Table 3 Timing of study assessments
Screening | Visit 1 baseline | Visit 2 follow-up 1 | Visit 3 follow-up 2 | Visit 4 follow-up 3 | |
|---|---|---|---|---|---|
Weeks from randomization | -2 | 0 | 24 | 48 | 76 |
Visit window in weeks | – | + 2 | +/− 2 | +/− 2 | +/− 2 |
Informed consent | X | ||||
Demographics | X | ||||
Inclusion/exclusion criteria | X | X | |||
Anthropometric measures | X | X | X | X | |
Clinical variables | X | X | X | X | |
Randomization | X | ||||
Lifestyle counseling | X | ||||
Lifestyle informative material | X | ||||
WBA training (only for intervention group) | X | ||||
Blood pressure | X | X | X | X | |
Registration of laboratory assays | X | X | X | X | |
LDCW | X | X | X | X | |
IPAQ (short form) | X | X | X | X | |
EQ-5D-5L | X | X | |||
PSQI | X | X | |||
Healthcare resource consumption | X | X | X | X | |
Events | |||||
Adverse events including hypoglycemia | X | X | X | X | |
New diagnoses | X | X | X | X | |
Intervention compliance check | X | X | X | ||
Trial completion | X | ||||