Table 3.
Changes in BMI (baseline versus 24 weeks) in the ITT set.
| BMI, kg/m2 | Intervention group | Control group | Between groups P value | |
| Baseline |
|
|
|
|
|
|
n | 212 | 209 | |
| Mean (SD) | 29.42 (3.53) | 29.40 (3.39) | ||
| Median | 28.70 | 28.90 | ||
| Min, max | 24.90, 46.80 | 24.90, 41.80 | ||
| Week 12 |
|
|
|
|
|
|
n | 196 | 179 | |
| Mean (SD) | 28.35 (3.25) | 28.59 (2.84) | ||
| Median | 27.85 | 28.10 | ||
| Min, max | 22.10, 40.10 | 24.00, 38.90 | ||
| Week 24 |
|
|
|
|
|
|
n | 196 | 181 | |
| Mean (SD) | 28.33 (3.46) | 28.74 (2.88) | ||
| Median | 27.55 | 28.20 | ||
| Min, max | 22.60, 41.40 | 23.90, 39.70 | ||
| Change W24 a |
|
|
|
|
|
|
n | 196 | 181 | |
| Mean (SD) | -0.83 (1.31) | -0.28 (1.03) | <.001b | |
| Median | -0.80 | -0.20 | ||
| Min, max | -5.80, 2.20 | -6.70, 2.40 | ||
| Within the group P value |
|
<.001c | <.001c | |
aChange W24=week 24−baseline
bANCOVA using the site and baseline weight as covariates
cPaired t test