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.

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

Cardiovascular Diseases

BALANCE

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.

Control diet

Universidade Federal de Alagoas

Hospital Universitário Francisca Mendes

Hospital Universitário Professor Edgard Santos / ENUFBA / UFBA

Hospital de Messejana

Universidade de Fortaleza

Hospital das Clínicas de Goiânia

Hospital Universitário Federal Presidente Dutra

Hospital Universitário Maria Aparecida Pedrossian

Universidade Federal do Mato Grosso

Universidade Federal de Viçosa

Hospital Universitário Alcides Carneiro

Hospital de Clínicas da Universidade Federal do Paraná

Hospital das Clínicas Gaspar Viana

Pronto Socorro Cardiológico Universitário de Pernambuco

Hospital Universitário Ana Bezerra

URCAMP

Hospital Universitário AESC

BIOSERV

Universidade Federal de Pelotas

COTENUT

Hospital de Clínicas de Porto Alegre

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

Instituto de Cardiologia do Rio Grande do Sul

Associação Veranense de Assistência em Saúde (AVAES)

IECAC

Universidade Vale do Itajaí

Hospital São Lucas

Hospital Universitário FUFSE

Universidade Federal de Tocantins

Hospital Universitário de Brasília

Hospital Universitario Pedro Ernesto

Instituto Nacional de Cardiologia

Hospital do Coração

Instituto Dante Pazzanese de Cardiologia

Universidade Federal de São Paulo

Brazilian Cardioprotective Nutritional Program Trial

The Brazilian Cardioprotective Nutritional Program to Reduce Events and Risk Factors in Secondary Prevention for Cardiovascular Disease

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.

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.

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

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

saturated fatty acid/infarkt

Brazilian Cardioprotective Nutritional Program Trial

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