Study period | Screening | Intervention period | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Visit (V) | V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | V10 |
Study week | −1 (±2 days) | Randomization | 1 (±2 days) | 2 (±2 days) | 3 (±2 days) | 4 (±2 days) | 5 (±2 days) | 6 (±2 days) | 7 (±2 days) | 8 (±2 days) |
Telephone visit |  |  | √ |  | √ |  | √ |  | √ |  |
Screening/demography/baseline | ||||||||||
 Written informed consent | √ |  |  |  |  |  |  |  |  |  |
 Inclusion/exclusion criteria | √ | √ |  |  |  |  |  |  |  |  |
 Demographics | √ |  |  |  |  |  |  |  |  |  |
 Physical examination, height, and weight | √ |  |  |  |  |  |  |  |  |  |
 Medical/ current conditions | √ |  |  |  |  |  |  |  |  |  |
 History of diabetes and complications | √ |  |  |  |  |  |  |  |  |  |
Intervention | ||||||||||
 Instruction of diet and exercises |  | √ | √ | √ | √ | √ | √ | √ | √ |  |
 Vital signs (blood pressure, heart rate) | √ | √ |  |  |  |  |  |  |  | √ |
 Body weight | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Waist circumference, hip circumference | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Body fat percentage, lean body mass |  | √ |  |  |  |  |  |  |  | √ |
 Hematology panel |  | √ |  |  |  |  |  |  |  | √ |
 Urinalysis |  | √ |  |  |  |  |  |  |  | √ |
 Liver function |  | √ |  |  |  |  |  |  |  | √ |
 Creatinine, uric acid |  | √ |  |  |  |  |  |  |  | √ |
 Lipids |  | √ |  |  |  |  |  |  |  | √ |
 Glucose, insulin |  | √ |  |  |  |  |  |  |  | √ |
 Adverse events |  | √ | √ | √ | √ | √ | √ | √ | √ | √ |
 Diet management knowledge |  |  |  |  |  |  |  |  |  | √ |
 Self-efficacy scale |  | √ |  |  |  |  |  |  |  | √ |