Table 6 Change in secondary outcomes (laboratory variables and weight) from baseline to 12-month follow-up
Intervention attributable difference Mean (95% CI) | p value | Intervention attributable difference (IG-CG) (% (95% CI)) Adjusted for age, sex, centre, dietary habits stage motivation and change in physical activity and smoking cessation | p value | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
Outcome measure | EIRA Intervention (n = 1481) | Usual care (n = 1581) | ||||||||
Baseline | After 12 months | Difference | Baseline | After 12 months | Difference | |||||
Total cholesterol (mg/dL) | 206.6 (3.8) | 203.7 (20.0) | -2.9 (20.8) | 206.5 (4.2) | 205.8 (20.0) | -0.7 (21.2) | -2.2 (-10.4 to 6.1) | 0.603 | -1.2 (-4.6 to -2.3) | 0.515 |
LDL-cholesterol (mg/dL) | 127.3 (4.8) | 123.1 (21.4) | -4.2 (23.0) | 127.2 (4.9) | 125.6 (20.7) | -1.6 (22.2) | -2.6 (-10.8 to 5.6) | 0.531 | -1.7 (-5.7 to 2.3) | 0.395 |
HDL-cholesterol (mg/dL) | 53.0 (1.1) | 54.0 (5.4) | 1.0 (5.7) | 53.7 (1.4) | 54.6 (5.3) | 0.9 (5.5) | 0.0 (-2.8 to 2.8) | 0.990 | 0.1 (-1.1 to 1.3) | 0.905 |
Triglycerides (mg/dL) | 148.2 (17.2) | 187.7 (49.3) | 39.5 (49.4) | 146.5 (19.4) | 178.9 (47.2) | 32.4 (48.5) | 7.1 (-17.2 to 31.4) | 0.563 | 5.7 (-7.0 to 18.3) | 0.380 |
Glycated haemoglobin (%) | 7.5 (0.4) | 7.4 (0.8) | -0.1 (0.8) | 7.5 (0.4) | 7.4 (0.8) | -0.0 (0.8) | -0.1 (-0.6 to 0.4) | 0.771 | -0.1 (-0.4 to 0.3) | 0.676 |
Systolic blood pressure (mmHg) | 133.5 (1.4) | 131.6 (6.9) | -1.9 (7.3) | 131.9 (0.7) | 132.1 (5.7) | 0.2 (5.8) | -2.1 (-6.0 to 1.8) | 0.286 | -2.4 (-4.3 to -0.5) | 0.014 |
Diastolic blood pressure (mmHg) | 82.5 (0.7) | 81.9 (3.9) | -0.6 (3.9) | 80.5 (0.4) | 80.9 (3.1) | 0.4 (3.1) | -1.0 (-3.3 to 1.4) | 0.414 | -1.2 (-2.6 to 0.1) | 0.073 |
Weight (kg) | 82.3 (0.6) | 82.1 (5.9) | -0.2 (6.0) | 78.8 (0.4) | 79.1 (4.8) | 0.3 (4.8) | -0.5 (-4.0 to 2.9) | 0.764 | -0.4 (-2.5 to 1.7) | 0.711 |