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Not yet recruiting NCT07172906

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

No phase Interventional Coronary Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patients of Group A and B both are filling out the questionnaire "Mediterranean diet questionnaire (MEDAS)", Patients of Group A and B both are filling out the "Mini Nutritional Asessment" questionnaire, Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire, Patients of Group A and B both are filling out the "Cardiovascular Diet Questionnaire-2".
Who it may be relevant to
Registry conditions: Coronary Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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.
  • 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.
  • 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.
  • 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.
  • Other 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.
  • Behavioral 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 g

Primary outcome measures

  • Improving dietary choices and habits of patients with Coronary Heart Disease who underwent coronary artery bypass surgery [Time frame: 6 months from the first meeting]
Secondary outcome measures (4)
  • Improvement in body weight (kg) of patients [Time frame: Until 6 months from the first meeting with the researcher]
  • Improving patients' Body Mass Index to healthy limits [Time frame: 6 months from the first meeting]
  • improvement of patients' body fat percentage (%) and body water percentage (%) [Time frame: Until 6 months from the first meeting]
  • Improving patients' chest, waist and hip circumferences (cm) to healthy limits [Time frame: Until 6 months from the first meeting]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07172906 · 7736/20-02-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗