Coronary Heart DiseaseNCT07172906
"Nutrition Education by Nurses in Patients After Coronary Artery Bypass Grafting: Effect on Patients' Dietary Pattern, Adherence and Clinical Outcomes"
A study testing 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 and Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire in people with Coronary Heart Disease, run by Hellenic Mediterranean University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- 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 and Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- 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", Measurement of patient somatometric characteristics
- Keywords
- Coronary Artery Bypass Grafting, Nutritional Education from nurses, Weight measurement, adherence to the Mediterranean diet
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients of Group A and B both are filling out the questionnaire "Mediterranean diet questionnaire (MEDAS)"Behavioural
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" questionnaireBehavioural
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" questionnaireBehavioural
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"Behavioural
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 characteristicsOther
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 patientsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control Group) | Active comparator | 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. Receives: Behavioral: Patients of Group A and B both are filling out the questionnaire "Mediterranean diet questionnaire (MEDAS)"; Behavioral: Patients of Group A and B both are filling out the "Mini Nutritional Asessment" questionnaire; Behavioral: Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire; Behavioral: Patients of Group A and B both are filling out the "Cardiovascular Diet Questionnaire-2"; Other: Measurement of patient somatometric characteristics |
| Intervention Group (Group B) | Active comparator | 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. Receives: Behavioral: Patients of Group A and B both are filling out the questionnaire "Mediterranean diet questionnaire (MEDAS)"; Behavioral: Patients of Group A and B both are filling out the "Mini Nutritional Asessment" questionnaire; Behavioral: Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire; Behavioral: Patients of Group A and B both are filling out the "Cardiovascular Diet Questionnaire-2"; Other: Measurement of patient somatometric characteristics; Behavioral: Nutritional education and discussion with group B patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving dietary choices and habits of patients with Coronary Heart Disease who underwent coronary artery bypass surgery
Through nutritional education and discussion with the researcher, the goal is for patients to understand healthy eating choices, make better choices regarding their diet, and improve the outcome of surgery.
Measured: 6 months from the first meeting
Secondary outcomes (4)
Improvement in body weight (kg) of patients
Through the nutritional education that patients will receive, they will be able to properly understand healthy dietary choices and improve their body weight (mainly overweight and obese patients will be able to reduce it to healthy limits). Their weight will be measured with an electronic scale.
Measured: Until 6 months from the first meeting with the researcher
Improving patients' Body Mass Index to healthy limits
Through the nutritional education that patients will receive, they will be able to properly understand healthy dietary choices and improve their Body Mass Index. Body mass index will be calculated using an electronic scale after body weight has been measured.
Measured: 6 months from the first meeting
improvement of patients' body fat percentage (%) and body water percentage (%)
Due to improved dietary choices after training, patients will be able to improve their body fat and water percentage (especially overweight and obese patients). These parameters will be calculated with a special scale - lipometer, after measuring body weight and also calculating the patient's gender, age and height.
Measured: Until 6 months from the first meeting
Improving patients' chest, waist and hip circumferences (cm) to healthy limits
In addition to improving the parameters of weight, fat, water and Body Mass Index, it is important to improve the measurements of the patients' chest, waist and hip circumferences to healthy limits (reduction in overweight and obese patients and increase in malnourished patients). This measurement will be done with a tape measure by the researcher.
Measured: Until 6 months from the first meeting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Mediterranean University
- Sponsor type
- University, hospital or other
- Collaborators
- University General Hospital of Heraklion
- Responsible party
- Principal investigator, Konstantinos Giakoumidakis, Hellenic Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172906
- Sponsor's protocol ID
- 7736/20-02-2025
- Status last verified
- Sep 2025
- First submitted
- 12 Jun 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected will be anonymous, used exclusively for the purposes of the research, and will be accessible only to the principal investigator. Participants will provide written consent, having been fully informed that the process is anonymous, their personal information and responses will be used exclusively for research purposes, and they can withdraw at any time. All data will be stored and will remain stored for as long as necessary until their analysis and then destroyed.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Nutrition Education by Nurses in Patients After Coronary Artery Bypass Grafting: Effect on Patients' Dietary Pattern, Adherence and Clinical Outcomes"
- ClinicalTrials.gov ID
- NCT07172906
- Acronym / sponsor ID
- 7736/20-02-2025
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Artery Bypass Grafting, Nutritional Education from nurses, Weight measurement, adherence to the Mediterranean diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hellenic Mediterranean UniversityUniversity, hospital or other
- Collaborators
- University General Hospital of Heraklion
- Study start
- Oct 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group) | Active comparator | Behavioral: Patients of Group A and B both are filling out the questionnaire "Mediterranean diet questionnaire (MEDAS)", Behavioral: Patients of Group A and B both are filling out the "Mini Nutritional Asessment" questionnaire, Behavioral: Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire, Behavioral: Patients of Group A and B both are filling out the "Cardiovascular Diet Questionnaire-2", Other: Measurement of patient somatometric characteristicsThese 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. |
| Intervention Group (Group B) | Active comparator | Behavioral: Patients of Group A and B both are filling out the questionnaire "Mediterranean diet questionnaire (MEDAS)", Behavioral: Patients of Group A and B both are filling out the "Mini Nutritional Asessment" questionnaire, Behavioral: Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire, Behavioral: Patients of Group A and B both are filling out the "Cardiovascular Diet Questionnaire-2", Other: Measurement of patient somatometric characteristics, Behavioral: Nutritional education and discussion with group B patientsThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group A (Control Group), Intervention Group (Group B) |
| Patients of Group A and B both are filling out the "Mini Nutritional Asessment" questionnaireThis 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. | Behavioural | Group A (Control Group), Intervention Group (Group B) |
| Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaireThis 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. | Behavioural | Group A (Control Group), Intervention Group (Group B) |
| 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. | Behavioural | Group A (Control Group), Intervention Group (Group B) |
| Measurement of patient somatometric characteristicsMeasurement 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. | Other | Group A (Control Group), Intervention Group (Group B) |
| Nutritional education and discussion with group B patientsNutritional 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. | Behavioural | Intervention Group (Group B) |
Primary outcome
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
Through nutritional education and discussion with the researcher, the goal is for patients to understand healthy eating choices, make better choices regarding their diet, and improve the outcome of surgery.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No. The data collected will be anonymous, used exclusively for the purposes of the research, and will be accessible only to the principal investigator. Participants will provide written consent, having been fully informed that the process is anonymous, their personal information and responses will be used exclusively for research purposes, and they can withdraw at any time. All data will be stored and will remain stored for as long as necessary until their analysis and then destroyed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaire in people with Coronary Heart Disease, run by Hellenic Mediterranean University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.