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Feeding Education in Patients Submitted to Coronary Angioplasty

Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01028066
Acronym
PTCA-Nutri
Enrollment
200
Registered
2009-12-09
Start date
2008-04-30
Completion date
2012-01-31
Last updated
2009-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Angioplasty, Coronary Disease

Keywords

nutritional intervention, nutritional counseling, feeding behavior, food consumption, angioplasty

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.

Interventions

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.

BEHAVIORALBehavioral

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.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* preserved cognitive status

Exclusion criteria

* no availability to attend the meetings of nutritional guidance

Design outcomes

Primary

MeasureTime frame
Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes)1 year (all outcomes) and 3 years (all outcomes)

Secondary

MeasureTime frame
- 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 risk1 year

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026