Brazilian Cardioprotective Nutritional Program Trial (BALANCE)

May 24, 2018 updated by: Hospital do Coracao

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2534

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Brasília, Brazil
        • Hospital Universitário de Brasília
      • Rio de Janeiro, Brazil
        • Hospital Universitário Pedro Ernesto
      • Rio de Janeiro, Brazil
        • Instituto Nacional de Cardiologia
      • São Paulo, Brazil
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, Brazil
        • Universidade Federal de Sao Paulo
      • São Paulo, Brazil
        • Hospital do Coracao
    • Alagoas
      • Maceió, Alagoas, Brazil
        • Universidade Federal de Alagoas
    • Amazonas
      • Manaus, Amazonas, Brazil
        • Hospital Universitário Francisca Mendes
    • Bahia
      • Salvador, Bahia, Brazil
        • Hospital Universitário Professor Edgard Santos / ENUFBA / UFBA
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Hospital de Messejana
      • Fortaleza, Ceará, Brazil
        • Universidade de Fortaleza
    • Goiás
      • Goiânia, Goiás, Brazil, 90630000
        • Hospital das Clínicas de Goiânia
    • Maranhão
      • São Luiz, Maranhão, Brazil
        • Hospital Universitário Federal Presidente Dutra
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brazil
        • Universidade Federal do Mato Grosso
    • Mato Grosso Do Sul
      • Campo Grande, Mato Grosso Do Sul, Brazil
        • Hospital Universitario Maria Aparecida Pedrossian
    • Minas Gerais
      • Viçosa, Minas Gerais, Brazil
        • Universidade Federal de Viçosa
    • Paraiba
      • Campina Grande, Paraiba, Brazil
        • Hospital Universitário Alcides Carneiro
    • Paraná
      • Curitiba, Paraná, Brazil
        • Hospital de Clínicas da Universidade Federal do Paraná
    • Pará
      • Belém, Pará, Brazil
        • Hospital das Clínicas Gaspar Viana
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Pronto Socorro Cardiológico Universitário de Pernambuco
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • IECAC
    • Rio Grande Do Norte
      • Santa Cruz, Rio Grande Do Norte, Brazil
        • Hospital Universitário Ana Bezerra
    • Rio Grande Do Sul
      • Bagé, Rio Grande Do Sul, Brazil
        • URCAMP
      • Canoas, Rio Grande Do Sul, Brazil, 90630000
        • Hospital Universitário AESC
      • Passo Fundo, Rio Grande Do Sul, Brazil, 90630000
        • BIOSERV
      • Pelotas, Rio Grande Do Sul, Brazil
        • Universidade Federal de Pelotas
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Instituto de Cardiologia do Rio Grande do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90630000
        • COTENUT
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90630000
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90630000
        • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
      • Veranópolis, Rio Grande Do Sul, Brazil, 90630000
        • Associação Veranense de Assistência em Saúde (AVAES)
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil
        • Universidade Vale do Itajaí
    • Sergipe
      • Aracaju, Sergipe, Brazil
        • Hospital sao lucas
      • Aracaju, Sergipe, Brazil
        • Hospital Universitário FUFSE
    • Tocantins
      • Palmas, Tocantins, Brazil
        • Universidade Federal de Tocantins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 48 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 48 month
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
up to 48 month
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.
up to 48 month
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
up to 48 month
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.
up to 48 month
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.
up to 48 month
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
up to 48 month
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.
up to 48 month
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.
up to 48 month
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.
up to 48 month
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.
up to 48 month
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.
up to 48 month
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.
up to 36 month
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.
up to 36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Coracao

Investigators

  • Principal Investigator: Bernardete Berwanger, NC, PhD, Hospital do Coracao
  • Study Director: Otávio Berwanger, MD, PhD, Hospital do Coracao
  • Study Chair: Rafael M Soares, NC, MSc, Hospital do Coracao
  • Study Chair: Rosana P Costa, NC, MSc, Hospital do Coracao
  • Study Chair: Maria B Ross-Fernandes, NC, MSc, Hospital do Coracao
  • Study Chair: Enilda S Lara, NC, PhD, Hopsital do Coração
  • Study Chair: Camila R Torreglosa, NC, MSc, Hospital do Coracao
  • Study Chair: Ângela C Bersch-Ferreira, NC, MSc, Hospital do Coracao
  • Study Chair: Jacqueline T da Silva, NC, Hospital do Coracao
  • Study Chair: Andrea P Galante, NC, PhD, Hospital do Coracao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 5, 2013

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (ESTIMATE)

June 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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