Educational Dietary Intervention in Early Cardiac Rehabilitation After Myocardial Infarction

June 3, 2026 updated by: Joanna Popiołek-Kalisz, Medical University of Lublin
The trial is designed to assess whether individualized nutritional education provides additional benefit beyond standard early cardiac rehabilitation in patients after myocardial infarction. Patients referred for cardiac rehabilitation after myocardial infarction are randomized to a control group receiving standard rehabilitation care or to an intervention group receiving standard care plus structured personalized dietary education. The educational intervention is tailored to baseline dietary habits, nutritional knowledge, and adherence to cardioprotective dietary recommendations. Outcomes include changes in diet quality, adherence to the Mediterranean diet, nutritional knowledge, anthropometric measures, and bioelectrical impedance analysis-derived body composition parameters. The study will evaluate the feasibility and effectiveness of integrating individualized dietary education into early cardiac rehabilitation after myocardial infarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lublin, Poland, 20-093
        • Medical University of Lublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age ≥18 years,
  • recent myocardial infarction treated according to standard clinical practice,
  • qualification for early cardiac rehabilitation after myocardial infarction,
  • clinically stable status at enrollment,
  • ability to participate in standard rehabilitation and additional nutritional education,
  • ability to complete dietary and nutritional knowledge questionnaires,
  • ability to undergo anthropometric measurements and bioelectrical impedance analysis,
  • provision of written informed consent.

Exclusion Criteria:

  • refusal or inability to provide informed consent,
  • contraindications to cardiac rehabilitation,
  • severe clinical instability, including unstable hemodynamic status, recurrent ischemia, uncontrolled arrhythmia, or decompensated heart failure, preventing participation in rehabilitation;
  • severe cognitive, psychiatric, or communication limitations preventing participation in educational sessions or reliable questionnaire completion,
  • conditions preventing valid body composition assessment (according to device producer e.g. large metal implants).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
Experimental: Additional education
Behavioral: Dietary education
Participants in the intervention group receive standard early cardiac rehabilitation supplemented with individualized dietary counselling provided by a trained dietitian. The counselling is tailored to baseline dietary habits, nutritional knowledge, cardiovascular risk factors, nutritional status, comorbidities, and body composition. The intervention focuses on improving adherence to cardioprotective and Mediterranean-style dietary recommendations, including higher intake of vegetables, fruit, whole-grain products, legumes, nuts, fish, and unsaturated fats, and reduced intake of saturated fats, highly processed foods, sweets, sugar-sweetened beverages, and excess salt. The intervention includes assessment of current diet, identification of key dietary errors, practical recommendations, and individualized nutrition-related goals during cardiac rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet quality
Time Frame: 3 months
Overall diet quality assessed with Diet Quality Index score derived from Dietary Habits and Nutrition Beliefs Questionnaire
3 months
Dietary knowledge
Time Frame: 3 months
Diet knowledge score derived from Dietary Habits and Nutrition Beliefs Questionnaire
3 months
Body mass
Time Frame: 3 months
3 months
Fat mass
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 31, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KE-0254/86/05/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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