Two-way table of predicted means (SEM) of time and group using ITT and the PPS
| Control | Intervention | Difference | p Value | |
|---|---|---|---|---|
| PPS | ||||
| Weight (kg) | ||||
| Baseline | 87.81 (1.36) | 87.52 (1.36) | −0.29 | 0.880 |
| 12 months | 88.10 (1.36) | 86.68 (1.36) | −1.42 | 0.461 |
| Difference | 0.29 | −0.84 | −1.13 | |
| p Value | 0.378 | 0.012 | 0.016* | |
| Waist (cm) | ||||
| Baseline | 102.55 (1.07) | 102.39 (1.07) | −0.16 | 0.914 |
| 12 months | 102.99 (1.07) | 101.48 (1.07) | −1.51 | 0.318 |
| Difference | 0.45 | −0.90 | −1.35 | |
| p Value | 0.345 | 0.057 | 0.044* | |
| FPG (mmol/L) | ||||
| Baseline | 5.09 (0.05) | 5.16 (0.05) | 0.06 | 0.381 |
| 12 months | 5.15 (0.05) | 5.22 (0.05) | 0.07 | 0.321 |
| Difference | 0.06 | 0.07 | 0.01 | |
| p Value | 0.231 | 0.170 | 0.903* | |
| OGTT 2 h glucose | ||||
| Baseline | 6.19 (0.16) | 6.19 (0.16) | 0.00 | 0.993 |
| 12 months | 6.11 (0.16) | 6.06 (0.16) | −0.05 | 0.822 |
| Difference | −0.08 | −0.13 | −0.05 | |
| p Value | 0.566 | 0.347 | 0.802* | |
| Systolic (mm Hg) | ||||
| Baseline | 139.89 (1.51) | 144.14 (1.51) | 4.25 | 0.049 |
| 12 months | 137.75 (1.51) | 136.83 (1.51) | −0.92 | 0.666 |
| Difference | −2.14 | −7.31 | −5.17 | |
| p Value | 0.198 | <0.001 | 0.028* | |
| Diastolic (mm Hg) | ||||
| Baseline | 80.71 (0.98) | 81.39 (0.98) | 0.68 | 0.623 |
| 12 months | 79.03 (0.98) | 76.47 (0.98) | −2.56 | 0.065 |
| Difference | −1.68 | −4.92 | −3.24 | |
| p Value | 0.111 | <0.001 | 0.030* | |
| Total cholesterol (mmol/L) | ||||
| Baseline | 5.22 (0.09) | 5.19 (0.09) | −0.03 | 0.813 |
| 12 months | 5.26 (0.09) | 5.08 (0.09) | −0.18 | 0.172 |
| Difference | 0.04 | −0.11 | −0.15 | |
| p Value | 0.581 | 0.140 | 0.152* | |
| Triglycerides (mmol/L) | ||||
| Baseline | 1.44 (0.05) | 1.36 (0.05) | −0.08 | 0.277 |
| 12 months | 1.58 (0.05) | 1.44 (0.05) | −0.14 | 0.054 |
| Difference | 0.15 | 0.08 | −0.06 | |
| p Value | <0.001 | 0.037 | 0.263* | |
| LDL-cholesterol (mmol/L) | ||||
| Baseline | 3.01 (0.08) | 3.08 (0.08) | 0.07 | 0.571 |
| 12 months | 3.00 (0.08) | 2.90 (0.08) | −0.10 | 0.384 |
| Difference | −0.01 | −0.18 | −0.17 | |
| p Value | 0.881 | 0.008 | 0.075* | |
| HDL-cholesterol (mmol/L) | ||||
| Baseline | 1.52 (0.04) | 1.49 (0.04) | −0.03 | 0.596 |
| 12 months | 1.53 (0.04) | 1.52 (0.04) | −0.01 | 0.856 |
| Difference | 0.01 | 0.03 | 0.02 | |
| p Value | 0.498 | 0.081 | 0.448* | |
| Framingham 5-year CVD risk (%) | ||||
| Baseline | 8.35 (0.54) | 9.72 (0.54) | 1.37 | 0.075 |
| 12 months | 8.46 (0.54) | 8.75 (0.54) | 0.29 | 0.704 |
| Difference | 0.11 | −0.97 | −1.08 | |
| p Value | 0.712 | 0.002 | 0.013* | |
| ITT | ||||
| Weight (kg) | ||||
| Baseline | 87.35 (1.24) | 86.53 (1.20) | −0.82 | 0.636 |
| 12 months | 87.61 (1.25) | 85.95 (1.20) | −1.67 | 0.337 |
| Difference | 0.26 | −0.59 | −0.85 | |
| p Value | 0.451 | 0.079 | 0.079* | |
| Waist (cm) | ||||
| Baseline | 102.46 (0.97) | 101.72 (0.94) | −0.74 | 0.584 |
| 12 months | 102.87 (0.99) | 101.13 (0.95) | −1.74 | 0.205 |
| Difference | 0.41 | −0.59 | −1.00 | |
| p Value | 0.379 | 0.187 | 0.122* | |
| FPG (mmol/L) | ||||
| Baseline | 5.07 (0.05) | 5.14 (0.04) | 0.06 | 0.328 |
| 12 months | 5.14 (0.05) | 5.19 (0.05) | 0.04 | 0.514 |
| Difference | 0.07 | 0.05 | 0.02 | |
| p Value | 0.122 | 0.236 | 0.763* | |
| OGTT 2 h glucose (mmol/L) | ||||
| Baseline | 6.18 (0.15) | 6.19 (0.14) | 0.00 | 0.983 |
| 12 months | 6.12 (0.15) | 5.97 (0.15) | −0.16 | 0.452 |
| Difference | −0.06 | −0.22 | −0.16 | |
| p Value | 0.668 | 0.083 | 0.377* | |
| Systolic BP (mm Hg) | ||||
| Baseline | 140.23 (1.39) | 143.00 (1.34) | 2.77 | 0.152 |
| 12 months | 137.57 (1.45) | 136.34 (1.40) | −1.22 | 0.544 |
| Difference | −2.66 | −6.65 | −3.99 | |
| p Value | 0.091 | <0.001 | 0.068* | |
| Diastolic BP (mm Hg) | ||||
| Baseline | 80.89 (0.90) | 81.33 (0.87) | 0.44 | 0.725 |
| 12 months | 78.65 (0.94) | 76.32 (0.91) | −2.33 | 0.076 |
| Difference | −2.24 | −5.01 | −2.77 | |
| p Value | 0.025 | <0.001 | 0.046* | |
| Total cholesterol (mmol/L) | ||||
| Baseline | 5.23 (0.09) | 5.21 (0.09) | −0.02 | 0.877 |
| 12 months | 5.28 (0.09) | 5.14 (0.09) | −0.14 | 0.263 |
| Difference | 0.05 | −0.07 | −0.12 | |
| p Value | 0.452 | 0.308 | 0.212* | |
| Triglycerides (mmol/L) | ||||
| Baseline | 1.43 (0.07) | 1.49 (0.07) | 0.06 | 0.506 |
| 12 months | 1.56 (0.07) | 1.53 (0.07) | −0.03 | 0.741 |
| Difference | 0.13 | 0.03 | 0.10 | |
| p Value | 0.004 | 0.436 | 0.125* | |
| LDL-cholesterol (mmol/L) | ||||
| Baseline | 3.02 (0.08) | 3.10 (0.07) | 0.07 | 0.486 |
| 12 months | 3.03 (0.08) | 2.94 (0.08) | −0.09 | 0.421 |
| Difference | 0.01 | −0.16 | −0.17 | |
| p Value | 0.927 | 0.011 | 0.068* | |
| HDL-cholesterol (mmol/L) | ||||
| Baseline | 1.52 (0.04) | 1.52 (0.04) | 0.00 | 0.951 |
| 12 months | 1.53 (0.04) | 1.55 (0.04) | 0.02 | 0.760 |
| Difference | 0.01 | 0.03 | 0.02 | |
| p Value | 0.601 | 0.053 | 0.336* | |
| Framingham 5-year CVD risk (%) | ||||
| Baseline | 8.20 (0.46) | 9.35 (0.44) | 1.15 | 0.072 |
| 12 months | 8.28 (0.45) | 8.40 (0.44) | 0.12 | 0.851 |
| Difference | 0.08 | −0.95 | −1.03 | |
| p Value | 0.782 | 0.001 | 0.011* | |
*p Value for the F-test of the time by group interaction.
BP, blood pressure; CVD, cardiovascular disease; FPG, fasting plasma glucose; HDL, high-density lipoprotein; ITT, intention to treat; LDL, low-density lipoprotein; OGTT, oral glucose tolerance test; PPS, per protocol set.