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OpenTrials
Completed

NCT Number: NCT07624240

Educational Dietary Intervention in Early Cardiac Rehabilitation After Myocardial Infarction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Lublin

Lublin, 20-093, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dietary Education

Behavioral

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.

Primary outcomes

  1. Diet quality

    Time frame: 3 months

    Overall diet quality assessed with Diet Quality Index score derived from Dietary Habits and Nutrition Beliefs Questionnaire

  2. Dietary knowledge

    Time frame: 3 months

    Diet knowledge score derived from Dietary Habits and Nutrition Beliefs Questionnaire

  3. Body mass

    Time frame: 3 months

  4. Fat mass

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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