Feeding Education in Patients Submitted to Coronary Angioplasty

NCT ID: NCT01028066

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-01-31

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.

Conditions

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Coronary Angioplasty Coronary Disease

Keywords

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nutritional intervention nutritional counseling feeding behavior food consumption angioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Traditional

Traditional nutritional counseling

Group Type ACTIVE_COMPARATOR

Traditional

Intervention Type OTHER

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.

Behavioral

Dialogic nutritional counseling

Group Type EXPERIMENTAL

Behavioral

Intervention Type BEHAVIORAL

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.

Interventions

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Traditional

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.

Intervention Type OTHER

Behavioral

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* preserved cognitive status

Exclusion Criteria

* no availability to attend the meetings of nutritional guidance
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Heart Institute (InCor) HCFMUSP

Principal Investigators

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Moacyr Roberto Cucê Nobre

Role: PRINCIPAL_INVESTIGATOR

Heart Institute HCFMUSP

Locations

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Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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FAPESP 2007/54652-8

Identifier Type: -

Identifier Source: secondary_id

CAPPesq 0443/07

Identifier Type: -

Identifier Source: org_study_id