Feeding Education in Patients Submitted to Coronary Angioplasty (PTCA-Nutri)
|ClinicalTrials.gov Identifier: NCT01028066|
Recruitment Status : Unknown
Verified December 2009 by University of Sao Paulo General Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 9, 2009
Last Update Posted : December 11, 2009
The simple knowledge that practices healthy lifestyle are important to reduce or prevent the progression of cardiovascular diseases it is not enough for effective changes accordingly. To nutritional education be successful, needs to promote changes in eating habits and not just transmit information. This is a behavioral intervention study in 200 consecutive patients submitted to percutaneous transluminary coronary angioplasty. The participants were randomized in two groups: intervention and control.
The intervention was a dialogic nutritional counseling and the control arm was a traditional nutritional counseling.
All participants will undergo long-term follow-up for cardiovascular events.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Angioplasty Coronary Disease||Other: Traditional Behavioral: Behavioral||Phase 3|
Patients were hospitalized to realize elective coronary angioplasty in a especialized hospital in cardiovascular disease.
All data were obtained by a trained nutritionist.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||January 2012|
Active Comparator: Traditional
Traditional nutritional counseling
The control group will have access to the nutritionist to clear any doubts about the diet prescribed when went out the hospital and will be invited to attend a meeting nutrition in dialogic character at the end of 1 year to ensure fairness in action.
Dialogic nutritional counseling
The intervention group will go through 4 meetings of food education, to be held within the institution, with approximately 1 hour long, composed of 3 to 8 patients, who may or may not be accompanied by a relative. The first three meetings will be monthly and the fourth will be 6 months after the last one. Each meeting will be developed within the context of dialogic and participatory education, directed to the adoption of a healthy diet and prevention and control of cardiovascular risk factors. The meetings will follow the order: Investigation, Contextualization, Awareness and Strengthening the nutritional concepts, according to the didactics of educator Paulo Freire.
- Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes) [ Time Frame: 1 year (all outcomes) and 3 years (all outcomes) ]
- - Evaluate changes in eating habits, according to the transtheoretical model to adopt healthy eating habits - Check change in food intake - Identify the nutritional status and cardiovascular risk [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028066
|Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University|
|São Paulo, Brazil, 05403000|
|Principal Investigator:||Moacyr Roberto Cucê Nobre||Heart Institute HCFMUSP|