Feeding Education in Patients Submitted to Coronary Angioplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients were hospitalized to realize elective coronary angioplasty in a especialized hospital in cardiovascular disease. All data were obtained by a trained nutritionist.

Official Title
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Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial

Conditions
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Coronary Angioplasty, Coronary Disease

Intervention / Treatment
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* Other: Traditional
* Behavioral: Behavioral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preserved cognitive status Exclusion Criteria: no availability to attend the meetings of nutritional guidance
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional<br>Traditional nutritional counseling | Other: Traditional<br>* 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.<br>|
| Experimental: Behavioral<br>Dialogic nutritional counseling | Behavioral: Behavioral<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes) |  | 1 year (all outcomes) and 3 years (all outcomes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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 |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutritional intervention, nutritional counseling, feeding behavior, food consumption, angioplasty