Table 2.
Differences in outcome measures between intervention- and routine care groups in the MILE-study at 6 and 12 months’ follow-up
| 6 months’ follow-up | 12 months’ follow-up | |||||||
|---|---|---|---|---|---|---|---|---|
| n Intervention/Routine care |
Intervention Change from baseline, mean (95% CI) | Routine care Change from baseline, mean (95% CI) | ∆ between groups (95% CI) | n Intervention/Routine care |
Intervention Change from baseline, mean (95% CI) | Routine care Change from baseline, mean (95% CI) | ∆ between groups (95% CI) | |
| PRIMARY OUTCOME | ||||||||
| VO2max (ml/kg/min) | 80/69 | 2.3 (1.5;3.2)* | 1.9 (1.1;2.7)* | − 0.5 (− 1.6;0.7) | 66/47 | 3.8 (2.6;5.0)* | 3.5 (1.7;5.2)* | − 0.3 (− 2.3;1.6) |
| VO2max (l/min) | 80/69 | 0.2 (0.1;0.3)* | 0.1 (0.1;0.2)* | − 0.0 (− 0.1;0.1) | 66/47 | 0.3 (0.2;0.4)* | 0.2 (0.1;0.4)* | − 0.1 (− 0.2;0.1) |
| SECONDARY OUTCOMES | ||||||||
| Weight (kg) | 81/73 | − 0.9 (− 1.6;-0.2) | − 0.7 (− 1.5;0.2) | 0.3 (− 0.8;1.4) | 71/58 | −1.2 (− 2.3;-0.0) | −0.6 (− 2.3;1.2) | 0.6 (− 1.4; 2.6) |
| BMI (kg/m2) | 81/73 | −0.3 (− 0.5;-0.1) | −0.2 (− 0.5;0.1) | 0.1 (− 0.3;0.4) | 71/58 | −0.3 (− 0.7;0.0) | −0.1 (− 0.7;0.4) | 0.2 (− 0.4;0.8) |
| Waist circumference (cm) | N/A | N/A | N/A | 70/56 | −2.7 (−4.3;-1.1)* | − 3.5 (− 5.2;-1.8)* | − 0.8 (− 3.1;1.5) | |
| SF-12 mental score, n (%) | N/A | N/A | N/A | 67/49 | 0.5 (−2.5;3.4) | 0.5 (− 1.9;3.0) | 0.1 (− 3.9;4.0) | |
| Accelerometer measured physical activity, min/day | ||||||||
| Sedentary (0–100 cpma) | 70/61 | 5.5 (− 12.2;23.1) | −6.7 (− 29.4;16.0) | −12.1 (− 40.2;16.0) | 48/35 | 9.7 (− 13.1;32.4) | 6.0 (− 18.4;30.3) | −3.7 (− 37.0; 29.6) |
| Light (101–1951 cpm) | 70/61 | −4.4 (− 16.2;7.3) | −4.8 (− 20.9;11.3) | −0.4 (− 19.8;19.0) | 48/35 | −4.3 (− 21.6;13.0) | −12.3(− 25.6;1.0) | −8.0 (− 30.9;15.0) |
| Moderate to vigorous (> 1951 cpm)b | 70/61 | 1.5 (− 5.8;8.8) | −1.7 (− 6.3;2.9) | −3.2 (− 12.0;5.6) | 48/35 | −3.9 (− 9.0;1.2) | −6.3 (− 11.1;-1.6) | −2.5 (− 9.6;4.6) |
| Self-reported physical activity | ||||||||
| Moderate to vigorous > 30 min (days/week) | 81/74 | −0.8 (−1.2;-0.4) | −0.8 (− 1.3;-0.2) | −0.0 (− 0.7;0.7) | 71/56 | −0.8 (− 1.4;-0.2) | −0.5 (− 1.1;0.1) | 0.3 (− 0.6;1.1) |
| Very vigorous > 20 min (days/week) | 81/74 | −0.1 (− 0.5;0.2) | −0.4 (0.9;0.0) | −0.3 (− 0.8;0.3) | 71/56 | −0.3 (− 0.6;0.1) | −0.4 (− 1.0;0.1) | −0.2 (− 0.8;0.5) |
| LDL (mmol/l) | N/A | N/A | N/A | 63/52 | 0.2 (− 0.0;0.3) | 0.0 (− 0.1;0.2) | − 0.1 (− 0.4;0.1) | |
| HDL (mmol/l) | N/A | N/A | N/A | 70/54 | 0.0 (− 0.0;0.1) | 0.0 (− 0.0;0.1) | −0.0 (− 0.1;0.1) | |
| HbA1c (mmol/mol) | N/A | N/A | N/A | 70/56 | − 0.1 (− 0.5;0.3) | −0.0 (− 0.6;0.5) | 0.1 (− 0.6;0.8) | |
| Triglyceride (mmol/l) | N/A | N/A | N/A | 70/55 | −0.2 (− 0.5;0,2) | −0.2 (− 0.5;0.0) | −0.0 (− 0.5;0.4) | |
*t-test of significance p ≤ 0.05
acounts per minute
bDue to less than two minutes (mean) in vigorous and very vigorous activity at follow-up, these categories were added to the moderate activity category