Feeding Education in Patients Submitted to Coronary Angioplasty

NCT01028066 | Unknown Phase 3

• 2 other identifiers: CAPPesq 0443/07FAPESP 2007/54652-8
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Angioplasty; Coronary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes)

  1 year (all outcomes) and 3 years (all outcomes)

Secondary Outcomes (1)

• - 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

Study Arms (2)

Traditional

ACTIVE COMPARATOR

Traditional nutritional counseling

Other: Traditional

Behavioral

EXPERIMENTAL

Dialogic nutritional counseling

Behavioral: Behavioral

Interventions

Traditional OTHER

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.

Traditional

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.

Behavioral

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• preserved cognitive status

You may not qualify if:

• no availability to attend the meetings of nutritional guidance

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Coronary Disease; Feeding Behavior

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior, Animal; Behavior

Study Officials

• Moacyr Roberto Cucê Nobre

  Heart Institute HCFMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: January 1, 2012
• Last Updated: December 11, 2009

Record last verified: 2009-12

Locations

BR (1)