviane O G Nascimento, Sabrina A Vieira, Amanda G L Coura, Clenise F Dantas, Neuma M F S Leda, Auriene L Medeiros, Ana C L Andrade, Josilene M F Pinheiro, Luana R M de Lima, Letícia S Sabino, Camila V S de Souza, Sandra M L Vasconcelos, Francisco A Costa, Raphaela C Ferreira, Isadora B Cardoso, Laís N P Navarro, Rosielle B Ferreira, André E S Júnior, Maria B G Silva, Karine M M Almeida, Andreza M Penafort, Ana P O de Queirós, Geysa M N Farias, Daniele M O Carlos, Cíntia G N C Cordeiro, Valdiana B Vasconcelos, Edite M V M C de Araújo, Viviane Sahade, Carine S A Ribeiro, Givaldo A Araujo, Luciana B Gonçalves, Camile S Teixeira, Lívia M A J Silva, Laís B da Costa, Tainah S Souza, Sende O de Jesus, Adriana B Luna, Barbara R S da Rocha, Maria A Santos, José A F Neto, Luciana P P Dias, Rosângela C A Cantanhede, Jadson M Morais, Rita C L Duarte, Elza C B Barbosa, Janaina M A Barbosa, Rosângela M L de Sousa, Alexsandro F Dos Santos, Adriana F Teixeira, Emilio H Moriguchi, Neide M Bruscato, Josiele Kesties, Lilian Vivian, Waldemar de Carli, Marina Shumacher, Maria C O Izar, Marina T Asoo, Juliana T Kato, Celma M Martins, Valéria A Machado, Célia R O Bittencourt, Thiago T de Freitas, Viviane A R Sant'Anna, Júlia D Lopes, Simone C P M Fischer, Sônia L Pinto, Kellen C Silva, Lúcia H A Gratão, Luciana C Holzbach, Luciano M Backes, Milena P Rodrigues, Keyla L A L Deucher, Maiara Cantarelli, Vanessa M Bertoni, Daniela Rampazzo, Josefina Bressan, Helen H M Hermsdorff, Ana P S Caldas, Matheus B Felício, Camila R Honório, Alessandra da Silva, Simone R Souza, Priscila A Rodrigues, Tatiana M X de Meneses, Magali C C Kumbier, Ana L Barreto, Alexandre B Cavalcanti, Bernardete Weber, Ângela C Bersch-Ferreira, Camila R Torreglosa, Aline Marcadenti, Enilda S Lara, Jacqueline T da Silva, Rosana P Costa, Renato H N Santos, Otavio Berwanger, Rosa Bosquetti, Raira Pagano, Luis G S Mota, Juliana D de Oliveira, Rafael M Soares, Andrea P Galante, Suzana A da Silva, Fernando G Zampieri, Cristiane Kovacs, Fernanda C Amparo, Priscila Moreira, Renata A da Silva, Karina G Dos Santos, Aline S Monteiro, Catharina C J Paiva, Carlos D Magnoni, Annie S B Moreira, Daniela O Peçanha, Karina C S Missias, Lais S de Paula, Deborah Marotto, Paula Souza, Patrícia R T Martins, Elisa M Dos Santos, Michelle R Santos, Luisa P Silva, Rosileide S Torres, Socorro N A A Barbosa, Priscila M de Pinho, Suzi H A de Araujo, Adriana O L Veríssimo, Aldair S Guterres, Andrea F R Cardoso, Moacyr M Palmeira, Bruno R B de Ataíde, Lilian P S Costa, Helyde A Marinho, Celme B P de Araújo, Helen M S Carvalho, Rebecca O Maquiné, Alessandra C Caiado, Cristina H de Matos, Claiza Barretta, Clarice M Specht, Mihaela Onofrei, Renata T A Bertacco, Lucia R Borges, Eduardo G Bertoldi, Aline Longo, Bruna L P Ribas, Fernanda Dobke, Alessandra D B Pretto, Nathalia P Bachettini, Alexandre Gastaud, Rodrigo Necchi, Gabriela C Souza, Priccila Zuchinali, Bianca M Fracasso, Sara Bobadra, Tamirys D Sangali, Joyce Salamoni, Luíza M Garlini, Gabriela S Shirmann, Mônica L P de Los Santos, Vera M S Bortonili, Cristiano P Dos Santos, Guilherme C M Bragança, Cíntia L Ambrózio, Susi B E Lima, Jéssica Schiavini, Alechandra S Napparo, Jorge L Boemo, Francisca E Z Nagano, Paulo V G Modanese, Natalia M Cunha, Caroline Frehner, Lannay F da Silva, Franciane S Formentini, Maria E M Ramos, Salvador S Ramos, Marilia C S Lucas, Bruna G Machado, Karen B Ruschel, Jâniffer R Beiersdorf, Cristine E Nunes, Rafael L Rech, Mônica Damiani, Marina Berbigier, Soraia Poloni, Izabele Vian, Diana S Russo, Juliane A Rodrigues, Maria A P de Moraes, Laura M da Costa, Mirena Boklis, Raquel M El Kik, Elaine F Adorne, Joise M Teixeira, Eduardo P Trescastro, Fernanda L Chiesa, Cristina T Telles, Livia A Pellegrini, Luisa F Reis, Roberta G M Cardoso, Vera E Closs, Naoel H Feres, Nilma F da Silva, Neyla E Silva, Eliane S Dutra, Marina K Ito, Mariana E P Lima, Ana P P F Carvalho, Maria I S Taboada, Malaine M A Machado, Marta M David, Délcio G S Júnior, Camila Dourado, Vanessa C F O Fagundes, Rose M Uehara, Sandramara Sasso, Jaqueline S O Vieira, Bianca A S de Oliveira, Juliana L Pereira, Isa G Rodrigues, Claudia P S Pinho, Antonio C S Sousa, Andreza S Almeida, Monique T de Jesus, Glauber B da Silva, Luciana V S Alves, Viviane O G Nascimento, Sabrina A Vieira, Amanda G L Coura, Clenise F Dantas, Neuma M F S Leda, Auriene L Medeiros, Ana C L Andrade, Josilene M F Pinheiro, Luana R M de Lima, Letícia S Sabino, Camila V S de Souza, Sandra M L Vasconcelos, Francisco A Costa, Raphaela C Ferreira, Isadora B Cardoso, Laís N P Navarro, Rosielle B Ferreira, André E S Júnior, Maria B G Silva, Karine M M Almeida, Andreza M Penafort, Ana P O de Queirós, Geysa M N Farias, Daniele M O Carlos, Cíntia G N C Cordeiro, Valdiana B Vasconcelos, Edite M V M C de Araújo, Viviane Sahade, Carine S A Ribeiro, Givaldo A Araujo, Luciana B Gonçalves, Camile S Teixeira, Lívia M A J Silva, Laís B da Costa, Tainah S Souza, Sende O de Jesus, Adriana B Luna, Barbara R S da Rocha, Maria A Santos, José A F Neto, Luciana P P Dias, Rosângela C A Cantanhede, Jadson M Morais, Rita C L Duarte, Elza C B Barbosa, Janaina M A Barbosa, Rosângela M L de Sousa, Alexsandro F Dos Santos, Adriana F Teixeira, Emilio H Moriguchi, Neide M Bruscato, Josiele Kesties, Lilian Vivian, Waldemar de Carli, Marina Shumacher, Maria C O Izar, Marina T Asoo, Juliana T Kato, Celma M Martins, Valéria A Machado, Célia R O Bittencourt, Thiago T de Freitas, Viviane A R Sant'Anna, Júlia D Lopes, Simone C P M Fischer, Sônia L Pinto, Kellen C Silva, Lúcia H A Gratão, Luciana C Holzbach, Luciano M Backes, Milena P Rodrigues, Keyla L A L Deucher, Maiara Cantarelli, Vanessa M Bertoni, Daniela Rampazzo, Josefina Bressan, Helen H M Hermsdorff, Ana P S Caldas, Matheus B Felício, Camila R Honório, Alessandra da Silva, Simone R Souza, Priscila A Rodrigues, Tatiana M X de Meneses, Magali C C Kumbier, Ana L Barreto, Alexandre B Cavalcanti
Abstract
Background: Appropriate dietary recommendations represent a key part of secondary prevention in cardiovascular disease (CVD). We evaluated the effectiveness of the implementation of a nutritional program on quality of diet, cardiovascular events, and death in patients with established CVD.
Methods: In this open-label, multicenter 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 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. 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 the BALANCE Program group (n = 1,266) or the control group (n = 1,268) 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 modified Alternative Healthy Eating Index (scale 0-70) was only slightly higher in the BALANCE group versus the control group (26.2 ± 8.4 vs 24.7 ± 8.6, P < .01), mainly due to a 0.5-serving/d greater intake of fruits and of vegetables in the BALANCE group. Primary end point events occurred in 236 participants (18.8%) in the BALANCE group and in 207 participants (16.4%) in the control group (hazard ratio, 1.15; 95% CI 0.95-1.38; 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.
Trial registration: ClinicalTrials.gov NCT01620398.
Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed