NCT07172906

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Oct 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

June 12, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

June 12, 2025

Last Update Submit

September 8, 2025

Conditions

Keywords

Coronary Artery Bypass GraftingNutritional Education from nursesWeight measurementadherence to the Mediterranean diet

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months from the first meeting

Secondary Outcomes (4)

  • Improvement in body weight (kg) of patients

    Until 6 months from the first meeting with the researcher

  • Improving patients' Body Mass Index to healthy limits

    6 months from the first meeting

  • improvement of patients' body fat percentage (%) and body water percentage (%)

    Until 6 months from the first meeting

  • Improving patients' chest, waist and hip circumferences (cm) to healthy limits

    Until 6 months from the first meeting

Study Arms (2)

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.

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" questionnaireBehavioral: Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaireBehavioral: 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.

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" questionnaireBehavioral: Patients of Group A and B both are filling out "Nottingham Health Profile Scale" questionnaireBehavioral: Patients of Group A and B both are filling out the "Cardiovascular Diet Questionnaire-2"Other: Measurement of patient somatometric characteristicsBehavioral: Nutritional education and discussion with group B patients

Interventions

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.

Group A (Control Group)Intervention Group (Group B)

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.

Group A (Control Group)Intervention Group (Group B)

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.

Group A (Control Group)Intervention Group (Group B)

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.

Group A (Control Group)Intervention Group (Group B)

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.

Group A (Control Group)Intervention Group (Group B)

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 Group (Group B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Nursing, Hellenic Mediterranean University

Study Record Dates

First Submitted

June 12, 2025

First Posted

September 15, 2025

Study Start

October 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.