Cardiovascular Diseases
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective diet plan to reduce cardiovascular risk factors of new cardiovascular events.
Detailed description
Cardiovascular diseases are the leading cause of mortality in both sexes in Brazil and worldwide. Modifying risk factors such as diet and lifestyle can prevent most cases of cardiovascular disease. This pilot trial is based on specific and traditional brazilian food. The objective is to reduce risk factors such as obesity, high blood pressure,dyslipidemia and diabetes in patients with cardiovascular disease history.
Interventions
OTHERBrazilian heart-prevent meal
Nutrient profile of the diets used was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, all foods included in the menu were low-cost and widely available at local markets
OTHERHeart prevent control meal weekly
received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
OTHERHeart prevent control Meal monthly
received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
Sponsors
Ministry of Health, Brazil
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any coronary artery disease evidence in the past 10 years; or any ischemic stroke or TIA evidence in the past 10 years; or peripheral arterial disease in the past 10 years; or at least one of the following additional risk factors: * Diabetes Mellitus; Hypertension; Dyslipidemia; Coronary artery disease family history; * Asymptomatic carotid artery disease; * Body mass index\> 25 kg/m2 for adults and\> 28 kg/m2 for seniors
Exclusion criteria
* Neurocognitive or psychiatric condition; * Life expectancy less than 6 months (eg, metastatic malignancy or other defined as clinical trial investigators). * Pregnancy or breast feeding. * Hepatic impairment defined as elevated liver enzymes above three times the upper limit of normal * Renal impairment defined as creatinine values higher than 1.5 mg/dL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 12 weeks | Change From Baseline in systolic blood pressure |
| Total Cholesterol | 12 weeks | Change From Baseline in total Cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 12 weeks | Change From Baseline in weight |
| Waist Circumference | 12 weeks | Change From Baseline in wais circumference |
| Blood Glucose | 12 weeks | Change From Baseline in blood glucose |
Countries
Brazil
Participant flow
Recruitment details
151 patients agreed to participate of the screening day in the Hospital do Coração in São Paulo Brazil. After eligibility set, From September 2011 to December 2011,122 patients were randomized for one of three treatment groups
Pre-assignment details
Of those ineligible, 9 missed the screening day, 14 did not present previews cardiovascular event, 3 declined to participate. After randomization, two patients were identified as ineligible to present chronic renal and hepatic insufficiency, and three dropped out of the study Among those who met inclusion criteria, 117 participants completed study
Participants by arm
| Arm | Count |
|---|---|
| Brazilian Heart-prevent Meal Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets | 42 |
| Heart Prevent Meal I Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions | 41 |
| Heart Prevent Meal II Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions. | 39 |
| Total | 122 |
Baseline characteristics
| Characteristic | Heart Prevent Meal I | Heart Prevent Meal II | Brazilian Heart-prevent Meal | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 16 Participants | 18 Participants | 59 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 23 Participants | 24 Participants | 63 Participants |
| Age Continuous | 65 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 11 | 62 years STANDARD_DEVIATION 7 | 63 years STANDARD_DEVIATION 9 |
| Region of Enrollment Brazil | 41 participants | 39 participants | 42 participants | 122 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 11 Participants | 41 Participants |
| Sex: Female, Male Male | 26 Participants | 24 Participants | 31 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 39 | 0 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 39 | 0 / 38 |
Outcome results
Primary
Systolic Blood Pressure
Change From Baseline in systolic blood pressure
Time frame: 12 weeks
Population: Participants who were evaluable at this time point were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brazilian Heart-prevent Meal | Systolic Blood Pressure | Baseline | 127 mmHg | Standard Error 12 |
| Brazilian Heart-prevent Meal | Systolic Blood Pressure | 12 weeks | 117 mmHg | Standard Error 19 |
| Heart Prevent Meal I | Systolic Blood Pressure | Baseline | 129 mmHg | Standard Error 16 |
| Heart Prevent Meal I | Systolic Blood Pressure | 12 weeks | 126 mmHg | Standard Error 21 |
| Heart Prevent Meal II | Systolic Blood Pressure | Baseline | 128 mmHg | Standard Error 13 |
| Heart Prevent Meal II | Systolic Blood Pressure | 12 weeks | 123 mmHg | Standard Error 20 |
Comparison: The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat.p-value: <0.0595% CI: [100, 140]ANOVA
Primary
Total Cholesterol
Change From Baseline in total Cholesterol
Time frame: 12 weeks
Population: Participants who were evaluable at this time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brazilian Heart-prevent Meal | Total Cholesterol | Baseline | 179 mg/dl | Standard Error 40 |
| Brazilian Heart-prevent Meal | Total Cholesterol | 12 weeks | 163 mg/dl | Standard Error 39 |
| Heart Prevent Meal I | Total Cholesterol | Baseline | 169 mg/dl | Standard Error 39 |
| Heart Prevent Meal I | Total Cholesterol | 12 weeks | 154 mg/dl | Standard Error 41 |
| Heart Prevent Meal II | Total Cholesterol | Baseline | 167 mg/dl | Standard Error 35 |
| Heart Prevent Meal II | Total Cholesterol | 12 weeks | 148 mg/dl | Standard Error 30 |
Comparison: The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat.p-value: 0.0595% CI: [140, 220]ANOVA
Secondary
Blood Glucose
Change From Baseline in blood glucose
Time frame: 12 weeks
Population: Participants who were evaluable at this time point were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brazilian Heart-prevent Meal | Blood Glucose | Baseline | 112 mg/dl | Standard Error 43 |
| Brazilian Heart-prevent Meal | Blood Glucose | 12 weeks | 107 mg/dl | Standard Error 30 |
| Heart Prevent Meal I | Blood Glucose | Baseline | 104 mg/dl | Standard Error 22 |
| Heart Prevent Meal I | Blood Glucose | 12 weeks | 102 mg/dl | Standard Error 20 |
| Heart Prevent Meal II | Blood Glucose | Baseline | 108 mg/dl | Standard Error 30 |
| Heart Prevent Meal II | Blood Glucose | 12 weeks | 112 mg/dl | Standard Error 26 |
Comparison: The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat.p-value: 0.0595% CI: [77, 137]ANOVA
Secondary
Waist Circumference
Change From Baseline in wais circumference
Time frame: 12 weeks
Population: Participants who were evaluable at this time point were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brazilian Heart-prevent Meal | Waist Circumference | 12 weeks | 99 cm | Standard Error 12 |
| Brazilian Heart-prevent Meal | Waist Circumference | Baseline | 102 cm | Standard Error 12 |
| Heart Prevent Meal I | Waist Circumference | Baseline | 108 cm | Standard Error 12 |
| Heart Prevent Meal I | Waist Circumference | 12 weeks | 105 cm | Standard Error 9 |
| Heart Prevent Meal II | Waist Circumference | Baseline | 106 cm | Standard Error 11 |
| Heart Prevent Meal II | Waist Circumference | 12 weeks | 102 cm | Standard Error 12 |
Comparison: The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat.p-value: 0.0595% CI: [88, 112]ANOVA
Secondary
Weight
Change From Baseline in weight
Time frame: 12 weeks
Population: Participants who were evaluable at this time point were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brazilian Heart-prevent Meal | Weight | Baseline | 82.2 kg | Standard Error 14.9 |
| Brazilian Heart-prevent Meal | Weight | 12 weeks | 79.3 kg | Standard Error 14.9 |
| Heart Prevent Meal I | Weight | Baseline | 87.9 kg | Standard Error 15.9 |
| Heart Prevent Meal I | Weight | 12 weeks | 85.8 kg | Standard Error 14.5 |
| Heart Prevent Meal II | Weight | Baseline | 84.3 kg | Standard Error 15.9 |
| Heart Prevent Meal II | Weight | 12 weeks | 84.0 kg | Standard Error 16.1 |
p-value: 0.0595% CI: [66, 95]ANOVA