Table 1.
Assessments | Study visits | ||
---|---|---|---|
Screening | Baseline | 6-monthly (until 2 years from baseline) | |
Informed consent | ✓ | ||
Demographics characteristics | ✓ | ||
Systolic and diastolic blood pressuresa | ✓ | ✓ | ✓ |
Current blood pressure medications | ✓ | ||
Socioeconomic characteristics | ✓ | ||
Medical history | ✓ | ||
Concomitant medications | ✓ | ✓ | |
Family medical history | ✓ | ||
Tobacco smoking status | ✓ | ✓ | |
International physical activity questionnaire | ✓ | ✓ | |
Dietary questionnaire | ✓ | ✓ | |
EQ-5D-5L questionnaire | ✓ | ✓b | |
MMAS-8 for antihypertensive medication adherence | ✓ | ✓ | |
MMAS-8 for statins adherence | ✓ | ||
Adiposity measures (BMI, waist circumference) | ✓ | ✓ | |
Laboratory tests | ✓ | ✓b | |
Serum creatinine | |||
Fasting blood glucose | |||
Total cholesterol | |||
High density lipoprotein cholesterol | |||
Low density lipoprotein cholesterol | |||
Triglycerides | |||
Urine spot albumin | |||
Urine spot sodium | |||
Urine spot creatinine | |||
Adverse/serious adverse events | ✓ | ✓ | |
Death | ✓ |
aOnly measurements taken by independent assessors who will be masked to randomization will be used for the analysis
bTo be assessed only at final follow-up visit