Do changes in lifestyle pattern including diet and exercise, reduce the risk of cardiovascular disease (CVD) in patients with metabolic syndrome?

The trial will be conducted in 3 arms: (A) Control arm with routine care (B) Intervention arm 1 with diet and lifestyle modification counselling (C) Intervention arm 2 with diet and lifestyle modification with peer support

All participants will undergo the following: 1. Routine care by relevant clinics - Medication, advice on diet/ exercise/ foot care etc. 2. Assessment of anthropometric measurements – weight, height, waist and hip circumferences 3. Assessment of blood pressure 4. Biochemical investigations – fasting blood sugar, HbA1c, lipid profile, SGOT,SGPT, CRP 5. Assessment of Knowledge, Attitudes and practices regarding CVDs through a questionnaire 6. Assessment of dietary practices - 3 day diet diary, Food Frequency Questionnaire 7. Assessment of activity level 8. All the participants will be reviewed every 2 months for assessment of anthropometry, diet and exercise until 6 months are completed 9. Biochemical tests will be repeated for all the participants after 6 months

(B) Intervention arm 1- in addition to above activities for all participants 1. Participants in this arm will undergo individual counselling for diet & exercise and a plan will be given at the beginning of the intervention after the pre-assessment 2. Review every 2 months for adjustments in diet & exercise plan

(C) Intervention arm 2- in addition to above activities for all participants 1. Participants in this arm will undergo group counselling for diet & exercise at the beginning of the intervention after the pre-assessment 2. Reading and completion of an activity booklet - including facts on CVD, general advice on lifestyle change during the intervention period This intervention arm will receive additional peer support including: 3. Recruitment and training of peer leaders 4. Discussions on chapters and individual recordings in activity book – led by peer leader + Dietician ( ½ hr per session for 4 pre-arranged dates/ clinic visits during study period) 5. Peer support activity 1 - Health message to be send via SMS by Peer leader “Tobacco use, an unhealthy diet, and physical inactivity increase the risk of heart attacks and strokes”( WHO) 6. Presentation by experts (Peer support activity 2 - “Discussion on challenges to make behavioural changes and how to overcome problems in behaviour change” and Peer support activity 3 - “How do I increase my activity level ? ”) 7. Peer support activity 4 - Health message to be send via SMS by Peer leader “Engaging in a suitable exercise for at least 30 minutes every day of the week will help to prevent heart attacks and strokes” (WHO) 8. Peer support activity 5 -“Planning for a healthy diet” - A video presentation / peer group discussion 9. Peer support activity 6 - Health message to be send via SMS by Peer leader “Eating at least five servings of fruit and vegetables a day, helps to prevent heart attacks and strokes” (WHO) 10. Peer support activity 7 - Health message to be send via SMS by Peer leader “Limiting your salt intake to less than one teaspoon a day, helps to prevent heart attacks and strokes” (WHO)

Participant characteristics: • 35-55 year old males and females • free living -- non- institutionalized • residents of Colombo district • attending the medical clinics at NHSL • with metabolic syndrome (1) Raised Triglycerides >150 mg/l (1.7 mmol/l) or specific treatment for hypertriglyceridaemia. (2) Low HDL-cholesterol <40 mg/l (1.03 mmol/l) in males and <50 mg/l (1.29 mmol/l) in females or specific treatment for low HDL-cholesterol. (3) Raised blood pressure: systolic blood pressure >130 mmHg or diastolic blood pressure >85 mmHg or treatment for previously diagnosed hypertension. (4) Dysglycaemia: fasting plasma glucose>100 mg/l (5.6 mmol/l) and/or 2 h post-oral glucose tolerance test glucose >7.8 mmol/l or previously diagnosed type-2 diabetes. (5) Central obesity - classified as waist circumference >90 cm for males and >80 cm for females Presence of central obesity together with any two of the above (1-4) parameters are defined to have metabolic syndrome. • The following parameters diagnosed within 5 years of duration - elevated blood glucose levels, elevated blood pressure, dyslipideamia Comment 1) Participants must have all of these conditions. 2) The participants are randomized. Therefore we assume the participants who have variations among the presence of the parameters of metabolic syndrome are equally distributed 3) Also even there are changes in these diseases which are considered as cardiovascular risk factors, modification of diet and exercise which can be practiced in clinic setup is more or less same. 4) Since we are studying the overall cardiovascular risk, minor differences will not be of major significance. 5) Individual conditions are not considered as outcome indicators.

Patients who are having • CVD events – Ischemic heart diseases, • past history of hospitalization due to CVDs, • renal dysfunction (Acute or Chronic renal failure) • Chronic diseases, • pregnant & lactating or planning for pregnancy, • non ambulatory to be excluded by interviewing & examination of clinic records