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Randomized Controlled Trial
. 2019 Sep:215:187-197.
doi: 10.1016/j.ahj.2019.06.010. Epub 2019 Jun 21.

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  1 , Ângela C Bersch-Ferreira  2 , Camila R Torreglosa  3 , Aline Marcadenti  4 , Enilda S Lara  2 , Jacqueline T da Silva  2 , Rosana P Costa  2 , Renato H N Santos  2 , Otavio Berwanger  2 , Rosa Bosquetti  2 , Raira Pagano  2 , Luis G S Mota  2 , Juliana D de Oliveira  2 , Rafael M Soares  2 , Andrea P Galante  2 , Suzana A da Silva  2 , Fernando G Zampieri  2 , Cristiane Kovacs  5 , Fernanda C Amparo  5 , Priscila Moreira  5 , Renata A da Silva  5 , Karina G Dos Santos  5 , Aline S Monteiro  5 , Catharina C J Paiva  5 , Carlos D Magnoni  5 , Annie S B Moreira  6 , Daniela O Peçanha  7 , Karina C S Missias  7 , Lais S de Paula  7 , Deborah Marotto  7 , Paula Souza  8 , Patrícia R T Martins  8 , Elisa M Dos Santos  8 , Michelle R Santos  8 , Luisa P Silva  8 , Rosileide S Torres  9 , Socorro N A A Barbosa  9 , Priscila M de Pinho  9 , Suzi H A de Araujo  9 , Adriana O L Veríssimo  9 , Aldair S Guterres  9 , Andrea F R Cardoso  9 , Moacyr M Palmeira  9 , Bruno R B de Ataíde  9 , Lilian P S Costa  9 , Helyde A Marinho  10 , Celme B P de Araújo  10 , Helen M S Carvalho  10 , Rebecca O Maquiné  10 , Alessandra C Caiado  10 , Cristina H de Matos  11 , Claiza Barretta  11 , Clarice M Specht  11 , Mihaela Onofrei  11 , Renata T A Bertacco  12 , Lucia R Borges  12 , Eduardo G Bertoldi  12 , Aline Longo  12 , Bruna L P Ribas  12 , Fernanda Dobke  12 , Alessandra D B Pretto  12 , Nathalia P Bachettini  12 , Alexandre Gastaud  12 , Rodrigo Necchi  12 , Gabriela C Souza  13 , Priccila Zuchinali  13 , Bianca M Fracasso  13 , Sara Bobadra  13 , Tamirys D Sangali  13 , Joyce Salamoni  13 , Luíza M Garlini  13 , Gabriela S Shirmann  14 , Mônica L P de Los Santos  14 , Vera M S Bortonili  14 , Cristiano P Dos Santos  14 , Guilherme C M Bragança  14 , Cíntia L Ambrózio  14 , Susi B E Lima  14 , Jéssica Schiavini  14 , Alechandra S Napparo  14 , Jorge L Boemo  14 , Francisca E Z Nagano  15 , Paulo V G Modanese  15 , Natalia M Cunha  15 , Caroline Frehner  15 , Lannay F da Silva  15 , Franciane S Formentini  15 , Maria E M Ramos  16 , Salvador S Ramos  16 , Marilia C S Lucas  16 , Bruna G Machado  16 , Karen B Ruschel  16 , Jâniffer R Beiersdorf  16 , Cristine E Nunes  16 , Rafael L Rech  16 , Mônica Damiani  16 , Marina Berbigier  16 , Soraia Poloni  17 , Izabele Vian  17 , Diana S Russo  17 , Juliane A Rodrigues  17 , Maria A P de Moraes  17 , Laura M da Costa  17 , Mirena Boklis  17 , Raquel M El Kik  18 , Elaine F Adorne  18 , Joise M Teixeira  18 , Eduardo P Trescastro  18 , Fernanda L Chiesa  18 , Cristina T Telles  18 , Livia A Pellegrini  18 , Luisa F Reis  18 , Roberta G M Cardoso  18 , Vera E Closs  18 , Naoel H Feres  19 , Nilma F da Silva  19 , Neyla E Silva  19 , Eliane S Dutra  20 , Marina K Ito  20 , Mariana E P Lima  20 , Ana P P F Carvalho  21 , Maria I S Taboada  21 , Malaine M A Machado  21 , Marta M David  22 , Délcio G S Júnior  22 , Camila Dourado  22 , Vanessa C F O Fagundes  22 , Rose M Uehara  22 , Sandramara Sasso  22 , Jaqueline S O Vieira  22 , Bianca A S de Oliveira  22 , Juliana L Pereira  22 , Isa G Rodrigues  23 , Claudia P S Pinho  23 , Antonio C S Sousa  24 , Andreza S Almeida  24 , Monique T de Jesus  24 , Glauber B da Silva  24 , Luciana V S Alves  24 , Viviane O G Nascimento  24 , Sabrina A Vieira  24 , Amanda G L Coura  25 , Clenise F Dantas  25 , Neuma M F S Leda  25 , Auriene L Medeiros  25 , Ana C L Andrade  25 , Josilene M F Pinheiro  26 , Luana R M de Lima  26 , Letícia S Sabino  26 , Camila V S de Souza  26 , Sandra M L Vasconcelos  27 , Francisco A Costa  27 , Raphaela C Ferreira  27 , Isadora B Cardoso  27 , Laís N P Navarro  27 , Rosielle B Ferreira  27 , André E S Júnior  27 , Maria B G Silva  27 , Karine M M Almeida  27 , Andreza M Penafort  28 , Ana P O de Queirós  28 , Geysa M N Farias  28 , Daniele M O Carlos  29 , Cíntia G N C Cordeiro  29 , Valdiana B Vasconcelos  29 , Edite M V M C de Araújo  29 , Viviane Sahade  30 , Carine S A Ribeiro  30 , Givaldo A Araujo  30 , Luciana B Gonçalves  30 , Camile S Teixeira  30 , Lívia M A J Silva  30 , Laís B da Costa  30 , Tainah S Souza  30 , Sende O de Jesus  30 , Adriana B Luna  31 , Barbara R S da Rocha  31 , Maria A Santos  31 , José A F Neto  32 , Luciana P P Dias  32 , Rosângela C A Cantanhede  32 , Jadson M Morais  32 , Rita C L Duarte  32 , Elza C B Barbosa  32 , Janaina M A Barbosa  32 , Rosângela M L de Sousa  32 , Alexsandro F Dos Santos  32 , Adriana F Teixeira  32 , Emilio H Moriguchi  33 , Neide M Bruscato  33 , Josiele Kesties  33 , Lilian Vivian  33 , Waldemar de Carli  33 , Marina Shumacher  33 , Maria C O Izar  34 , Marina T Asoo  34 , Juliana T Kato  34 , Celma M Martins  34 , Valéria A Machado  34 , Célia R O Bittencourt  34 , Thiago T de Freitas  34 , Viviane A R Sant'Anna  34 , Júlia D Lopes  34 , Simone C P M Fischer  34 , Sônia L Pinto  35 , Kellen C Silva  35 , Lúcia H A Gratão  35 , Luciana C Holzbach  35 , Luciano M Backes  36 , Milena P Rodrigues  36 , Keyla L A L Deucher  36 , Maiara Cantarelli  36 , Vanessa M Bertoni  36 , Daniela Rampazzo  36 , Josefina Bressan  37 , Helen H M Hermsdorff  37 , Ana P S Caldas  37 , Matheus B Felício  37 , Camila R Honório  37 , Alessandra da Silva  37 , Simone R Souza  38 , Priscila A Rodrigues  38 , Tatiana M X de Meneses  38 , Magali C C Kumbier  39 , Ana L Barreto  39 , Alexandre B Cavalcanti  2
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Free article
Randomized Controlled Trial

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 et al. Am Heart J. 2019 Sep.
Free article

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.

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