Completers | All starters (dropouts imputed)d | ||||||||
---|---|---|---|---|---|---|---|---|---|
N | 1 year Mean ± SE | Unadjusted | Adjusted for baselinec | Unadjusted | |||||
Difference (SD) or ± SE | Significancee | Difference ± SE | Significancee | 1 year Mean ± SE | Difference ± SE | Significancee | |||
∆Weight-clinic (kg) | |||||||||
CCI-all educationa | 184 | 101.2 ± 1.6 | − 14.2 (10.3) | < 10−16 | − 13.8 ± 0.6 | < 10−16 | 102.7 ± 1.5 | − 13.8 ± 0.7 | < 10−16 |
Usual carea | 69 | 106.8 ± 2.7 | 0.04 (5.9) | 0.95 | − 1.1 ± 1.1 | 0.29 | 107.3 ± 2.6 | − 0.2 ± 0.8 | 0.85 |
CCI-all vs. usual careb | − 14.3 ± 1.0 | < 10−16 | − 12.7 ± 1.3 | < 10−16 | − 13.7 ± 1.1 | < 10−16 | |||
∆Hemoglobin A1c (%) | |||||||||
CCI-all educationa | 204 | 6.20 ± 0.07 | − 1.29 (1.32) | < 10−16 | − 1.32 ± 0.09 | < 10−16 | 6.29 ± 0.07 | − 1.30 ± 0.09 | < 10−16 |
Usual carea | 72 | 7.94 ± 0.22 | 0.20 (1.35) | 0.21 | 0.22 ± 0.16 | 0.17 | 7.84 ± 0.19 | 0.20 ± 0.15 | 0.18 |
CCI-all vs. usual careb | − 1.49 ± 0.18 | 4.4 × 10−16 | − 1.54 ± 0.19 | 4.4 × 10−16 | − 1.50 ± 0.17 | < 10−16 | |||
∆Systolic blood pressure (mmHg) | |||||||||
CCI-all educationa | 187 | 126 ± 1 | − 7 (16) | 1.3 × 10−8 | − 7 ± 1 | 1.6 × 10−7 | 126 ± 1 | − 6 ± 1 | 1.3 × 10−8 |
Usual carea | 67 | 129 ± 2 | 0 (18) | 0.91 | 0 ± 2 | 0.83 | 129 ± 2 | − 1 ± 2 | 0.67 |
CCI-all vs. usual careb | − 7 ± 2 | 0.005 | − 6 ± 3 | 0.02 | − 5 ± 2 | 0.02 | |||
∆Diastolic blood pressure (mmHg) | |||||||||
CCI-all educationa | 187 | 78 ± 1 | − 4 (9) | 1.4 × 10−7 | − 4 ± 1 | 6.2 × 10−7 | 79 ± 1 | − 4 ± 1 | 7.2 × 10−8 |
Usual carea | 67 | 81 ± 1 | 0 (10) | 0.92 | 0 ± 1 | 0.75 | 81 ± 1 | − 1 ± 1 | 0.45 |
CCI-all vs. usual careb | − 3 ± 1 | 0.01 | − 3 ± 1 | 0.03 | − 3 ± 1 | 0.06 | |||
∆ApoB (mg dL−1) | |||||||||
CCI-all educationa | 186 | 103 ± 2 | − 1 (24) | 0.69 | − 0 ± 2 | 0.82 | 104 ± 2 | − 2 ± 2 | 0.37 |
Usual carea | 59 | 107 ± 5 | 2 (37) | 0.75 | 1 ± 4 | 0.9 | 106 ± 4 | 0 ± 4 | 0.95 |
CCI-all vs. usual careb | − 2 ± 5 | 0.66 | − 1 ± 5 | 0.83 | − 2 ± 5 | 0.67 | |||
∆ApoA1 (mg dL−1) | |||||||||
CCI-all educationa | 185 | 160 ± 3 | 14 (24) | 8.9 × 10−16 | 14 ± 2 | 4.4 × 10−16 | 160 ± 2 | 14 ± 2 | < 10−16 |
Usual carea | 59 | 145 ± 3 | − 3 (19) | 0.18 | − 2 ± 3 | 0.55 | 147 ± 3 | − 2 ± 3 | 0.37 |
CCI-all vs. usual careb | 18 ± 3 | 4.7 × 10−9 | 16 ± 4 | 2.2 × 10−5 | 17 ± 3 | 1.4 × 10−7 | |||
∆ApoB/ApoA1 | |||||||||
CCI-all educationa | 185 | 0.67 ± 0.02 | − 0.06 (0.17) | 1.8 × 10−6 | − 0.06 ± 0.02 | 0.003 | 0.67 ± 0.02 | − 0.07 ± 0.01 | 1.9 × 10−7 |
Usual carea | 59 | 0.76 ± 0.04 | 0.03 (0.29) | 0.42 | 0.02 ± 0.03 | 0.5 | 0.74 ± 0.03 | 0.02 ± 0.03 | 0.58 |
CCI-all vs. usual careb | − 0.09 ± 0.04 | 0.02 | − 0.08 ± 0.03 | 0.02 | − 0.09 ± 0.03 | 0.01 | |||
∆Triglycerides (mg dL−1) | |||||||||
CCI-all educationa | 186 | 151 ± 11 | − 49 (168) | 5.6 × 10−5 | − 50 ± 16 | 0.001 | 148 ± 12 | − 48 ± 13 | < 10−16 |
Usual carea | 59 | 327 ± 65 | 30 (301) | 0.44 | 31 ± 29 | 0.27 | 305 ± 48 | 28 ± 32 | 0.43 |
CCI-all vs. usual careb | − 80 ± 41 | 0.05 | − 81 ± 33 | 0.02 | − 76 ± 35 | 9.9 × 10−7 | |||
∆LDL-C (mg dL−1) | |||||||||
CCI-all educationa | 172 | 111 ± 3 | 11 (32) | 7.7 × 10−6 | 11 ± 3 | 2.6 × 10−5 | 113 ± 3 | 10 ± 2 | 4.9 × 10−5 |
Usual carea | 48 | 90 ± 4 | − 11 (38) | 0.05 | − 11 ± 5 | 0.03 | 90 ± 5 | − 11 ± 5 | 0.02 |
CCI-all vs. usual careb | 22 ± 6 | 0.0003 | 22 ± 6 | 0.0002 | 21 ± 5 | 9.9 × 10−5 | |||
∆HDL-C (mg dL−1) | |||||||||
CCI-all educationa | 186 | 50 ± 1 | 8 (12) | < 10−16 | 7 ± 1 | < 10−16 | 50 ± 1 | 8 ± 1 | < 10−16 |
Usual carea | 59 | 35 ± 2 | − 2 (9) | 0.15 | − 1 ± 2 | 0.69 | 37 ± 2 | − 1 ± 1 | 0.41 |
CCI-all vs. usual careb | 9 ± 1 | 1.7 × 10−10 | 8 ± 2 | 9.9 × 10−6 | 9 ± 2 | 1.2 × 10−8 | |||
Triglycerides/HDL-C ratio | |||||||||
CCI-all educationa | 186 | 4.3 ± 0.6 | − 1.8 (9.4) | < 10−16 | − 1.9 ± 0.9 | < 10−16 | 4.1 ± 0.6 | − 1.6 ± 0.7 | < 10−16 |
Usual carea | 59 | 12.5 ± 2.7 | 0.9 (16.1) | 0.1 | 1.2 ± 1.6 | 0.16 | 11.2 ± 2.1 | 1.0 ± 1.7 | 0.24 |
CCI-all vs. usual careb | − 2.8 ± 2.2 | 3.1 × 10−10 | − 3.1 ± 1.8 | 5.5 × 10−7 | − 2.6 ± 1.8 | 4.5 × 10−9 | |||
∆Large VLDL-P (nmol L−1) | |||||||||
CCI-all educationA | 203 | 6 ± 1 | − 4 (7) | 5.6 × 10−15 | − 4 ± 1 | 1.6 × 10−14 | 6 ± 1 | − 4 ± 1 | 4.2 × 10−15 |
Usual carea | 68 | 12 ± 2 | 0 (8) | 0.71 | 0 ± 1 | 0.60 | 12 ± 1 | 0 ± 1 | 0.77 |
CCI-all vs. usual careb | − 3 ± 1 | 0.001 | − 3 ± 1 | 0.002 | 3 ± 1 | 0.0007 | |||
∆Total LDL-P (nmol L−1) | |||||||||
CCI-all educationa | 203 | 1234 ± 30 | − 62 (375) | 0.02 | − 57 ± 29 | 0.05 | 1235 ± 29 | − 64 ± 26 | 0.02 |
Usual carea | 68 | 1196 ± 60 | − 47 (491) | 0.43 | − 67 ± 53 | 0.21 | 1231 ± 57 | − 57 ± 56 | 0.31 |
CCI-all vs. usual careb | − 15 ± 65 | 0.82 | 10 ± 62 | 0.87 | − 7 ± 62 | 0.91 | |||
∆Small LDL-P (nmol L−1) | |||||||||
CCI-all educationa | 203 | 614 ± 22 | − 164 (332) | 2.2 × 10−12 | − 161 ± 24 | 4.1 × 10−11 | 613 ± 21 | − 161 ± 23 | 1.2 × 10−12 |
Usual carea | 68 | 724 ± 44 | 25 (370) | 0.57 | 16 ± 45 | 0.71 | 740 ± 41 | 18 ± 42 | 0.67 |
CCI-all vs. usual careb | − 189 ± 51 | 0.0002 | − 177 ± 52 | 0.0007 | − 179 ± 48 | 0.0002 | |||
∆LDL-particle size (nm) | |||||||||
CCI-all educationa | 201 | 20.53 ± 0.04 | 0.23 (0.54) | 1.7 × 10−9 | 0.23 ± 0.04 | 8.9 × 10−9 | 20.53 ± 0.04 | 0.23 ± 0.04 | 6.0 × 10−10 |
Usual carea | 68 | 20.25 ± 0.07 | − 0.08 (0.53) | 0.24 | − 0.08 ± 0.07 | 0.25 | 20.25 ± 0.07 | − 0.07 ± 0.06 | 0.25 |
CCI-all vs. usual careb | 0.30 ± 0.07 | 4.4 × 10−5 | 0.31 ± 0.08 | 0.0002 | 0.30 ± 0.07 | 3.8 × 10−15 | |||
∆Total HDL-P (µmol L−1) | |||||||||
CCI-all educationa | 203 | 33.2 ± 0.5 | 1.5 (4.9) | 1.2 × 10−5 | 1.5 ± 0.4 | 2.1 × 10−5 | 32.8 ± 0.4 | 1.5 ± 0.3 | 5.6 × 10−6 |
Usual carea | 68 | 29.4 ± 0.8 | − 0.8 (4.7) | 0.15 | − 0.8 ± 0.6 | 0.23 | 29.2 ± 0.7 | − 0.7 ± 0.6 | 0.23 |
CCI-all vs. usual careb | 2.3 ± 0.7 | 0.0004 | 2.3 ± 0.7 | 0.003 | 2.2 ± 0.7 | 0.0008 | |||
∆Large HDL-P (µmol L−1) | |||||||||
CCI-all educationa | 203 | 5.3 ± 0.2 | 1.0 (2.2) | 2.5 × 10−11 | 1.0 ± 0.2 | 4.1 × 10−11 | 5.3 ± 0.2 | 1.0 ± 0.2 | 1.2 × 10−11 |
Usual carea | 68 | 3.9 ± 0.3 | 0.1 (1.6) | 0.69 | 0.2 ± 0.3 | 0.44 | 3.9 ± 0.3 | 0.1 ± 0.2 | 0.74 |
CCI-all vs. usual careb | 0.9 ± 0.3 | 0.0002 | 0.8 ± 0.3 | 0.01 | 0.9 ± 0.3 | 0.0004 | |||
∆LP-IR score | |||||||||
CCI-all educationa | 203 | 58 ± 2 | − 14 (18) | < 10−16 | − 14 ± 1 | < 10−16 | 58 ± 1 | − 14 ± 1 | < 10−16 |
Usual carea | 68 | 74 ± 2 | − 1 (16) | 0.73 | − 2 ± 2 | 0.41 | 75 ± 2 | − 1 ± 2 | 0.74 |
CCI-all vs. usual careb | − 13 ± 2 | 3.8 × 10−9 | − 12 ± 3 | 6.2 × 10−6 | − 13 ± 2 | 6.2 × 10−9 | |||
∆C-reactive protein (mg L−1) | |||||||||
CCI-all educationa | 193 | 5.7 ± 0.5 | − 3.3 (13.4) | < 10−8 | − 3.1 ± 1.0 | < 10−16 | 5.6 ± 0.6 | − 3.6 ± 1.1 | < 10−16 |
Usual carea | 70 | 10.4 ± 1.8 | 1.3 (13.3) | 0.94 | 0.9 ± 1.7 | 0.88 | 10.3 ± 1.6 | 1.3 ± 1.5 | 0.93 |
CCI-all vs. usual careb | − 4.7 ± 1.9 | 1.2 × 10−6 | − 4.0 ± 2.0 | 3.0 × 10−5 | − 4.9 ± 1.8 | 9.3 × 10−7 | |||
∆WBC (k mm−3) | |||||||||
CCI-all educationa | 204 | 6.5 ± 0.1 | − 0.7 (1.4) | 2.1 × 10−11 | − 0.7 ± 0.1 | 2.1 × 10−11 | 6.6 ± 0.1 | − 0.7 ± 0.1 | 3.2 × 10−11 |
Usual carea | 72 | 8.3 ± 0.3 | − 0.1 (1.6) | 0.76 | − 0.1 ± 0.2 | 0.74 | 8.1 ± 0.3 | − 0.1 ± 0.2 | 0.76 |
CCI-all vs. usual careb | − 0.6 ± 0.2 | 0.003 | − 0.6 ± 0.2 | 0.004 | − 0.6 ± 0.2 | 0.003 | |||
∆10-year ASCVD risk (%) | |||||||||
CCI-all educationa | 135 | 10.5 ± 0.7 | − 1.6 (5.4) | 0.0004 | − 1.5 ± 0.6 | 0.01 | 9.6 ± 0.5 | − 1.3 ± 0.3 | 4.9 × 10−5 |
Usual carea | 55 | 12.7 ± 1.5 | 1.4 (9.3) | 0.28 | 1.1 ± 1.0 | 0.27 | 12.9 ± 1.2 | 1.2 ± 0.9 | 0.17 |
CCI-all vs. usual careb | − 3.0 ± 1.3 | 0.03 | − 2.6 ± 1.2 | 0.03 | − 2.6 ± 1.0 | 0.008 | |||
∆CIMT-average (mm) | |||||||||
CCI-all educationa | 144 | 0.695 ± 0.009 | 0.002 (0.055) | 0.63 | 0.003 ± 0.004 | 0.45 | 0.685 ± 0.010 | 0.002 ± 0.004 | 0.65 |
Usual carea | 68 | 0.680 ± 0.013 | 0.004 (0.041) | 0.37 | 0.002 ± 0.006 | 0.74 | 0.680 ± 0.013 | 0.001 ± 0.006 | 0.87 |
CCI-all vs. usual careb | − 0.002 ± 0.007 | 0.74 | 0.001 ± 0.008 | 0.87 | 0.001 ± 0.007 | 0.88 | |||
∆Statin (%) | |||||||||
CCI-all educationa | 218 | 48.2 ± 3.4 | − 3.7 (34.4) | 0.12 | − 3.6 ± 2.4 | 0.13 | 46.7 ± 3.2 | − 3.3 ± 2.3 | 0.15 |
Usual carea | 73 | 64.4 ± 5.6 | 9.6 (37.9) | 0.03 | 9.5 ± 4.3 | 0.03 | 67.4 ± 5.4 | 8.8 ± 4.3 | 0.04 |
CCI-all vs. usual careb | − 13.3 ± 5.0 | 0.008 | − 13.2 ± 5.0 | 0.009 | − 12.1 ± 4.9 | 0.01 | |||
∆Any antihypertensive medication (%) | |||||||||
CCI-all educationa | 218 | 56.4 ± 3.4 | − 11.9 (42.3) | 3.2 × 10−5 | − 11.9 ± 2.9 | 3.6 × 10−5 | 55.8 ± 3.3 | − 11.4 ± 2.8 | 5.3 × 10−5 |
Usual carea | 73 | 60.3 ± 5.8 | 9.6 (41.4) | 0.05 | 9.6 ± 5.1 | 0.06 | 61.2 ± 5.6 | 8.3 ± 4.8 | 0.09 |
CCI-all vs. usual careb | − 21.5 ± 5.6 | 0.0002 | − 21.6 ± 6.0 | 0.0004 | − 19.7 ± 5.6 | 0.0004 | |||
∆ACE or ARB (%) | |||||||||
CCI-all educationa | 218 | 28.9 ± 3.1 | 0.9 (27.1) | 0.62 | 1.5 ± 1.9 | 0.42 | 30.0 ± 2.9 | 0.6 ± 1.9 | 0.76 |
Usual carea | 73 | 21.9 ± 4.9 | 5.5 (28.3) | 0.1 | 3.7 ± 3.3 | 0.27 | 23.4 ± 4.7 | 5.0 ± 3.3 | 0.13 |
CCI-all vs. usual careb | − 4.6 ± 3.8 | 0.23 | − 2.1 ± 3.9 | 0.59 | − 4.4 ± 3.8 | 0.24 | |||
∆Diuretics (%) | |||||||||
CCI-all educationa | 218 | 31.7 ± 3.2 | − 9.6 (41.3) | 0.0006 | − 9.5 ± 2.7 | 0.0004 | 31.3 ± 3.1 | − 9.7 ± 2.7 | 0.0004 |
Usual carea | 73 | 30.1 ± 5.4 | 5.5 (32.9) | 0.16 | 5.2 ± 4.8 | 0.28 | 33.0 ± 5.3 | 3.2 ± 4.1 | 0.44 |
CCI-all vs. usual careb | − 15.1 ± 4.8 | 0.001 | − 14.7 ± 5.6 | 0.009 | − 12.8 ± 4.9 | 0.009 |