Brazilian Cardioprotective Nutritional Program Trial (BALANCE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Instituto de Ensino e Pesquisa, Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01620398
First received: June 13, 2012
Last updated: September 2, 2015
Last verified: September 2015
  Purpose
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, this trial will investigate the effects of the Program on reducing cardiovascular events - such as cardiac arrest, acute myocardial infarction (AMI), stroke, myocardial revascularization, amputation for peripheral arterial disease, and hospitalization for unstable angina - or death in patients with established CVD. Moreover, it will evaluate the effects of the dietary program on reducing CV factors, such as BMI, waist circumference,

Condition Intervention
Cardiovascular Diseases
Behavioral: BALANCE
Behavioral: Cardioprotective diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Brazilian Cardioprotective Nutritional Program to Reduce Events and Risk Factors in Secondary Prevention for Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • MACE [ Time Frame: 48th month ] [ Designated as safety issue: No ]
    Major cardiovascular events


Secondary Outcome Measures:
  • Total cholesterol [ Time Frame: 48 month ] [ Designated as safety issue: Yes ]
  • LDL [ Time Frame: 48 month ] [ Designated as safety issue: Yes ]
    Cholesterol, LDL

  • Blood Glucose [ Time Frame: 48 month ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: 48 month ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 48 month ] [ Designated as safety issue: Yes ]
    Body mass index

  • WC [ Time Frame: 48 month ] [ Designated as safety issue: Yes ]
    waist circumference


Estimated Enrollment: 2100
Study Start Date: February 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Cardioprotective diet group
generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given.
Behavioral: Cardioprotective 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.
Other Name: a generalized diet counseling prepared by dietitians based on low fat, low energy, low sodium and low cholesterol diets

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 we aim 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 it is our objective 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. We will randomize 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 cardiovascular death, cardiac arrest, acute myocardial infarction, stroke, and 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. We enrolled 2536 patients in 34 sites. Enrollment was open in March 2013 and ended in March 2015 and patients will be followed up to 48 months.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    • History of angina (clinical diagnosis, even without exams)
    • History of stroke
    • History of abnormal segmental wall motion in cardiac echocardiography (even without symptoms) or a fixed segmental defect in radionuclide imaging test (even if no symptoms)
    • History of a positive stress test with radionuclide stress test on echocardiography or pharmacologic cardiovascular stress testing demonstrating ischemic heart disease
    • History of coronary angiography or coronary angiography atherosclerotic stenosis ≥ 50% diameter in any coronary artery
    • ECG with pathological Q-waves in two contiguous leads.
  • Any evidence of stroke or TIA in the past 10 years, as defined by any of the following criteria:

    • Medical diagnosis of stroke or TIA
    • Evidence of previous stroke
  • Peripheral Arterial Disease (PAD) in the last 10 years, defined by a diagnosis of current or previous history of any of the following criteria:

    • Intermittent claudication
    • amputation
    • Vascular surgery for atherosclerotic disease
    • Value ankle/arm <0.90 for systolic blood pressure in either leg at rest
    • Angiography or Doppler showing> 70% stenosis in an artery noncardiac
  • Current or previous hospitalization for unstable angina

Exclusion Criteria:

  • Refusal to provide Informed Consent Statement
  • neurocognitive or psychiatric condition that prevents obtaining reliable clinical data (defined by clinical trial investigators)
  • Life expectancy less than 6 months
  • Pregnancy or lactation
  • Severe hepatic encephalopathy
  • Renal Failure with indication for dialysis
  • Congestive heart failure
  • Patients with organ transplants prior
  • Wheelchair
  • Difficulty in receiving oral diet
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620398

Locations
Brazil
Universidade Federal de Alagoas
Maceió, Alagoas, 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
Voçosa, 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
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição
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
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90630000
Associação Veranense de Assistência em Saúde (AVAES)
Veranópolis, Rio Grande do Sul, Brazil, 90630000
Hospital Universitário Pedro Ernesto
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
Principal Investigator: 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 de 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
  More Information

No publications provided

Responsible Party: Instituto de Ensino e Pesquisa, Research Institute HCor, Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01620398     History of Changes
Other Study ID Numbers: BCDT 
Study First Received: June 13, 2012
Last Updated: September 2, 2015
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 04, 2016