Back to resultsFeeding Education in Patients Submitted to Coronary Angioplasty (PTCA-Nutri)
Primary Purpose
Coronary Angioplasty, Coronary Disease
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Traditional
Behavioral
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Angioplasty focused on measuring nutritional intervention, nutritional counseling, feeding behavior, food consumption, angioplasty
Eligibility Criteria
Inclusion Criteria:
- preserved cognitive status
Exclusion Criteria:
- no availability to attend the meetings of nutritional guidance
Sites / Locations
- Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional
Behavioral
Arm Description
Traditional nutritional counseling
Dialogic nutritional counseling
Outcomes
Primary Outcome Measures
Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes)
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
Full Information
NCT ID
NCT01028066
First Posted
December 8, 2009
Last Updated
December 10, 2009
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01028066
Brief Title
Feeding Education in Patients Submitted to Coronary Angioplasty
Acronym
PTCA-Nutri
Official Title
Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Angioplasty, Coronary Disease
Keywords
nutritional intervention, nutritional counseling, feeding behavior, food consumption, angioplasty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional
Arm Type
Active Comparator
Arm Description
Traditional nutritional counseling
Arm Title
Behavioral
Arm Type
Experimental
Arm Description
Dialogic nutritional counseling
Intervention Type
Other
Intervention Name(s)
Traditional
Intervention Description
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
Behavioral
Intervention Name(s)
Behavioral
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
- 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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
preserved cognitive status
Exclusion Criteria:
no availability to attend the meetings of nutritional guidance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moacyr Roberto Cucê Nobre
Organizational Affiliation
Heart Institute HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Feeding Education in Patients Submitted to Coronary Angioplasty
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