"Nutrition Education by Nurses in Patients After Coronary Artery Bypass Grafting: Effect on Patients' Dietary Pattern, Adherence and Clinical Outcomes"

NCT ID: NCT07172906

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-10-31

Brief Summary

The purpose of this study is the investigation of the effect of nurse-led nutritional education of post-CABG patients on their dietary pattern, on their adherence to it, but also on their quality of life and well-being.

Detailed Description

Introduction Cardiovascular disease is the leading cause of death worldwide, leading to approximately 18 million deaths annually. Coronary Artery Bypass Grafting (CABG) is the surgical treatment of coronary artery disease, which improves patients' symptoms and quality of life. However, successful postoperative recovery requires the adoption of a healthy lifestyle, including proper nutrition. Research shows that a diet high in unsaturated fat and low in saturated fat can improve the metabolic profile and cardiovascular function, reducing morbidity and potential complications. In addition, a balanced diet contributes to improving mental health and well-being, reducing anxiety and the occurrence of cognitive disorders such as postoperative delirium. Therefore, adherence to a healthy dietary pattern is crucial for the long-term management of the disease and the successful recovery of cardiac surgery patients.

Methodology A clinical study will be conducted with manipulation of independent variables and creation of a control group. Patients will be approached and randomly assigned to two groups: a) the control group (Group A), where patients will receive standard care based on the policy and protocols of the Tertiary Hospitals and b) the Intervention Group (Group B), where patients will receive nurse-led education through oral sessions, provision of an educational form and telephone calls at regular intervals.

The Greek versions of the Mediterranean Diet Screener (MEDAS), Mini Nutritional Assessment (MNA) and Nottingham Health Profile Scale questionnaires, while translation and weighting will be carried out in the Greek population for the Cardiovascular Diet Questionnaire 2 (CDQ-2). The above aims to assess patients' compliance with specific dietary habits, while the latter concerns primarily cardiac patients. Questionnaires will be completed by all patients at the initial meeting and after 1, 3 and 6 months. Training and objective measurements will be performed only on patients in the intervention group. The statistical analysis of the data will be done with the SPSS program (version 26) and using descriptive and inductive statistical analysis methods.

Expected Results The proposed thesis aims to highlight the importance of nurse-led nutrition education in the care of patients after CABG. Education, through a variety of formats such as oral sessions, printed materials, home visits and telephone calls, is expected to improve patient outcomes, reducing the chances of hospital readmissions and improving their quality of life. In addition, it is expected to strengthen their adherence to healthy eating habits, contributing to the secondary and tertiary prevention of cardiovascular disease, and to reduce morbidity and mortality.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group A (Control Group)

These are patients who will have their body measurements, weight, body fat and water percentage measured. They will also complete the questionnaires that will be included in the study, but they will not receive any nutritional education from the researcher.

Group Type: ACTIVE_COMPARATOR

Patients of Group A and B both are filling out the questionnaire "Mediterranean diet questionnaire (MEDAS)"

Intervention Type: BEHAVIORAL

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the patients' dietary choices and how beneficial they are for their health, according to the Mediterranean diet model.

Patients of Group A and B both are filling out the "Mini Nutritional Asessment" questionnaire

Intervention Type: BEHAVIORAL

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the nutritional status of the patients, their level of nutrition and appetite for food, and the potential risk of malnutrition.

Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire

Intervention Type: BEHAVIORAL

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the subjective discomfort of the individual with health problems as well as the extent to which these problems affect their normal activities.

Patients of Group A and B both are filling out the "Cardiovascular Diet Questionnaire-2"

Intervention Type: BEHAVIORAL

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the dietary choices of patients with cardiovascular diseases, such as the patients in this study.

Measurement of patient somatometric characteristics

Intervention Type: OTHER

Measurement of body weight, Body Mass Index, Fat and Water Percentage, Chest, Waist and Hip Circumference of patients using a tape measure and electronic scale-lipometer. Also, measurement of bloodless blood pressure and fasting glucose.

Intervention Group (Group B)

These are patients who will have their body measurements, weight, body fat and water percentage measured. They will also complete the questionnaires that will be included in the study. These patients will receive nutritional education from the researcher, through an information sheet, phone calls and messages. The goal is to improve their measurements and their nutritional choices due to this education, compared to the patients in Group A.

Group Type: ACTIVE_COMPARATOR

Patients of Group A and B both are filling out the questionnaire "Mediterranean diet questionnaire (MEDAS)"

Intervention Type: BEHAVIORAL

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the patients' dietary choices and how beneficial they are for their health, according to the Mediterranean diet model.

Patients of Group A and B both are filling out the "Mini Nutritional Asessment" questionnaire

Intervention Type: BEHAVIORAL

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the nutritional status of the patients, their level of nutrition and appetite for food, and the potential risk of malnutrition.

Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire

Intervention Type: BEHAVIORAL

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the subjective discomfort of the individual with health problems as well as the extent to which these problems affect their normal activities.

Patients of Group A and B both are filling out the "Cardiovascular Diet Questionnaire-2"

Intervention Type: BEHAVIORAL

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the dietary choices of patients with cardiovascular diseases, such as the patients in this study.

Measurement of patient somatometric characteristics

Intervention Type: OTHER

Measurement of body weight, Body Mass Index, Fat and Water Percentage, Chest, Waist and Hip Circumference of patients using a tape measure and electronic scale-lipometer. Also, measurement of bloodless blood pressure and fasting glucose.

Nutritional education and discussion with group B patients

Intervention Type: BEHAVIORAL

Nutritional education using an information leaflet, e-mails and telephone calls to patients in group B only. Discussion regarding their dietary choices before surgery, identification of wrong habits and efforts to improve them afterwards. It will concern all the basic categories of healthy eating (preference for fruits, vegetables, proteins, healthy carbohydrates, reduction of saturated fat, salt and sugar and information about nutritional labels and how to choose foods according to them). The goal is for patients who will receive this education to improve their measurements in repeat meetings with the researcher, compared to those who will not be informed.

Interventions

Patients of Group A and B both are filling out the questionnaire "Mediterranean diet questionnaire (MEDAS)"

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the patients' dietary choices and how beneficial they are for their health, according to the Mediterranean diet model.

Intervention Type: BEHAVIORAL

Patients of Group A and B both are filling out the "Mini Nutritional Asessment" questionnaire

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the nutritional status of the patients, their level of nutrition and appetite for food, and the potential risk of malnutrition.

Intervention Type: BEHAVIORAL

Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the subjective discomfort of the individual with health problems as well as the extent to which these problems affect their normal activities.

Intervention Type: BEHAVIORAL

Patients of Group A and B both are filling out the "Cardiovascular Diet Questionnaire-2"

This questionnaire will be completed by patients in both groups. The aim of this questionnaire is to assess the dietary choices of patients with cardiovascular diseases, such as the patients in this study.

Intervention Type: BEHAVIORAL

Measurement of patient somatometric characteristics

Measurement of body weight, Body Mass Index, Fat and Water Percentage, Chest, Waist and Hip Circumference of patients using a tape measure and electronic scale-lipometer. Also, measurement of bloodless blood pressure and fasting glucose.

Intervention Type: OTHER

Nutritional education and discussion with group B patients

Nutritional education using an information leaflet, e-mails and telephone calls to patients in group B only. Discussion regarding their dietary choices before surgery, identification of wrong habits and efforts to improve them afterwards. It will concern all the basic categories of healthy eating (preference for fruits, vegetables, proteins, healthy carbohydrates, reduction of saturated fat, salt and sugar and information about nutritional labels and how to choose foods according to them). The goal is for patients who will receive this education to improve their measurements in repeat meetings with the researcher, compared to those who will not be informed.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age over 18 years
• Patients who underwent CABG and were discharged from the hospital in the previous 10 days
• Knowledge of reading and writing in Greek by the patients
• Provision of written informed consent by the patients for their participation in the study

Exclusion Criteria

• History of psychiatric illness, recent history of alcohol and/or drug abuse, dementia or Alzheimer's disease
• Patients with comorbidities (diabetes mellitus, chronic renal failure, idiopathic inflammatory bowel disease, other gastrointestinal disorders, food allergies, etc.) that would justify the adoption of a special dietary pattern that is not identical to the proposed dietary pattern
• Patients with a preference for strict vegetarianism (vegan) and/or cultural-religious beliefs that do not allow the adoption of the proposed dietary pattern

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University General Hospital of Heraklion

OTHER

Sponsor Role: collaborator

Hellenic Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Giakoumidakis

Associate Professor, Department of Nursing, Hellenic Mediterranean University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

7736/20-02-2025

Identifier Type: -

Identifier Source: org_study_id