| Number of clusters | Number of participants | Baseline Mean (SD) | 6-month follow-up Mean (SD) | Mean change from baseline to 6 months (SD) | SHIFT vs. control at 6 months | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Control | SHIFT | Control | SHIFT | Control | SHIFT | Control | SHIFT | Control | SHIFT | Adjusted mean difference (95% CI)a | p-value | |
Primary analysis (complete case)b | 13 | 12 | 119 | 90 | 8932 (2922) | 9355 (3305) | 8216 (2767) | 9387 (3455) | − 716 (2109) | 32 (2939) | 1008 (145, 1871) | 0.022 |
Intention to treatb | ||||||||||||
 Multiple imputation c | 13 | 12 | 199 | 183 | – | – | – | – | – | – | 335 (− 471, 1141) | 0.414 |
 Worst case scenario d | 13 | 12 | 199 | 183 | 8788 (2843) | 9394 (3134) | 8244 (2270) | 8846 (2527) | − 544 (2499) | − 548 (3056) | 399 (− 129, 927) | 0.139 |
 Best case scenario e | 13 | 12 | 199 | 183 | 8788 (2843) | 9464 (3127) | 8244 (2270) | 9344 (2466) | − 543 (2499) | − 120 (2985) | 868 (398, 1338) | < 0.001 |
Sensitivity analyses—effect of number of valid activPAL days (complete-case): | ||||||||||||
 ≥ 2 days | 13 | 12 | 118 | 88 | 8960 (2919) | 9427 (3291) | 8238 (2768) | 9411 (3488) | − 722 (2117) | − 16 (2949) | 981 (102, 1860) | 0.029 |
 ≥ 3 days | 13 | 12 | 116 | 87 | 8925 (2921) | 9459 (3296) | 8278 (2770) | 9456 (3484) | − 647 (2015) | − 4 (2963) | 906 (27, 1784) | 0.043 |
 ≥ 4 days | 13 | 12 | 113 | 79 | 8832 (2877) | 9385 (3290) | 8179 (2710) | 9480.69 (3509) | − 653 (2020) | 96 (3028) | 973 (76, 1870) | 0.034 |