1. Implementation of a Brazilian Cardioprotective Nutritional (BALANCE) Program for improvement on quality of diet and secondary prevention of cardiovascular events: A randomized, multicenter trial
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Sende O. de Jesus, Fernanda C. Amparo, Marta M. David, Sara Bobadra, Lilian P.S. Costa, Keyla L.A.L. Deucher, Juliana D Oliveira, Izabele Vian, Janaina Maiana Abreu Barbosa, Karina C.S. Missias, Alexandre Biasi Cavalcanti, Luisa P. Silva, Lannay Ferreira da Silva, Andrea P. Galante, Adriana Barros Luna, Jâniffer R. Beiersdorf, Ângela Cristine Bersch-Ferreira, Diana S. Russo, Marilia C.S. Lucas, Maria Bárbara Galdino Silva, Monique T. de Jesus, Rosângela Maria Lopes de Sousa, Délcio G.S. Junior, Raquel Milani El Kik, Sandramara Sasso, Celme B.P. de Araújo, Nathalia P. Bachettini, Maria A. Moraes, Neuma M.F.S. Leda, Cristine E. Nunes, Bruna G. Machado, Rafael M. Soares, Salvador S. Ramos, Bianca A.S. de Oliveira, Rosa Bosquetti, Cristiano P. dos Santos, Franciane Silvana Formentini, Adriana O.L. Veríssimo, Rosielle Batista Ferreira, Clenise F. Dantas, Valdiana B. Vasconcelos, Maria Renata Aragão dos Santos, Ana Paula O. de Queirós, Edite M.V.M. C. de Araújo, Luciana Pereira Pinto Dias, Francisca Eugenia Zaina Nagano, Sandra Mary Lima Vasconcelos, Elaine de Fatima Adorne, Gabriela S. Shirmann, Celma M. Martins, Aldair S. Guterres, Ana Paula Silva Caldas, Marina Berbigier, Alessandra C. Caiado, Fernanda L. Chiesa, Laís N.P. Navarro, Vera Elizabeth Closs, Raira Pagano, Cristina H. Matos, Juliane A. Rodrigues, Luciana B. Gonçalves, Raphaela Costa Ferreira, Rosana P. Costa, Isa G. Rodrigues, Emílio Hideyuki Moriguchi, Rebecca O. Maquiné, Ana P.P.F. Carvalho, Daniela O. Peçanha, Alessandra Doumid Borges Pretto, Michelle R. Santos, Mirena Boklis, Celia R. Bittencourt, Eduardo P. Trescastro, Mariana E.P. Lima, Bruna L.P. Ribas, Adriana F. Teixeira, Marina T. Asoo, Maria I.S. Taboada, Otavio Berwanger, Karen B. Ruschel, Suzi H.A. de Araujo, Nilma F. Silva, Rodrigo Necchi, Camile S. Teixeira, Vanessa C.F.O. Fagundes, Glauber B. da Silva, Carine S.A. Ribeiro, Francisco A. Costa, Sônia L. Pinto, Helen Hermana Miranda Hermsdorff, Suzana A. da Silva, Bárbara Rafaela Santos da Rocha, Rosileide S. Torres, Cíntia L. Ambrozio, Renata Torres Abib Bertacco, Rosângela C.A. Cantanhede, Annie S.B. Moreira, Camila Dourado, Aline Marcadenti, Milena P. Rodrigues, Renata A. da Silva, Daniele M.O. Carlos, Cláudia Porto Sabino Pinho, Rita C.L. Duarte, Lilian Vivian, Eliane S. Dutra, Neyla E. Silva, Luciano M. Backes, Lívia M.A.J. Silva, Letícia S. Sabino, Júlia D. Lopes, Alexsandro Ferreira dos Santos, Lúcia H.A. Gratão, Paulo Victor Gomes Modanese, Cristina T. Telles, Juliana L. Pereira, Luciana V.S. Alves, Tainah S. Souza, Lúcia Rota Borges, Maria Cristina de Oliveira Izar, Priscila Moreira, Simone Raimondi de Souza, Priscila A. Rodrigues, Jorge L. Boemo, Deborah Marotto, Eduardo Gehling Bertoldi, Priccila Zuchinali, Jéssica Schiavini, Susi B. e Lima, Claiza Barretta, Jacqueline T. da Silva, Alexandre Gastaud, Daniela Rampazzo, Vera M.S. Bortonili, Laís B. da Costa, Luciana C. Holzbach, Sabrina A. Vieira, Maria E.M. Ramos, Waldemar de Carli, Magali C.C. Kumbier, Tamirys D. Sangali, Renato Hideo Nakagawa Santos, Elisa M. Santos, Roberta Mânica Cardoso, Simone M. Fischer, Marina K. Ito, Andreza M. Penafort, Naoel H. Feres, Bruno R.B. de Ataíde, Mihaela Onofrei, José Albuquerque de Figueiredo Neto, Camila R. Honório, Enilda de Sousa Lara, Catharina C.J. Paiva, Marina Shumacher, Gabriela C. Souza, Rafael L. Rech, Viviane Aparecida Rodrigues Sant'Anna, Antônio Carlos Sobral Sousa, Laura M. da Costa, André Eduardo da Silva Júnior, Luíza M. Garlini, Cintia G.N.C. Cordeiro, Rose M. Uehara, Karina G. dos Santos, Josilene Maria Ferreira Pinheiro, Natalia de Morais Cunha, Camila Ragne Torreglosa, Luis G.S. Mota, Valéria A. Machado, Geysa Maria Nogueira Farias, Auriene L. Medeiros, Amanda G.L. Coura, Kellen C. Silva, Karine Maria Moreira Almeida, Lívia A. Pellegrini, Luana R.M. Lima, Guilherme C.M. Bragança, Joise M. Teixeira, Aline Longo, Vanessa Bertoni, Cristiane Kovacs, Fernanda Vighi Dobke, Paula Souza, Alessandra da Silva, Elza C.B. Barbosa, Clarice M. Specht, Carlos D. Magnoni, Alechandra S. Napparo, Isadora Bianco Cardoso, Mônica L.P. de los Santos, Camila V.S. Souza, Jaqueline S.O. Vieira, Viviane O.G. Nascimento, Luisa F. Reis, Andrea F.R. Cardoso, Jadson M. Morais, Helen M.S. Carvalho, Ana L. Barreto, Lais S. de Paula, Aline S. Monteiro, Josiele Kesties, Ana C.L. Andrade, Juliana T. Kato, Bernardete Weber, Tatiana M.X. de Meneses, Priscila M. Pinho, Thiago T. de Freitas, Joyce Salamoni, Moacyr M. Palmeira, Malaine M.A. Machado, Bianca M. Fracasso, Viviane Sahade, Givaldo A. Araújo, Fernando G. Zampieri, Matheus Brum Felício, Soraia Poloni, Neide M. Bruscato, Caroline Frehner, Josefina Bressan, Andreza Santos Almeida, Socorro N.A.A. Barbosa, Helyde Albuquerque Marinho, Patrícia R.T. Martins, Maiara Cantarelli, and Monica Damiani
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Male ,Nutrition Education ,Body Mass ,National Health Programs ,030204 cardiovascular system & hematology ,Vegetable ,Procedures ,Prescription ,law.invention ,0302 clinical medicine ,Cerebrovascular Accident ,Randomized controlled trial ,law ,Risk Factors ,Cardiovascular Disease ,Cause of Death ,Clinical endpoint ,Whole Grain ,Secondary Prevention ,030212 general & internal medicine ,Myocardial infarction ,All Cause Mortality ,Amputation ,Program Development ,Stroke ,Sex Difference ,Alcohol Consumption ,Incidence (epidemiology) ,Incidence ,Unstable Angina Pectoris ,Middle Aged ,Clinical Trial ,Hospitalization ,Multicenter Study ,Survival Rate ,Practice Guideline ,Cardiovascular Diseases ,Randomized Controlled Trial ,Priority Journal ,Female ,Public Health ,Cardiology and Cardiovascular Medicine ,Brazil ,Human ,Adult ,medicine.medical_specialty ,Major Clinical Study ,Nutritional Status ,Follow Up ,03 medical and health sciences ,Age ,Cause Of Death ,Multicenter trial ,Internal medicine ,medicine ,Humans ,Controlled Study ,Nutritional Assessment ,Study Design ,Unstable angina ,business.industry ,Brasil ,Risk Factor ,medicine.disease ,Heart Infarction ,Heart Arrest ,Diet ,Blood pressure ,Nutrition Assessment ,Fruit ,Family Income ,business ,Cardiovascular Risk ,Diet Therapy ,Nutritional Counseling ,Total Quality Management - 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
- Published
- 2019