Feeding Education in Patients Submitted to Coronary Angioplasty (PTCA-Nutri)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Sao Paulo General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01028066
First received: December 8, 2009
Last updated: December 10, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Coronary Angioplasty
Coronary Disease
Other: Traditional
Behavioral: Behavioral
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: January 2012
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional
Traditional nutritional counseling
Other: 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.
Experimental: Behavioral
Dialogic nutritional counseling
Behavioral: 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preserved cognitive status

Exclusion Criteria:

  • no availability to attend the meetings of nutritional guidance
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01028066

Locations
Brazil
Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University
São Paulo, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Moacyr Roberto Cucê Nobre Heart Institute HCFMUSP
  More Information

No publications provided

Responsible Party: Moacyr Roberto Cucê Nobre, Heart Institute (InCor) HCFMUSP
ClinicalTrials.gov Identifier: NCT01028066     History of Changes
Other Study ID Numbers: CAPPesq 0443/07, FAPESP 2007/54652-8
Study First Received: December 8, 2009
Last Updated: December 10, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
nutritional intervention
nutritional counseling
feeding behavior
food consumption
angioplasty

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 29, 2014