Screening | Randomisation | Post-randomisation | Exit | |||||||
---|---|---|---|---|---|---|---|---|---|---|
1st | 2nd | |||||||||
Timepoint [months] | 4 | 6 | 12 | 24 | 36 | 40 | 46 | |||
Registration | x | |||||||||
Eligibility screen | x | x | x | |||||||
Informed consent | x | x | ||||||||
Fasting plasma glucose | x | x | x | x | x | x | x | x | ||
HbA1c | x | x | x | x | x | x | x | x | ||
Fasting lipid profile | x | x | x | x | x | x | x | |||
Fasting plasma insulin | x | x | x | x | x | x | x | |||
HOMA IR | x | x | x | x | x | x | x | |||
Blood pressure | x | x | x | x | x | x | x | |||
Height | x | |||||||||
Weight | x | x | x | x | x | x | x | x | x | |
BMI | x | x | x | x | x | x | x | x | x | |
Waist circumference | x | x | x | x | x | x | x | x | x | |
Body fat mass | x | x | x | x | x | x | x | x | x | |
Body fat % | x | x | x | x | x | x | x | x | x | |
Accelerometerb | x | x | x | x | x | x | x | x |