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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
History of Changes

December 8, 2009
December 10, 2009
April 2008
August 2009   (final data collection date for primary outcome measure)
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 ]
Recurrent cardiovascular event (restenosis of the vessel, angina, myocardial infarction and sudden death proved) and all causes of mortality [ Time Frame: 1 year (all outcomes) and 3 years (only mortality) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01028066 on ClinicalTrials.gov Archive Site
- 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 ]
Same as current
Not Provided
Not Provided
 
Feeding Education in Patients Submitted to Coronary Angioplasty
Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial

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.

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

All data were obtained by a trained nutritionist.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Coronary Angioplasty
  • Coronary Disease
  • 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.
  • 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.
  • Active Comparator: Traditional
    Traditional nutritional counseling
    Intervention: Other: Traditional
  • Experimental: Behavioral
    Dialogic nutritional counseling
    Intervention: Behavioral: Behavioral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2012
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • preserved cognitive status

Exclusion Criteria:

  • no availability to attend the meetings of nutritional guidance
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01028066
CAPPesq 0443/07, FAPESP 2007/54652-8
No
Moacyr Roberto Cucê Nobre, Heart Institute (InCor) HCFMUSP
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Moacyr Roberto Cucê Nobre Heart Institute HCFMUSP
University of Sao Paulo General Hospital
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP