Study period | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post allocation | Close-out | ||||||||
Week | −1 to 0 | 0 ± 2 days | 2 ± 2 days | 4 ± 2 days | 6 ± 2 days | 8 ± 2 days | 24 ± 2 days | ||||
Time point | 1st visit | 2nd visit | 3rd visit | 4th visit | 5th visit | 6th visit | 7th visit | ||||
Enrollment: | × | ||||||||||
Eligibility screen | × | ||||||||||
Informed consent | × | ||||||||||
Allocation | × | ||||||||||
Intervention | × | × | × | × | × | × | × | × | × | × | |
Assessment | × | × | × | ||||||||
Baseline variables | × | × | × | ||||||||
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 application | × | × | × | × | × | × | × | × | × | × | × |
Evaluating the usability of the software | × | × | |||||||||
Evaluating the level of satisfaction of the software/application | × | × |