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

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• 作者：Bernardete Weber ; CN ; PhD ; ^{bweber@hcor.com.br" class="auth_mail" title="E-mail the corresponding author} ; Â ; ngela Cristine Bersch-Ferreira ; CN ; MS ; Camila Ragne Torreglosa ; CN ; MS ; Maria Beatriz Ross-Fernandes ; CN ; Jacqueline Tereza da Silva ; CN ; Andrea Polo Galante ; CN ; PhD ; Enilda de Sousa Lara ; CN ; PhD ; Rosana Perim Costa ; CN ; MS ; Rafael Marques Soares ; CN ; MS ; Alexandre Biasi Cavalcanti ; MD ; PhD ; Otá ; vio Berwanger ; MD ; PhD ; on behalf of the BALANCE Program Trial investigators The BALANCE Investigators consist of ; Coordinating Center ; Â ; ngela C Bersch-Ferreira ; Camila Re Torreglosa ; Jacqueline T. Silva ; Maria B. Ross-Fernandes ; Rafael M. Soares ; Steering Committee ; Bernardete Weber ; Andrea P Galante ; Enilda L Sousa ; Rosana P Costa ; Otá ; vio Berwanger ; Data Monitoring Committee (not independent) ; Â ; ngela C Bersch-Ferreira ; Camila Re Torreglosa ; Jacqueline T Silva ; Maria B Ross-Fernandes ; Endpoint Adjudication Committee ; Sabrina B Pereira ; Dimas T Ikeoka ; Suzana A Silva ; Trial Centers ; Associaç ; ã ; o Veranense de Assistê ; ncia em Sa&uacute ; de (AVAES) ; Veranó ; polis-RS ; Emilio H Moriguchi (PI) ; Josiele Kesties ; Lilian Vivian ; Marina Schumacher ; Neide Maria Bruscato ; Waldemar de Carli ; BIOSERV ; Passo Fundo-RS ; Luciano M Backes (PI) ; Bruna R Reolã ; o ; Glaucia S Tres ; Hugo RK Lisboa ; Joã ; o BJ Bem ; Jose BC Reolã ; o ; Keyla LAL Deucher ; Milena P Rodrigues ; Hospital das Clí ; nicas Gaspar Viana ; Belé ; m-PA ; Rosileide S Torres (PI) ; Adriana OL Verrí ; ssimo ; Aldair S Guterres ; Andrea FR Cardos ; Dalva BS Coutinho ; Mayara G Negrã ; o ; Mô ; nica FA Alencar ; Priscila M Pinho ; Socorro N Barbosa ; Hospital das Clí ; nicas de Goiâ ; nia ; Goiâ ; nia-GO ; Ana PPF Carvalho (PI) ; Maria IS Taboada ; Sheila A Pereira ; Hospital de Clí ; nicas da Universidade Federal do Paraná ; Curitiba-PR ; Raul V Heyde (PI) ; Fernanda P Resende ; Francisca E Zaina ; Hevila Araujo ; Maria LV Teixeira ; Michael JR Machado ; Rebecca Baumgartner ; Hospital de Clí ; nicas de Porto Alegre ; Porto Alegre-RS ; Gabriela Souza (PI) ; Bianca Fracasso ; Karen Ulliam ; Marina Schumacher ; Moara Pierotto ; Priccila Zuchinali ; Thamires Hilá ; rio ; Hospital de Messejana ; Fortaleza-CE ; Daniele MO Carlos (PI) ; Cintia GNC Cordeiro ; Daniele A Carvalho ; Marí ; lia S Gonç ; alves ; Valdiana Barbosa ; Hospital do Coraç ; ã ; o ; Sã ; o Paulo-SP ; Camila Torreglosa (PI) ; Jacqueline T Silva ; Rosa Bosquetti ; Marcelo LP Romano ; Cé ; sar A Jardim ; Bernardo NA de Abreu ; Hospital Nossa Senhora da Conceiç ; ã ; o ; Porto Alegre-RS ; Aline M Oliveira (PI) ; Alessandra R Schmitt ; Â ; ngela MV Tavares ; Christiane C Faria ; Flá ; via M Silva ; Jaqueline S Fink ; Hospital Sã ; o Lucas da Pontifí ; cia Universidade Cató ; lica do Rio Grande do Sul ; Porto Alegre-RS ; Raquel M El Kik (PI) ; Clarice F Prates ; Cristiane S Vieira ; Elaine F Adorne ; Ellen H Magedanz ; Fernanda L Chieza ; Ingrid S Silva ; Joise M Teixeira ; Hospital Sã ; o Lucas ; Aracaju-SE ; Antonio CS Sousa (PI) ; Andreza S Almeida ; Ariane A Costa ; José ; AC Carmo ; Juliana T Silva ; Luciana VS Alves ; Saulo OC Sales ; Hospital Universitá ; rio AESC ; Canoas-RS ; Maria EM Ramos (PI) ; Marilia CS Lucas ; Monica Damiani ; Patricia C Cardoso ; Salvador S Ramos ; Hospital Universitá ; rio Alcides Carneiro ; Campina Grande-PB ; Clenise F Dantas (PI) ; Amanda G Lopes ; Ana MP Cabral ; Ana CA Lucena ; Auriene L Medeiros ; Bernardino B Terceiro ; Neuma MFS Leda ; Sandra RD Baí ; a ; Hospital Universitá ; rio Ana Bezerra ; Santa Cruz-RN ; Josilene MF Pinheiro (PI) ; Alexandra N Cassiano ; Andressa NL Melo ; Anny KO Cavalcanti ; Camila WS Souza ; Dayanna JM Queiroz ; Hercilla NCF Farias ; Larissa CF Souza ; Letí ; cia S Santos ; Luana RM Lima ; Hospital Universitá ; rio de Brasí ; lia ; Brasí ; lia-DF ; Meg S Hoffmann (PI) ; Á ; tala S Silva Ribeiro ; Daniel F Vasconcelos ; Eliane S Dutra ; Marina K Ito ; Hospital Universitá ; rio da Universidade Federal do Maranhã ; o (HU-UFMA) ; José ; F Neto (PI) ; Alexsandro F Santos ; Rosâ ; ngela Maria L Sousa ; Luciana Pereira P Dias ; Maria TMA Lima ; Victor G Modanesi ; Adriana F Teixeira ; Hospital Universitá ; rio FUFSE ; Aracaju-SE ; Adriana BL Gomes (PI) ; Bá ; rbara Rocha ; Crisitna Teti ; Hospital Universitá ; rio Maria Aparecida Pedrossian ; Campo Grande- MS ; Marta M David (PI) ; Dé ; lcio GS Junior ; É ; rica HS Faria ; Michelle CF Oliveira ; Sandramara Sasso ; Hospital Universitá ; rio Pedro Ernesto ; Rio de Janeiro-RJ ; Annie SB Moreira (PI) ; Ana CAH Cadinha ; Carla WM Pisuto ; Mariana P Castilhos ; Instituto Dante Pazzanese de Cardiologia ; Sã ; o Paulo-SP ; Carlos D Magnoni (PI) ; Cristiane Kovacs ; Quê ; nia Silva ; Michele FCA Germini ; Renata Alves ; Instituto de Cardiologia do Rio Grande do Sul ; Porto Alegre-RS ; Soraia Polini (PI) ; Diana S Russo ; Izabele V Silveira ; Maria A Moraes ; Mirena Boklis ; Quinto I Cardoso ; Instituto Nacional de Cardiologia ; Rio de Janeiro-RJ ; Annie SB Moreira (PI) ; Aline MS Damaceno ; Elisa M Santos ; Glauber M Dias ; Pronto Socorro Cardioló ; gico Universitá ; rio de Pernambuco ; Recife-PE ; Clá ; udia PS Pinho (PI) ; Adrilene C Cavalcanti ; Amanda S Bezerra ; Andrey V Queiroga ; Isa G Rodrigues ; Tallita V Leal ; Hospital Universitá ; rio Professor Edgard Santos/ENUFBA/UFBA ; Salvador-BA ; Viviane Sahade (PI) ; Daniele A Amaral ; Diana S Souza ; Givaldo A Ara&uacute ; jo ; Karine Curvello ; Manuella Heine ; Marí ; lia MS Barretto ; Nailson A Reis ; Universidade Federal de Alagoas ; Maceió ; -AL ; Sandra M Vasconcelos (PI) ; Danielly C Vieira ; Francisco A Costa ; Jessica MS Fontes ; Juvenal GC Neto ; Laí ; s NP Navarro ; Raphaela C Ferreira ; Patrí ; cia M Marinho ; Universidade Federal de Pelotas ; Pelotas-RS ; Renata Torres Abib (PI) ; Aline Longo ; Eduardo G Bertoldi ; Lauren S Ferreira ; L&uacute ; cia R Borges ; Norlai A Azevedo ; Universidade Federal de Sã ; o Paulo ; Sã ; o Paulo-SP ; Celma M Martins (PI) ; Juliana T Kabo ; Maria CO Izar ; Mariana Capitani ; Valé ; ria A Machado ; Walé ; ria T Fronzar ; Universidade Federal de Tocantins ; Palmas-TO ; Sô ; nia L Pinto (PI) ; Kellen C Silva ; L&uacute ; cia HA Gratã ; o ; Sheila D Machado ; Susane RU Oliveira ; Universidade Federal de Viç ; osa ; Viç ; osa-MG ; Josefina Bressan (PI) ; Ana PS Caldas ; Hatanne CFM Lima ; Helen HM Hermsdorff ; Tâ ; nia M Saldanha ; Sí ; lvia E Priore ; Universidade Federal do Mato Grosso ; Cuiabá ; -MT ; Naoel H Feres (PI) ; Á ; dila Queiroz ; Loanda MG Cheim ; Nilma F Silva ; Silvia RL Reis ; URCAMP ; Bagé ; -RS ; Mô ; nica LP Santos (PI) ; Cí ; ntia L Ambró ; zio ; Cirí ; lia N Camejo ; Cristiano P Santos ; Gabriela S Schirmann ; Jorge L Boemo ; Paola R Scardoelli ; Rosane EC Oliveira ; S&uacute ; si MB Lima ; Vera MS Bortolini ; Universidade Vale do Itajaí ; Itajaí ; -SC ; Cristina H Matos (PI) ; Claiza Barretta ; Clarice M Specht ; InstitutoEstadualdeCardiologia AloysiodeCastro-IECAC ; SimoneRaimondi de Souza (PI) ; Cristina Arruda ; Priscila Alves Rodrigues
• 刊名：American Heart Journal
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：171
• 期：1
• 页码：73-81.e2
• 全文大小：482 K

文摘

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.