Control group N = 89 | Intervention group N = 77 | Mean difference 95% CI | p value | |
---|---|---|---|---|
Primary analysis | ||||
Multiple imputation (N = 166) | − 4.9 [− 7.4;− 2.5] | < 0.001 | ||
Sensitivity analyzes | ||||
Complete cases (N = 144, 86.7%) | 6.4 [5–11.2] kg | 1.4 [1–4.5] kg | − 5.1 CI95 [− 7.4;− 2.8] | < 0.001 |
Worst case imputation (N = 166) | 4.5 [− 1.5;10.5] kg | 1.5 [− 2;7.7] kg | − 0.5 [− 3.2;2.3] | 0.7 |
Last observation carried forward (N = 166) | 7 [2;15.5] kg | 1.5 [− 2;7.7] kg | − 8.4 [− 16.6;− 0.2] | 0.047 |
Per protocol (N = 135, 81.3%) | 5 [0.5;11.3] kg | 1 [− 2.0;4.6] kg | − 4.7 [− 7.1;− 2.3] | < 0.001 |