Table 4.
Physiologic Outcome | Estimated mean difference at baseline | Estimated mean difference at 3 months | Estimated mean difference at 6 months | Treatment × Time interaction | ||||||
---|---|---|---|---|---|---|---|---|---|---|
INT-Control | 95% Confidence Interval | p-value | INT-Control | 95% Confidence Interval | p-value | INT-Control | 95% Confidence Interval | p-value | p-value | |
A1c (%) | 0.01 | -0.27, 0.29 | 0.94 | -0.12 | -0.40, 0.17 | 0.42 | -0.29 | -0.58, 0.0002 | 0.05 | 0.15 |
Fasting glucose (mg/dl) | -0.56 | -11.07, 9.95 | 0.92 | -8.26 | -18.89, 2.36 | 0.13 | -3.96 | -14.72, 6.81 | 0.47 | 0.42 |
LDL (mg/dl) | -1.43 | -10.42, 7.57 | 0.76 | -6.02 | -14.92, 2.88 | 0.19 | -5.55 | -14.56, 3.46 | 0.23 | 0.42 |
HDL (mg/dl) | 3.28 | -0.19, 6.76 | 0.06 | 1.96 | -1.53, 5.44 | 0.27 | 3.77 | 0.26, 7.27 | 0.04 | 0.25 |
Triglycerides (mg/dl) | 2.21 | -20.73, 25.15 | 0.85 | -10.23 | -33.27, 12.81 | 0.38 | -2.12 | -25.37, 21.12 | 0.86 | 0.38 |
Systolic BP (mmHg) | -3.55 | -8.19, 1.10 | 0.14 | -2.88 | -7.56, 1.81 | 0.23 | -1.86 | -6.62, 2.90 | 0.44 | 0.79 |
Diastolic BP (mmHg) | -0.26 | -2.70, 2.19 | 0.84 | -1.00 | -3.47, 1.46 | 0.42 | -0.23 | -2.73, 2.27 | 0.86 | 0.79 |
Weight (kg) | -3.42 | -8.46, 1.62 | 0.18 | -3.66 | -8.70, 1.38 | 0.16 | -3.26 | -8.31, 1.78 | 0.21 | 0.65 |
Body Mass Index(kg/m2) | -1.26 | -2.99, 0.47 | 0.16 | -1.33 | -3.06, 0.40 | 0.13 | -1.19 | -2.92, 0.54 | 0.18 | 0.65 |
Waist Circumference (in) | -0.92 | -2.53, 0.69 | 0.26 | -1.01 | -2.62, 0.60 | 0.22 | -0.80 | -2.42, 0.82 | 0.33 | 0.86 |
Random intercept model with fixed effects of time, treatment group, stratum, and interactions of fixed effects, adjusting for age group and marital status. Statistical significance of main effects and treatment by time interaction assess using Wald statistic. Mean differences (INT-Control) at 3 and 6 months were estimated using linear contrasts.