Table 1.
Changes in weight (baseline versus 24 weeks) in the ITT set.
| Weight, kg | Intervention group | Control group | Between groups P value | |
| Baseline |
|
|
|
|
|
|
n | 212 | 209 | |
| Mean (SD) | 81.13 (14.77) | 79.74 (15.28) | ||
| Median | 79.85 | 76.90 | ||
| Min, max | 55.20, 144.00 | 54.00, 141.10 | ||
| Week 12 |
|
|
|
|
|
|
n | 196 | 179 | |
| Mean (SD) | 77.85 (13.46) | 76.67 (13.26) | ||
| Median | 76.85 | 74.10 | ||
| Min, max | 49.80, 135.70 | 53.40, 118.10 | ||
| Week 24 |
|
|
|
|
|
|
n | 196 | 181 | |
| Mean (SD) | 77.87 (13.99) | 77.02 (13.33) | ||
| Median | 77.35 | 75.10 | ||
| Min, max | 50.10, 141.00 | 53.20, 117.90 | ||
| Change W24 a |
|
|
|
|
|
|
n | 196 | 181 | |
| Mean (SD) | -2.21 (3.60) | -0.77 (2.77) | <.001b | |
| Median | -2.10 | -0.70 | ||
| Min, max | -17.00, 5.60 | -20.40, 6.60 | ||
| Within group, P value | <.001c | <.001c | ||
aChange W24=week 24−baseline
bANCOVA using the site and baseline weight as covariates
cPaired t test