This trial is active, not recruiting.

Conditions coronary angioplasty, coronary disease
Treatments traditional, behavioral
Phase phase 3
Sponsor University of Sao Paulo General Hospital
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date April 2008
End date August 2009
Trial size 200 participants
Trial identifier NCT01028066, CAPPesq 0443/07, FAPESP 2007/54652-8


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
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.

Primary Outcomes

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)

Secondary 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

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - preserved cognitive status Exclusion Criteria: - no availability to attend the meetings of nutritional guidance

Additional Information

Official title Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial
Principal investigator Moacyr Roberto Cucê Nobre
Description Patients were hospitalized to realize elective coronary angioplasty in a especialized hospital in cardiovascular disease. All data were obtained by a trained nutritionist.
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.