Table 4.

Cox Proportional Hazards Regression Estimates of differences in Primary and Secondary Outcome Hazards for year 1 weight and waist change categories for varying levels of covariate adjustment for Intensive Lifestyle Intervention.

Level of Adjustment	Decreased Weight/Waist	Weight Increase/ Waist Decrease HR(95%CI)	Weight Decrease/ Waist Increase HR(95%CI)	Increased Weight/Waist HR(95%CI)	Overall Type 3 P-value
Primary CVD Outcome*
Model 1	REF	0.64 (0.28, 1.44)	1.31 (0.94, 1.82)	1.41 (0.86, 2.30)	0.1386
Model 2	REF	0.75 (0.33, 1.70)	1.55 (1.11, 2.17)*	1.76 (1.07, 2.89)*	0.0096
Model 3	REF	0.58 (0.24, 1.41)	1.48 (1.05, 2.09)*	1.32 (0.77, 2.25)	0.0609
Secondary CVD Outcome**
Model 1	REF	0.95 (0.54, 1.66)	1.20 (0.90, 1.59)	1.70 (1.16, 2.50)*	0.0370
Model 2	REF	1.13 (0.64, 1.97)	1.42 (1.07, 1.89)*	2.17 (1.47, 3.20)*	0.0002
Model 3	REF	0.92 (0.50, 1.69)	1.43 (1.07, 1.92)*	1.80 (1.19, 2.74)*	0.0056

^*Note: indicates HR is statistically significantly different from reference group; Model 1 is adjusted for clinical site only; Model 2 is adjusted for sex, age, race, and clinical site; Model 3 is adjusted for sex, age, race, clinical site, cardiovascular disease history, insulin use, diabetes duration, weight, systolic blood pressure, diastolic blood pressure, LDL cholesterol, and smoking status