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Brazilian Cardioprotective Nutritional Program Trial (BALANCE)

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ClinicalTrials.gov Identifier: NCT01620398
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

Brief Summary:
There are no studies exploring the benefits of a diet composed of typical Brazilian food in the secondary prevention of cardiovascular diseases. Randomized studies show that the Mediterranean diet is beneficial for patients with established cardiovascular disease or in risk for CVD development. Indeed, nutritional composition of the Mediterranean Diet is one of main references for dietary guidelines for treatment and prevention of CVD in Brazil and the world. However, in many countries, such as Brazil, most foods of the Mediterranean diet are not widely available, may be expensive or are not part of population eating habits. So, the prescription of the Mediterranean diet intervention for cardiovascular disease to the Brazilian population may not be feasible, leading to a low adherence. In this context, patients with established CVD have a low compliance to nutritional prescription. The BALANCE Program, considers 3 concepts: a) A dietary prescription guided by nutritional content recommendations from the Brazilian national guidelines; b) A nutritional education program based on fun, playful strategies and suggestions of affordable foods; and c) Intensive follow-up through one-on-one visits, group sessions, and phone calls. This is the first proposal to use these concepts concurrently with the objective to increase adherence of secondary prevention patients to the diet proposed by the guidelines. Therefore, 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: BALANCE Behavioral: Control diet Not Applicable

Detailed Description:

The BALANCE Program will investigate the effect of the Program in reducing cardiovascular events, such as cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, hospitalization for unstable angina, or death in patients with established cardiovascular disease. Moreover the aim is to evaluate the effect of the dietary program on reducing cardiovascular risk factors, such as body mass index, waist circumference, blood pressure, total cholesterol, low density lipoprotein (LDL), triglycerides and fasting glucose. Also the objective is to compare the dietary patterns after interventions, the effect of the intervention among nutrients and energy consumption and, finally, to evaluate the BALANCE Program comprehension.

The BALANCE Program is a randomized, multicenter, national trial with allocation concealment and intention-to-treat analysis. The elegibility criteria is patients aged 45 years or more with any evidence of established cardiovascular disease to the BALANCE program or control groups. BALANCE Program is composed by 3 concepts: a) a diet that provides 50-60% of energy from carbohydrate, 10-15% from protein, 25-35% from total fat, <7% from saturated fatty acids, <10% polyunsaturated fatty acids, <20% monounsaturated fatty acids, <1% trans fats, <200 mg/day cholesterol, 20-30 g/day fiber, and <2,400 mg/day sodium; b) Nutrition education program based on ludic strategies and indication of affordable foods; c) An intense follow up by individual and group visits and phone calls. For Control group, generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given. The primary composite outcome is the occurrence of of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease or hospitalization for unstable angina. Blinded assessors will adjudicate clinical events and analysis will follow the intention-to-treat principle. Were enrolled 2534 patients in 35 sites. Enrollment was open in March 2013 and ended in March 2015 and patients will be followed up to 48 months.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Brazilian Cardioprotective Nutritional Program to Reduce Events and Risk Factors in Secondary Prevention for Cardiovascular Disease
Actual Study Start Date : March 5, 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: BALANCE group
BALANCE Program is composed by 3 concepts: a) a diet composed of 50-60% of energy from carbohydrate, 10-15% of energy from protein; 25-35% of energy from fat (<7% saturated fatty acid; <10% polyunsaturated fatty acid; <20% monounsaturated fatty acid, <1% trans fatty acid), <200 mg/day of cholesterol, 20-30 g/day of fiber and <2400 mg/day of sodium; b) Nutrition education program based on ludic strategies and indication of affordable foods; c) An intense follow up by individual and group visits and phone calls.
Behavioral: BALANCE
Other Names:
  • DICA Br;
  • PABC;

Active Comparator: Control Diet group
generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given.
Behavioral: Control diet
Participants will be encourage to follow a generalized diet counseling prepared by dietitians based on low fat, low energy, low sodium and low cholesterol diets. They will receive a common folder composed by lists of foods that should be preferred or avoided. For example, avoidance of ultra processed foods, preference for boiled and baked foods rather than fried foods and recommendation of having at least five meals a day. This folder is equivalent of several that are given on ambulatories or hospital of Brazilian public health.




Primary Outcome Measures :
  1. Composity of Major Cardiovascular Events [ Time Frame: up to 48 month ]

    The primary composite outcome will be the occurrence of any of the following cardiovascular events: cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, hospitalization for unstable angina, cardiovascular death, or death from any cause.

    The Clinical Endpoints Committee (CEC) will be responsible for adjudication of primary composite outcome components. All suspected events will be entered into the CEC tracking database and independently reviewed by two CEC physicians. If the two adjudicators agree, event adjudication will be considered complete. If there is disagreement, the final decision will be made by a third, independent adjudicator.

    It will be reported in events per person-years and crude rate per 1000 person-years.



Secondary Outcome Measures :
  1. Total cholesterol (mg/dl) [ Time Frame: up to 48 month ]
    For biochemical analyses blood samples will be collected and handled according to routine hospital practice. All participants will be fasted for at least 12 hours before phlebotomy. It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations.

  2. LDL - cholesterol (mg/dl) [ Time Frame: up to 48 month ]
    For biochemical analyses blood samples will be collected and handled according to routine hospital practice. It will be estinated by Friedewald formula. All participants will be fasted for at least 12 hours before phlebotomy. It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations

  3. Fasting glucose (mg/dL) [ Time Frame: up to 48 month ]
    For biochemical analyses blood samples will be collected and handled according to routine hospital practice. All participants will be fasted for at least 12 hours before phlebotomy. It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations.

  4. Blood pressure (mmHg) [ Time Frame: up to 48 month ]
    It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations

  5. Body-mass index (kg/m2) [ Time Frame: up to 48 month ]
    Compose by body weight (in kilograms) and body height (in meters), reported in kg/m².It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations.

  6. waist circumference (cm) [ Time Frame: up to 48 month ]
    It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations. The values of the circumferences will be expressed in centimeters (cm). The waist circumference should be measured through the midpoint between the lower border of the costal arch and the iliac crest in the medial axillary line.

  7. Triglycerides (mg/dL) [ Time Frame: up to 48 month ]

    For biochemical analyses blood samples will be collected and handled according to routine hospital practice. All participants will be fasted for at least 12 hours before phlebotomy.

    It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations


  8. isolated occurrence of cardiovascular events [ Time Frame: up to 48 month ]

    cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, hospitalization for unstable angina, or isolated cardiovascular death.

    The Clinical Endpoints Committee (CEC) will be responsible for adjudication of primary composite outcome components. All suspected events will be entered into the CEC tracking database and independently reviewed by two CEC physicians. If the two adjudicators agree, event adjudication will be considered complete. If there is disagreement, the final decision will be made by a third, independent adjudicator.

    It will be reported in events per person-years and crude rate per 1000 person-years.


  9. isolated cardiovascular death or death from any cause [ Time Frame: up to 48 month ]

    isolated cardiovascular death or death from any cause The Clinical Endpoints Committee (CEC) will be responsible for adjudication of primary composite outcome components. All suspected events will be entered into the CEC tracking database and independently reviewed by two CEC physicians. If the two adjudicators agree, event adjudication will be considered complete. If there is disagreement, the final decision will be made by a third, independent adjudicator.

    It will be reported in events per person-years and crude rate per 1000 person-years.


  10. nutrient and energy intake analysis [ Time Frame: up to 48 month ]

    It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations.

    Dietary intake data was assessed from two 24-hour recall from each visit, collected by trained interviewers. Nutrients will be present in grams/day and in % of calories and energy in Kcal.


  11. dietary pattern analysis [ Time Frame: up to 48 month ]
    a posteriori and/or a priori analysis. The dietary intake data will be obtain from two 24-hour recalls and the nutrient variability was adjusted by the Multiple Source Method (MSM). Dietary patterns were obtained by principal component analysis, and the scores were categorized into tertiles.

  12. BALANCE Program comprehension [ Time Frame: up to 48 month ]

    Each telephone monitoring will address questions about the nutritional guidelines received by the patient in order to identify the understanding of the information after the follow-up visit. The answers will be imputed in an electronic system developed for the telephone monitoring of DICA Br.

    It will be analysed by chi-square and/or regression analysis.


  13. Cost-effectiveness analysis of clinical events (U$/events) [ Time Frame: up to 36 month ]

    A cost-effectiveness analysis will be performed taking into consideration the societal perspective. BALANCE diet cost and the healthcare expenditures will be estimated in both intervention and control groups among individuals who were adherent to BALANCE study protocol.

    Clinical outcomes will determine the effectiveness of the BALANCE study. The expected clinical outcomes are death, cardiac arrest, myocardial infarction, stroke, myocardial revascularization, amputation, or angina. Differences between the cost-effectiveness rates fwill determine the cost-effectiveness analysis of clinical events. External validity will be performed using sensibility analyses.


  14. Cost-effectiveness analysis of diet quality (U$/DQIscore) [ Time Frame: up to 36 month ]

    A cost-effectiveness analysis will be performed taking into consideration the societal perspective. BALANCE diet cost and the healthcare expenditures will be estimated in both intervention and control groups among individuals who were adherent to BALANCE study protocol.

    Diet quality will be obtained by diet quality index (DQI) and will determine the effectiveness of the BALANCE study.

    Differences between the cost-effectiveness rates will determine the Cost-effectiveness analysis of diet quality External validity will be performed using sensibility analyses.




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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any evidence of coronary artery disease (CAD) over the preceding 10 years, as defined by any of the following criteria:

    • defined by previous myocardial infarction,
    • stable or unstable angina,
    • history of atherosclerotic stenosis ≥70% of the diameter of any coronary artery on conventional or computed tomographic (CT) coronary angiography,
    • history of angioplasty, stenting, or coronary artery bypass surgery)
  • Any evidence of stroke in the preceding 10 years
  • Peripheral Arterial Disease over the preceding 10 years, as defined by any of the following criteria:

    • ankle/arm ratio <0.9 of systolic blood pressure in either leg at rest, angiography or Doppler demonstrating >70% stenosis in a cardiac artery,
    • intermittent claudication,
    • vascular surgery for atherosclerotic disease,
    • amputation due to atherosclerotic disease,
    • aortic aneurysm

Exclusion Criteria:

  • Refusal to provide Informed Consent Statement
  • neurocognitive or psychiatric condition that may hinder collection of reliable clinical data (defined at the trial investigator's discretion)
  • Life expectancy less than 6 months
  • Pregnancy or lactation
  • Liver failure with a history of encephalopathy or anasarca
  • Renal Failure with indication for dialysis
  • Congestive heart failure
  • Previous organ transplantation
  • Wheelchair use
  • Any restrictions to receiving an oral diet.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620398


Locations
Brazil
Universidade Federal de Alagoas
Maceió, Alagoas, Brazil
Hospital Universitário Francisca Mendes
Manaus, Amazonas, Brazil
Hospital Universitário Professor Edgard Santos / ENUFBA / UFBA
Salvador, Bahia, Brazil
Hospital de Messejana
Fortaleza, Ceará, Brazil
Universidade de Fortaleza
Fortaleza, Ceará, Brazil
Hospital das Clínicas de Goiânia
Goiânia, Goiás, Brazil, 90630000
Hospital Universitário Federal Presidente Dutra
São Luiz, Maranhão, Brazil
Hospital Universitário Maria Aparecida Pedrossian
Campo Grande, Mato Grosso Do Sul, Brazil
Universidade Federal do Mato Grosso
Cuiabá, Mato Grosso, Brazil
Universidade Federal de Viçosa
Viçosa, Minas Gerais, Brazil
Hospital Universitário Alcides Carneiro
Campina Grande, Paraiba, Brazil
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, Brazil
Hospital das Clínicas Gaspar Viana
Belém, Pará, Brazil
Pronto Socorro Cardiológico Universitário de Pernambuco
Recife, Pernambuco, Brazil
Hospital Universitário Ana Bezerra
Santa Cruz, Rio Grande Do Norte, Brazil
URCAMP
Bagé, Rio Grande Do Sul, Brazil
Hospital Universitário AESC
Canoas, Rio Grande Do Sul, Brazil, 90630000
BIOSERV
Passo Fundo, Rio Grande Do Sul, Brazil, 90630000
Universidade Federal de Pelotas
Pelotas, Rio Grande Do Sul, Brazil
COTENUT
Porto Alegre, Rio Grande Do Sul, Brazil, 90630000
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90630000
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande Do Sul, Brazil, 90630000
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande Do Sul, Brazil
Associação Veranense de Assistência em Saúde (AVAES)
Veranópolis, Rio Grande Do Sul, Brazil, 90630000
IECAC
Rio de Janeiro, RJ, Brazil
Universidade Vale do Itajaí
Itajaí, Santa Catarina, Brazil
Hospital São Lucas
Aracaju, Sergipe, Brazil
Hospital Universitário FUFSE
Aracaju, Sergipe, Brazil
Universidade Federal de Tocantins
Palmas, Tocantins, Brazil
Hospital Universitário de Brasília
Brasília, Brazil
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Brazil
Instituto Nacional de Cardiologia
Rio de Janeiro, Brazil
Hospital do Coração
São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Universidade Federal de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Hospital do Coracao
Investigators
Principal Investigator: Bernardete Berwanger, NC, PhD Hospital do Coração
Study Director: Otávio Berwanger, MD, PhD Hospital do Coração
Study Chair: Rafael M Soares, NC, MSc Hospital do Coração
Study Chair: Rosana P Costa, NC, MSc Hospital do Coração
Study Chair: Maria B Ross-Fernandes, NC, MSc Hospital do Coração
Study Chair: Enilda S Lara, NC, PhD Hopsital do Coração
Study Chair: Camila R Torreglosa, NC, MSc Hospital do Coração
Study Chair: Ângela C Bersch-Ferreira, NC, MSc Hospital do Coração
Study Chair: Jacqueline T da Silva, NC Hospital do Coração
Study Chair: Andrea P Galante, NC, PhD Hospital do Coração

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Weber B, Bersch-Ferreira ÂC, Torreglosa CR, Ross-Fernandes MB, da Silva JT, Galante AP, Lara Ede S, Costa RP, Soares RM, Cavalcanti AB, Moriguchi EH, Bruscato NM, Kesties, Vivian L, Schumacher M, de Carli W, Backes LM, Reolão BR, Rodrigues MP, Baldissera DM, Tres GS, Lisbôa HR, Bem JB, Reolão JB, Deucher KL, Cantarelli M, Lucion A, Rampazzo D, Bertoni V, Torres RS, Verríssimo AO, Guterres AS, Cardos AF, Coutinho DB, Negrão MG, Alencar MF, Pinho PM, Barbosa SN, Carvalho AP, Taboada MI, Pereira SA, Heyde RV, Nagano FE, Baumgartner R, Resende FP, Tabalipa R, Zanini AC, Machado MJ, Araujo H, Teixeira ML, Souza GC, Zuchinali P, Fracasso BM, Ulliam K, Schumacher M, Pierotto M, Hilário T, Carlos DM, Cordeiro CG, Carvalho DA, Gonçalves MS, Vasconcelos VB, Bosquetti R, Pagano R, Romano ML, Jardim CA, de Abreu BN, Marcadenti A, Schmitt AR, Tavares AM, Faria CC, Silva FM, Fink JS, El Kik RM, Prates CF, Vieira CS, Adorne EF, Magedanz EH, Chieza FL, Silva IS, Teixeira JM, Trescastro EP, Pellegrini LA, Pinto JC, Telles CT, Sousa AC, Almeida AS, Costa AA, Carmo JA, Silva JT, Alves LV, Sales SO, Ramos ME, Lucas MC, Damiani M, Cardoso PC, Ramos SS, Dantas CF, Lopes AG, Cabral AM, Lucena AC, Medeiros AL, Terceiro BB, Leda NM, Baía SR, Pinheiro JM, Cassiano AN, Melo AN, Cavalcanti AK, Souza CV, Queiroz DJ, Farias HN, Souza LC, Santos LS, Lima LR, Hoffmann MS, Ribeiro ÁS, Vasconcelos DF, Dutra ES, Ito MK, Neto JA, Santos AF, Sousa RM, Dias LP, Lima MT, Modanesi VG, Teixeira AF, Estrada LC, Modanesi PV, Gomes AB, Rocha BR, Teti C, David MM, Palácio BM, Junior DG, Faria ÉH, Oliveira MC, Uehara RM, Sasso S, Moreira AS, Cadinha AC, Pinto CW, Castilhos MP, Costa M, Kovacs C, Magnoni D, Silva Q, Germini MF, da Silva RA, Monteiro AS, dos Santos KG, Moreira P, Amparo FC, Paiva CC, Poloni S, Russo DS, Silveira IV, Moraes MA, Boklis M, Cardoso QI, Moreira AS, Damaceno AM, Santos EM, Dias GM, Pinho CP, Cavalcanti AC, Bezerra AS, Queiroga AV, Rodrigues IG, Leal TV, Sahade V, Amaral DA, Souza DS, Araújo GA, Curvello K, Heine M, Barretto MM, Reis NA, Vasconcelos SM, Vieira DC, Costa FA, Fontes JM, Neto JG, Navarro LN, Ferreira RC, Marinho PM, Abib RT, Longo A, Bertoldi EG, Ferreira LS, Borges LR, Azevedo NA, Martins CM, Kato JT, Izar MC, Asoo MT, de Capitani MD, Machado VA, Fonzar WT, Pinto SL, Silva KC, Gratão LH, Machado SD, de Oliveira SR, Bressan J, Caldas AP, Lima HC, Hermsdorff HH, Saldanha TM, Priore SE, Feres NH, Neves Ade Q, Cheim LM, Silva NF, Reis SR, Penafort AM, de Queirós AP, Farias GM, de los Santos ML, Ambrozio CL, Camejo CN, dos Santos CP, Schirmann GS, Boemo JL, Oliveira RE, Lima SM, Bortolini VM, Matos CH, Barretta C, Specht CM, de Souza SR, Arruda CS, Rodrigues PA, Berwanger O. The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial). Am Heart J. 2016 Jan;171(1):73-81.e1-2. doi: 10.1016/j.ahj.2015.08.010. Epub 2015 Aug 15.

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01620398     History of Changes
Other Study ID Numbers: BCDT
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospital do Coracao:
cardiovascular diseases
secondary prevention
diet

Additional relevant MeSH terms:
Cardiovascular Diseases