Is the ‘plate model’ diet effective as a part of dietary intervention on modification of selected cardio-metabolic risk factors in Post Myocardial Infarction patients?

Study site: Institute of Cardiology, National Hospital of Sri Lanka.

Method of recruitment and allocation into the study arms: Subjects will be voluntary participants who are admitted to Unit I,II,IV and V of Cardiology Unit, NHSL, and diagnosed to have troponin positive ACS. Subjects will be allocated to control and test groups using simple randomization.

Intervention arm
Provision of model plate.

1) ‘My rice plate’ is a 3D plate made of melamine which is designed to control portion size of each food group with the visual reinforcement with different colour segments assigned for each food group. A food poster will be provided to improve compliance to plate model diet and a food diary will be used as a monitoring tool in follow up visits.

2) Each patient will be given one-to-one education, each session lasting about 5-10 min a day until the discharge, which comprises information regarding the exercise, general life style modification in post MI period such as cessation of smoking, cutting down alcohol etc. Dietary advice will be provided by a research assistant trained by a nutrition specialist, exercise advice by a physiotherapist and other aspects of education will be provided by nursing officers of respective setting which the patient is managed in. Therefore on average each patient will receive an education time of 30-45 min during the total period of hospital stay.

3) Two separate booklets will be provided to the patients free of charge to reinforce the health education delivered to the patients verbally.

4) Other medical management will be provided on an individual basis according to the standard guidelines and ward protocols.

Control arm

1) Routine dietary advice will be provided such as reduce intake of fat, sugar and salt.

2) Intervention 2, 3 and 4 will be the same as for the test group.

1. Age between 20 years to 70 years
   
2. The patients who developed acute coronary event(STEMI, NSTEMI) regardless of the history of unstable angina, STEMI defined as new ST elevation at the J point in at least 2 contiguous leads of ?2 mm (0.2 mV) in men or ?1.5 mm (0.15 mV) in women in leads V2–V3 and/or of ?1 mm (0.1 mV) in other contiguous chest leads or the limb leads , New or presumably new LBBB, NSTEMI is diagnosed in the absence of above ECG changes although in the presence of cardiac biomarker positivity (according to ACC/ AHA guidelines)
   
3. Troponin I >0.5 ng/ml and CK-MB > 5.0 ng/ml. The diagnosis is made by the admitting medical officer and before recruiting the patient the investigator will also confirm the presence of above criteria.
   
4. Diagnosis of acute coronary event within the past 1 month.
   
5. Patients who are eating homemade rice for main meals at least two times a day.
   
6. Patients who consume rice for at least two main meals a day.
   
7. Patients who are able to attend to clinic follow-ups in a monthly basis.
   
8. Patients whose BMI is more than 23 kgm-2

1. End stage renal failure (stage III or more), Congestive cardiac failure (NYHA class III and above), Chronic liver cell disease ( Child- Pugh score class B or more) Severe anaemia (Haemoglobin < 8.0 g/dl for both men and women).
   
2. Pregnancy or breast feeding.
   
3. Any documented infection with systemic effects; i.e. developed high grade fever, Abnormal leucocyte count> 11,000/microliter, or ESR > 22mm/1st hour for men and 29mm/1st hour for women, within last 2 weeks.
   
4. Patients who are already on a modified diet or dietary supplements.