Brazilian Cardioprotective Nutritional Program Trial

NCT ID: NCT01620398

Last Updated: 2018-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2534 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-05
• Study Completion Date: 2017-12-31

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.

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BALANCE

Intervention Type: BEHAVIORAL

Control Diet group

generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given.

Group Type: ACTIVE_COMPARATOR

Control diet

Intervention Type: BEHAVIORAL

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.

Interventions

BALANCE

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

DICA Br; PABC;

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernardete Berwanger, NC, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coração

Otávio Berwanger, MD, PhD

Role: STUDY_DIRECTOR

Hospital do Coração

Rafael M Soares, NC, MSc

Role: STUDY_CHAIR

Hospital do Coração

Rosana P Costa, NC, MSc

Role: STUDY_CHAIR

Hospital do Coração

Maria B Ross-Fernandes, NC, MSc

Role: STUDY_CHAIR

Hospital do Coração

Enilda S Lara, NC, PhD

Role: STUDY_CHAIR

Hopsital do Coração

Camila R Torreglosa, NC, MSc

Role: STUDY_CHAIR

Hospital do Coração

Ângela C Bersch-Ferreira, NC, MSc

Role: STUDY_CHAIR

Hospital do Coração

Jacqueline T da Silva, NC

Role: STUDY_CHAIR

Hospital do Coração

Andrea P Galante, NC, PhD

Role: STUDY_CHAIR

Hospital do Coração

Locations

Universidade Federal de Alagoas

Maceió, Alagoas, Brazil

Hospital Universitário Francisca Mendes

Manaus, Amazonas, Brazil

Hospital de Messejana

Fortaleza, Ceará, Brazil

Universidade de Fortaleza

Fortaleza, Ceará, Brazil

Hospital Universitário Professor Edgard Santos / ENUFBA / UFBA

Salvador, Estado de Bahia, Brazil

Hospital das Clínicas de Goiânia

Goiânia, Goiás, Brazil

Hospital Universitário Federal Presidente Dutra

São Luiz, Maranhão, Brazil

Universidade Federal do Mato Grosso

Cuiabá, Mato Grosso, Brazil

Hospital Universitário Maria Aparecida Pedrossian

Campo Grande, Mato Grosso do Sul, Brazil

Universidade Federal de Viçosa

Viçosa, Minas Gerais, Brazil

Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, Brazil

Hospital Universitário Alcides Carneiro

Campina Grande, Paraíba, Brazil

Hospital das Clínicas Gaspar Viana

Belém, Pará, Brazil

Pronto Socorro Cardiológico Universitário de Pernambuco

Recife, Pernambuco, Brazil

IECAC

Rio de Janeiro, Rio de Janeiro, 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

BIOSERV

Passo Fundo, Rio Grande do Sul, Brazil

Universidade Federal de Pelotas

Pelotas, Rio Grande do Sul, Brazil

COTENUT

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

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

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

Countries

Brazil

References

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Other Identifiers

BCDT

Identifier Type: -

Identifier Source: org_study_id