Brazilian Cardioprotective Nutritional Program Trial
- Conditions
- Cardiovascular Diseases
- Interventions
- Behavioral: Control dietBehavioral: BALANCE
- Registration Number
- NCT01620398
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2534
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Diet group Control diet generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given. BALANCE group BALANCE 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.
- Primary Outcome Measures
Name Time Method Composity of Major Cardiovascular Events 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
Name Time Method LDL - cholesterol (mg/dl) 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
Blood pressure (mmHg) up to 48 month It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations
waist circumference (cm) 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.
Triglycerides (mg/dL) 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 equationsBALANCE Program comprehension 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.Total cholesterol (mg/dl) 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.
Fasting glucose (mg/dL) 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.
Body-mass index (kg/m2) 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.
nutrient and energy intake analysis 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.dietary pattern analysis 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.
Cost-effectiveness analysis of diet quality (U$/DQIscore) 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.isolated occurrence of cardiovascular events 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.isolated cardiovascular death or death from any cause 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.Cost-effectiveness analysis of clinical events (U$/events) 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.
Trial Locations
- Locations (35)
Hospital Universitário Ana Bezerra
🇧🇷Santa Cruz, Rio Grande Do Norte, Brazil
Universidade Federal de Viçosa
🇧🇷Viçosa, Minas Gerais, Brazil
BIOSERV
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Universitário AESC
🇧🇷Canoas, Rio Grande Do Sul, Brazil
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
URCAMP
🇧🇷Bagé, Rio Grande Do Sul, Brazil
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Universidade Federal de Tocantins
🇧🇷Palmas, Tocantins, Brazil
Hospital das Clínicas de Goiânia
🇧🇷Goiânia, Goiás, Brazil
Universidade de Fortaleza
🇧🇷Fortaleza, Ceará, Brazil
Hospital de Clínicas da Universidade Federal do Paraná
🇧🇷Curitiba, Paraná, Brazil
Hospital Universitário Francisca Mendes
🇧🇷Manaus, Amazonas, Brazil
Universidade Federal do Mato Grosso
🇧🇷Cuiabá, Mato Grosso, Brazil
Hospital Universitário Federal Presidente Dutra
🇧🇷São Luiz, Maranhão, Brazil
Hospital Universitário Professor Edgard Santos / ENUFBA / UFBA
🇧🇷Salvador, Bahia, Brazil
Universidade Federal de Alagoas
🇧🇷Maceió, Alagoas, Brazil
Hospital de Messejana
🇧🇷Fortaleza, Ceará, Brazil
Instituto Dante Pazzanese de Cardiologia
🇧🇷São Paulo, Brazil
Universidade Federal de São Paulo
🇧🇷São Paulo, Brazil
Instituto Nacional de Cardiologia
🇧🇷Rio de Janeiro, Brazil
IECAC
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital São Lucas
🇧🇷Aracaju, Sergipe, Brazil
Hospital do Coração
🇧🇷São Paulo, Brazil
Hospital Universitário Maria Aparecida Pedrossian
🇧🇷Campo Grande, Mato Grosso Do Sul, Brazil
Hospital Universitário Alcides Carneiro
🇧🇷Campina Grande, Paraiba, Brazil
COTENUT
🇧🇷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 Universitário FUFSE
🇧🇷Aracaju, Sergipe, Brazil
Hospital Universitario Pedro Ernesto
🇧🇷Rio de Janeiro, Brazil
Hospital Universitário de Brasília
🇧🇷Brasília, Brazil
Hospital das Clínicas Gaspar Viana
🇧🇷Belém, Pará, Brazil
Pronto Socorro Cardiológico Universitário de Pernambuco
🇧🇷Recife, Pernambuco, Brazil