Trial Outcomes & Findings for Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial (NCT NCT01453166)
NCT ID: NCT01453166
Last Updated: 2012-07-19
Results Overview
Change From Baseline in systolic blood pressure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
12 weeks
Results posted on
2012-07-19
Participant Flow
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
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
Participant milestones
| Measure |
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
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
39
|
|
Overall Study
COMPLETED
|
40
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial
Baseline characteristics by cohort
| Measure |
Brazilian Heart-prevent Meal
n=42 Participants
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
|
Heart Prevent Meal I
n=41 Participants
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
|
Heart Prevent Meal II
n=39 Participants
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.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Age Continuous
|
62 years
STANDARD_DEVIATION 7 • n=5 Participants
|
65 years
STANDARD_DEVIATION 8 • n=7 Participants
|
62 years
STANDARD_DEVIATION 11 • n=5 Participants
|
63 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
42 participants
n=5 Participants
|
41 participants
n=7 Participants
|
39 participants
n=5 Participants
|
122 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants who were evaluable at this time point were analyzed
Change From Baseline in systolic blood pressure
Outcome measures
| Measure |
Brazilian Heart-prevent Meal
n=40 Participants
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
|
Heart Prevent Meal I
n=41 Participants
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
|
Heart Prevent Meal II
n=39 Participants
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.
|
|---|---|---|---|
|
Systolic Blood Pressure
Baseline
|
127 mmHg
Standard Error 12 • Interval -18.5 to 5.2
|
129 mmHg
Standard Error 16 • Interval -6.5 to 3.0
|
128 mmHg
Standard Error 13 • Interval -11.9 to 1.8
|
|
Systolic Blood Pressure
12 weeks
|
117 mmHg
Standard Error 19 • Interval -17.5 to -3.4
|
126 mmHg
Standard Error 21 • Interval -10.1 to 1.8
|
123 mmHg
Standard Error 20 • Interval -8.9 to -0.2
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants who were evaluable at this time point were analyzed.
Change From Baseline in total Cholesterol
Outcome measures
| Measure |
Brazilian Heart-prevent Meal
n=40 Participants
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
|
Heart Prevent Meal I
n=41 Participants
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
|
Heart Prevent Meal II
n=39 Participants
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.
|
|---|---|---|---|
|
Total Cholesterol
Baseline
|
179 mg/dl
Standard Error 40
|
169 mg/dl
Standard Error 39
|
167 mg/dl
Standard Error 35
|
|
Total Cholesterol
12 weeks
|
163 mg/dl
Standard Error 39
|
154 mg/dl
Standard Error 41
|
148 mg/dl
Standard Error 30
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who were evaluable at this time point were analyzed
Change From Baseline in weight
Outcome measures
| Measure |
Brazilian Heart-prevent Meal
n=40 Participants
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
|
Heart Prevent Meal I
n=39 Participants
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
|
Heart Prevent Meal II
n=38 Participants
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.
|
|---|---|---|---|
|
Weight
Baseline
|
82.2 kg
Standard Error 14.9 • Interval -3.0 to -1.5
|
87.9 kg
Standard Error 15.9 • Interval -2.8 to -1.0
|
84.3 kg
Standard Error 15.9 • Interval -1.5 to -0.3
|
|
Weight
12 weeks
|
79.3 kg
Standard Error 14.9 • Interval -4.1 to -1.7
|
85.8 kg
Standard Error 14.5 • Interval -2.7 to -0.5
|
84.0 kg
Standard Error 16.1 • Interval -4.0 to -1.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who were evaluable at this time point were analyzed
Change From Baseline in wais circumference
Outcome measures
| Measure |
Brazilian Heart-prevent Meal
n=40 Participants
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
|
Heart Prevent Meal I
n=41 Participants
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
|
Heart Prevent Meal II
n=39 Participants
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.
|
|---|---|---|---|
|
Waist Circumference
Baseline
|
102 cm
Standard Error 12
|
108 cm
Standard Error 12
|
106 cm
Standard Error 11
|
|
Waist Circumference
12 weeks
|
99 cm
Standard Error 12
|
105 cm
Standard Error 9
|
102 cm
Standard Error 12
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who were evaluable at this time point were analyzed
Change From Baseline in blood glucose
Outcome measures
| Measure |
Brazilian Heart-prevent Meal
n=40 Participants
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
|
Heart Prevent Meal I
n=41 Participants
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
|
Heart Prevent Meal II
n=39 Participants
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.
|
|---|---|---|---|
|
Blood Glucose
Baseline
|
112 mg/dl
Standard Error 43
|
104 mg/dl
Standard Error 22
|
108 mg/dl
Standard Error 30
|
|
Blood Glucose
12 weeks
|
107 mg/dl
Standard Error 30
|
102 mg/dl
Standard Error 20
|
112 mg/dl
Standard Error 26
|
Adverse Events
Brazilian Heart-prevent Meal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heart Prevent Meal I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heart Prevent Meal II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Otavio Berwanger
Instituto de Ensino e Pesquisa do Hospital do Coração
Phone: + 55 11 30536677
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place