Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial
16. juli 2012 opdateret af: Hospital do Coracao
The Effect of Brazilian Heart Prevent Meal Program Accessible for the Population to Prevent New Cardiovascular Events: A Pilot Randomized Clinical Trial
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
122
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Sao Paulo, Brasilien, 04005000
- Hospital do Coracao
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group 1
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
|
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
Andre navne:
|
|
Eksperimentel: Group 2
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
|
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
Andre navne:
|
|
Eksperimentel: Group 3
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.
|
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Systolic Blood Pressure
Tidsramme: 12 weeks
|
Change From Baseline in systolic blood pressure
|
12 weeks
|
|
Total Cholesterol
Tidsramme: 12 weeks
|
Change From Baseline in total Cholesterol
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight
Tidsramme: 12 weeks
|
Change From Baseline in weight
|
12 weeks
|
|
Waist Circumference
Tidsramme: 12 weeks
|
Change From Baseline in wais circumference
|
12 weeks
|
|
Blood Glucose
Tidsramme: 12 weeks
|
Change From Baseline in blood glucose
|
12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Bernardete Weber, PhD, Hospital do Coracao
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2011
Primær færdiggørelse (Faktiske)
1. december 2011
Studieafslutning (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først indsendt
11. oktober 2011
Først indsendt, der opfyldte QC-kriterier
13. oktober 2011
Først opslået (Skøn)
17. oktober 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. juli 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2012
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 01/2011
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hjerte-kar-sygdomme
-
Ottawa Hospital Research InstituteAfsluttetStress | Crisis Resource Management (CRM) færdigheder | Advanced Cardiovascular Life Support (ACLS) færdighederCanada