Items | Screening | Post-allocation | 3Â months after the trial | ||||||
---|---|---|---|---|---|---|---|---|---|
Visit 1 (day − 7 to − 2) | Visit 2 (day 0) | Visit 3 (week 1) | Visit 4 (week 2) | Visit 5 (week 3) | Visit 6 (week 4) | Visit 7 (week 8) | Visit 8 (week 12) | Visit 9 (week 24) | |
Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â |
Inclusion/exclusion criteria | X | Â | Â | Â | Â | Â | Â | Â | Â |
Randomization | Â | X | Â | Â | Â | Â | Â | Â | Â |
Intervention | Â | X | X | X | X | X | X | X | Â |
Basic informationa | X | Â | Â | Â | Â | Â | Â | Â | Â |
Body measurementb | X | X | X | X | X | X | X | X | X |
Vital signs | X | X | X | X | X | X | X | X | X |
Medical historyc | X | Â | Â | Â | Â | Â | Â | Â | Â |
General physical examination | X | Â | Â | Â | Â | Â | Â | X | X |
Compliance monitoring | Â | Â | Â | X | Â | Â | Â | Â | Â |
Healthy behaviors | X | Â | Â | Â | Â | Â | Â | X | X |
Readmission rate | Â | Â | Â | Â | Â | Â | Â | X | X |
Anxiety | X | Â | Â | Â | Â | Â | Â | X | X |
Psychological capital | X | Â | Â | Â | Â | Â | Â | X | X |
Subjective well-being | X | Â | Â | Â | Â | Â | Â | X | X |
Clinical indicatorsd | X | Â | Â | Â | Â | Â | Â | X | X |
Adverse event monitoring | Â | Â | X | X | X | X | X | X | X |