Table 4.
Clinical outcome differences between study groups from baseline to 3, 6, and 12 months (intention to treat).
| Clinical outcome and montha | Change from baseline, mean (95% CI) | Between-group difference | ||||
|
|
Intervention (n=32) | Control (n=33) | Adjusted mean (95% CI)b | P | ||
| BMI (kg/m2) |
|
|
|
|
||
|
|
3 | –1.16 (–1.60, –0.73) | –0.14 (–0.47, 0.19) | –0.99 (–1.53, –0.46) | <.001 | |
|
|
6 | –1.20 (–1.70, –0.70) | –0.18 (–0.64, 0.27) | –1.02 (–1.69, –0.35) | .003 | |
|
|
12 | –0.78 (–1.26, –0.31) | –0.65 (–1.12, 0.19) | –0.10 (–0.75, 0.55) | .76 | |
| Waist circumference (cm) |
|
|
||||
|
|
3 | –2.73 (–3.98, –1.49) | –0.67 (–1.44, 0.11) | –2.04 (–3.47, –0.61) | .006 | |
|
|
6 | –3.05 (–4.68, –1.41) | –0.83 (–1.95, 0.28) | –2.18 (–4.11, –0.24) | .02 | |
|
|
12 | –2.31 (–3.84, –0.79) | –1.80 (–3.02, –0.58) | –0.42 (–2.29, 1.45) | .66 | |
| Systolic blood pressure (mm Hg) |
|
|||||
|
|
3 | –2.69 (–6.48, 1.10) | –1.64 (–6.02, 2.75) | –0.81 (–5.61, 3.99) | .74 | |
|
|
6 | –1.31 (–4.83, 2.20) | 0.88 (–3.79, 5.55) | –1.92 (–6.48, 2.65) | .40 | |
|
|
12 | –1.22 (–4.33, 1.90) | –2.12 (–2.25, 6.49) | –3.13 (–7.69, 1.43) | .18 | |
| Diastolic blood pressure (mm Hg) |
|
|||||
|
|
3 | –3.03 (–5.14, –0.92) | –2.36 (–5.02, 0.29) | –0.83 (–3.76, 2.10) | .58 | |
|
|
6 | –2.63 (–5.05, –0.20) | –1.73 (–5.26, 1.81) | –1.14 (–4.55, 2.27) | .51 | |
|
|
12 | –1.78 (–3.52, –0.05) | –1.55 (–4.57, 1.48) | –0.38 (–3.52, 2.76) | .81 | |
| Total cholesterol (mmol/L) |
|
|||||
|
|
3 | –0.49 (–0.70, –0.28) | –0.06 (–0.31, 0.19) | –0.48 (–0.79, –0.18) | .003 | |
|
|
6 | –0.30 (–0.53, –0.08) | –0.24 (–0.46, –0.02) | –0.07 (–0.38, 0.24) | .64 | |
|
|
12 | –0.19 (–0.38, –0.01) | –0.13 (–0.36, 0.10) | –0.09 (–0.38, 0.20) | .56 | |
| HDL (mmol/L) |
|
|||||
|
|
3 | –0.02 (–0.08, 0.04) | 0.00 (–0.07, 0.07) | –0.03 (–0.11, 0.06) | .51 | |
|
|
6 | –0.01 (–0.07, 0.06) | –0.03 (–0.10, 0.04) | 0.02 (–0.07, 0.12) | .62 | |
|
|
12 | –0.02 (–0.07, 0.02) | 0.02 (–0.06, 0.10) | –0.04 (–0.13, 0.04) | .32 | |
| Triglycerides (mmol/L) c |
|
|||||
|
|
3 | 0.89 (0.82, 0.96) | 1.03 (0.96, 1.10) | 0.87 (0.80, 0.95) | .003 | |
|
|
6 | 0.96 (0.89, 1.04) | 0.98 (0.91, 1.04) | 0.99 (0.90, 1.09) | .79 | |
|
|
12 | 0.97 (0.91, 1.02) | 0.97 (0.90, 1.05) | 1.00 (0.92, 1.09) | .93 | |
| CRP (mg/L) c |
|
|||||
|
|
3 | 0.93 (0.84, 1.03) | 1.01 (0.87, 1.18) | 0.88 (0.74, 0.96) | .13 | |
|
|
6 | 0.89 (0.83, 0.95) | 1.03 (0.86, 1.24) | 0.83 (0.69, 1.01) | .06 | |
|
|
12 | 0.99 (0.80, 1.23) | 0.99 (0.81, 1.21) | 0.93 (0.71, 1.21) | .58 | |
| Energy intake (Kcal) |
|
|||||
|
|
3 | –487.6 (–640.7, –334.5) | –241.4 (–375.8, –106.9) | –216.3 (–364.0, –68.7) | .005 | |
|
|
6 | –314.8 (–466.2, –163.5) | –243.2 (–393.6, –92.8) | –47.8 (–228.5, 133.0) | .60 | |
|
|
12 | –221.6 (–363.5, –79.8) | –204.2 (–384.5, 23.9) | 7.20 (–191.0, 205.4) | .94 | |
| Physical activity (min/day) c,d |
|
|||||
|
|
3 | 2.85 (1.64, 4.94) | 1.43 (0.92, 2.21) | 1.98 (1.09, 3.60) | .03 | |
|
|
6 | 1.43 (1.00, 2.06) | 1.00 (0.61, 1.64) | 1.43 (0.84, 2.44) | .19 | |
|
|
12 | 1.52 (0.95, 2.43) | 1.18 (0.74, 1.89) | 1.28 (0.72, 2.27) | .40 | |
a BMI: body mass index; HDL: high-density lipoprotein cholesterol; CRP: C-reactive protein.
b Difference between groups analyzed using ANCOVA and adjusted for baseline measurements.
c Data presented as ratio of geometric mean and 95% confidence for log-transformed variables.
d Physical activity calculated as time in minutes spent exercising >3.5 METs daily.