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Effects of ‘plate model’ as a part of dietary intervention on rehabilitation of post myocardial infarction patients. A randomized, single blinded, interventional study. -

SLCTR Registration Number

SLCTR/2016/022


Date of Registration

22 Sep 2016

The date of last modification

Jan 02, 2017



Application Summary


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


Scientific Acronym

None


Public Acronym

None


Brief title

‘Plate model’ diet and risk factor modification in post MI patients,


Universal Trail Number

U1111-1182-0891


Any other number(s) assigned to the trial and issuing authority

EC-16-075 (ERC: Colombo)


Trial Details


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded


Control

Active


Assignment

Parallel


Purpose

Supportive care


Intervention(s) planned

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.


Inclusion criteria

  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

Exclusion criteria

  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.


Primary outcome(s)

  1. A mean reduction in body weight in the test group compared to the control 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)


Secondary outcome

  1. Mean reduction of systolic (SBP) and diastolic blood pressure (DBP)
  2. BMI
  3. Waist circumference (WC)
  4. Hip circumference (HC)
  5. Fasting blood glucose
  6. Serum ALT level
  7. Total and LDL cholesterol
  8. Mean increment of HDL cholesterol level

For the intervention group only:

  1. Qualitative assessment of the knowledge, perception, and attitudes (KPA) regarding the ‘plate model’ diet (1 hour focus group discussions and in-depth interviews)

Secondary outcome(s) - Time of assessment(s)

  1. Mean reduction of systolic (SBP) and diastolic blood pressure (DBP)
  2. BMI
  3. Waist circumference (WC)
  4. Hip circumference (HC)
  5. Fasting blood glucose
  6. Serum ALT level
  7. Total and LDL cholesterol
  8. Mean increment of HDL cholesterol level

For the intervention group only:

  1. Qualitative assessment of the knowledge, perception, and attitudes (KPA) regarding the ‘plate model’ diet (1 hour focus group discussions and in-depth interviews)


Target number/sample size

120 (60 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-11-01


Anticipated end date

2017-04-30


Recruitment status

Recruiting


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)


Funding source

None



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr.Ranil Jayawardena MBBS, MSc, PhD.
Senior Lecturer
Department of Physiology, Faculty of Medicine, University of Colombo, 25 Kynsey Road, Colombo 8, Sri Lanka
Tel: 0094 11 2695300 [Ext: 203/204/205]
Mob: 0718323332
Fax: 0094 11 2691581
ranil7@gmail.com

Contact Person for Public Queries

Dr.Pasindu Fernando MBBS
Research Assistant
Institute of Cardiology, National Hospital of Sri Lanka, Kynsey Road, Colombo 8, Sri Lanka
Tel: (941) 691407, (941) 693040, (941) 693039
Mob: 0718732393
Fax: (941) 691407
pasindu9091@gmail.com


Primary study sponsor/organization

Institute of Cardiology, National Hospital of Sri Lanka

Kynsey Road, Colombo 8, Sri Lanka
Tel: 0094112691111 [ Ext: 2842]


Secondary study sponsor (If any)

None