Study period | |||||||
---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post-allocation | Close-out | ||||
Week | 0 ± 2 days | 0 ± 2 days | 2 ± 2 days | 4 ± 2 days | 6 ± 2 days | 8 ± 2 days | 24 ± 2 days |
Visit | 1st visit | 2nd visit | 3rd visit | 4th visit | 5th visit | 6th visit | 7th visit |
Assessment of inclusion criteria and sampling | × | ||||||
Attainment of informed consent | × | ||||||
Baseline assessment | × | ||||||
Formation of two groups: intervention and control | × | ||||||
The intervention | × | × | × | × | × | × | |
Measuring adherence to treatment | × | × | × | ||||
Measuring adherence to the diet | × | × | × | ||||
Evaluating the predisposing, enabling, and reinforcing factors of adherence | × | × | × | ||||
Measurement of systolic and diastolic BP, waist circumference, and BMI | × | × | × | × | × | × | × |
Evaluating the regular monitoring of BP by the mobile app | × | × | × | × | × | × | × |
Evaluating the usability of the software | × | × | |||||
Evaluating the level of satisfaction of the software/application | × | × |