Appendix Table 1.
Primary and Secondary Outcomes Associated with Percent Weight Change, Stratified by Randomization Group
| Weight Change Groups (percent weight loss in first year) | |||||
| ILI Group |
Gain /Stable (<2% loss) |
Small Loss (2 to 5%) |
Medium Loss (5 to 10%) |
Large Loss (≥10%) |
Test for Trend |
| Primary Outcome | |||||
| Events / person years | 58 / 3096 | 69 / 3766 | 114 / 6446 | 120 / 8257 | |
| Crude rate/100 person years | 1.87 | 1.83 | 1.77 | 1.45 | |
| Unadjusted HR (95% C.I.) | REF | 0.94 (0.66 – 1.33) | 0.91 (0.66 – 1.25) | 0.72 (0.52 – 0.99)* | 0.03 |
| Adjusted HR ǂ (95% C.I.) | REF | 0.78(0.54 – 1.13) | 0.89 (0.63 – 1.25) | 0.61 (0.44 – 0.86)* | 0.007 |
| Secondary Outcome | |||||
| Events / person years | 82 / 3018 | 108 / 3643 | 151 / 6335 | 173 / 8127 | |
| Crude rate/100 person years | 2.72 | 2.96 | 2.38 | 2.13 | |
| Unadjusted HR (95% C.I.) | REF | 1.04 (0.78 – 1.39) | 0.84 (0.64 – 1.10) | 0.73 (0.56 – 0.96)* | 0.003 |
| Adjusted HR ǂ (95% C.I.) | REF | 0.90 (0.67 – 1.22) | 0.79 (0.59 – 1.05) | 0.61 (0.45 – 0.80)* | <0.0001 |
| Weight Change Groups (percent weight loss in first year) | |||||
| DSE Group |
Gain /Stable (<2% loss) |
Small Loss (2 to 5%) |
Medium Loss (5 to 10%) |
Large Loss (≥10%) |
Test for Trend |
| Primary Outcome | |||||
| Events / person years | 231 / 13978 | 72 / 4104 | 40 / 2124 | 8 / 685 | |
| Crude rate/100 person years | 1.65 | 1.75 | 1.88 | 1.17 | |
| Unadjusted HR (95% C.I.) | REF | 1.10 (0.84 – 1.43) | 1.16 (0.82 – 1.62) | 0.72 (0.35 – 1.45) | 0.82 |
| Adjusted HR ǂ (95% C.I.) | REF | 1.17 (0.89 – 1.54) | 1.26 (0.88 – 1.79) | 0.71 (0.33 – 1.51) | 0.51 |
| Secondary Outcome | |||||
| Events / person years | 340 / 13681 | 98 / 4014 | 52 / 2076 | 13 / 665 | |
| Crude rate/100 person years | 2.49 | 2.44 | 2.50 | 1.95 | |
| Unadjusted HR (95% C.I.) | REF | 1.02 (0.81 – 1.27) | 1.03 (0.77 – 1.38) | 0.80 (0.46 – 1.40) | 0.76 |
| Adjusted HR ǂ (95% C.I.) | REF | 1.01 (0.79 – 1.27) | 0.99 (0.73 – 1.35) | 0.77 (0.42 – 1.42) | 0.67 |
ǂ
adjusted for sex, age, baseline weight(percent weight loss models), baseline fitness (fitness change models),CVD history, insulin use, diabetes duration, smoking status, LDL, SBP, DBP. Primary Outcome: (non-fatal MI, stroke, hospitalized angina, CVD death); Secondary Outcome: (non-fatal MI, stroke, hospitalized angina, CABG/PTCA, hospitalized CHF, carotid endarterectomy, PVD, total mortality)