SLCTR Registration Number
Date of Registration
The date of last modification
Jan 02, 2017
Scientific Title of Trial
Effects of ‘plate model’ as a part of dietary intervention on rehabilitation of post myocardial infarction patients. A randomized, single blinded, interventional study.
Public Title of Trial
Effects of ‘plate model’ as a part of dietary intervention on rehabilitation of post myocardial infarction patients.
Disease of Health Condition(s) Studied
Post myocardial infarction rehabilitation
‘Plate model’ diet and risk factor modification in post MI patients,
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
EC-16-075 (ERC: Colombo)
What is the research question being addressed?
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?
Type of study
Randomized controlled trial
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.
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.
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.
Venous blood sample will be attempted to collect within 24 hours following the admission by which time the lipids are expected not to change due to acute MI (ACC/AHA Class I recommendation)
Primary outcome(s) - Time of assessment(s)
At baseline (visit 0), at completion of 4 weeks (follow-up 1), at completion of 12 weeks (follow-up 2)
For the intervention group only:
Secondary outcome(s) - Time of assessment(s)
Outcomes 1-6: At baseline (visit 0), at completion of 4 weeks (follow-up 1) and at completion of 12 weeks (follow-up 2).
Outcomes 7- 8: At baseline (visit 0), and at completion of 12 weeks (follow-up 2).
Outcome 9: At 4 weeks (until data saturation is achieved).
Target number/sample size
120 (60 in each arm)
Countries of recruitment
Anticipated start date
Anticipated end date
State of ethics review approval
Approved by the Ethics Review Committee, Faculty of Medicine, University of Colombo on 21st July 2016 (Ref: EC-16-075), and by the Ethics Review Committee of the National Hospital of Sri Lanka on 15th March 2016 (Ref: AAI/ETH/COM/2016)
Contact person for Scientific Queries/Principal Investigator
Dr.Ranil Jayawardena MBBS, MSc, PhD.
Department of Physiology, Faculty of Medicine, University of Colombo, 25 Kynsey Road, Colombo 8, Sri Lanka
Tel: 0094 11 2695300 [Ext: 203/204/205]
Fax: 0094 11 2691581
Contact Person for Public Queries
Dr.Pasindu Fernando MBBS
Institute of Cardiology, National Hospital of Sri Lanka, Kynsey Road, Colombo 8, Sri Lanka
Tel: (941) 691407, (941) 693040, (941) 693039
Fax: (941) 691407