Feeding Education in Patients Submitted to Coronary Angioplasty

Phase 3

• Conditions: Coronary Angioplasty; Coronary Disease
• Interventions: Other: Traditional; Behavioral: Behavioral

• Registration Number: NCT01028066
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

Patients were hospitalized to realize elective coronary angioplasty in a especialized hospital in cardiovascular disease.

All data were obtained by a trained nutritionist.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-08
• Status Verified: 2009-12
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Last Update Submitted: 2009-12-10
• Last Update Posted: 2009-12-11
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• preserved cognitive status

Exclusion Criteria

• no availability to attend the meetings of nutritional guidance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional	Traditional	Traditional nutritional counseling
Behavioral	Behavioral	Dialogic nutritional counseling

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
- 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

Trial Locations

Locations (1)

Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University; 🇧🇷 São Paulo, Brazil