Table 4.
Mean change in a range of variables from baseline to 12 weeks and baseline to 24 weeks within each treatment group and the least squares mean (LSM) difference in change between treatment groups (ITT population BOCF approach).
| Characteristic and follow-up time | Treatment group Mean change (SD) |
Absolute difference between groups LSM (95% CI) |
P values for group effect | |||
|
|
Basic | Enhanced | Enhanced vs basic | Difference at follow-up | Difference between groups | |
| Weight (kg) |
|
|
|
|
|
|
|
|
12 weeks | –2.7 (4.0) | –3.3 (4.5) | 0.6 (–0.3, 1.6) | .21 | .13 |
|
|
24 weeks | –3.0 (4.5) | –3.9 (6.2) | 1.0 (–0.2, 2.2) | .11 | |
| Percentage weight loss (%) |
|
|
|
|
|
|
|
|
12 weeks | –2.90 (4.09) | –3.61 (4.69) | 0.71 (–0.30, 1.71) | .17 | .12 |
|
|
24 weeks | –3.17 (4.74) | –4.19 (6.34) | 1.02 (–0.27, 2.30) | .12 | |
| Attained 5% weight loss (%) |
|
|
|
|
|
|
|
|
12 weeks | 24.5 (43.1) | 32.9 (47.1) | 8.43 (–1.87, 18.73) | .11 | .09 |
|
|
24 weeks | 28.7 (45.4) | 36.7 (48.4) | 8.07 (–2.58, 18.73) | .13 | |
| Systolic blood pressure (mmHg) |
|
|
|
|
|
|
|
|
12 weeks | –3.40 (10.31) | –3.94 (9.66) | 0.52 (–1.60, 2.65) | .63 | .92 |
|
|
24 weeks | –2.46 (9.71) | –2.14 (10.85) | 0.35 (–1.77, 2.47) | .75 | |
| Diastolic blood pressure (mmHg) |
|
|
|
|
|
|
|
|
12 weeks | –1.82 (8.50) | –2.30 (7.57) | 0.54 (–1.14, 2.22) | .53 | .68 |
|
|
24 weeks | –0.89 (8.59) | –0.91 (7.60) | 0.08 (–1.62, 1.78) | .93 | |
| Body mass index (kg/m2) |
|
|
|
|
|
|
|
|
12 weeks | –0.93 (1.31) | –1.11 (1.52) | 0.18 (–0.14, 0.50) | .28 | .20 |
|
|
24 weeks | –0.97 (1.45) | –1.24 (2.00) | 0.28 (–0.12, 0.68) | .17 | |
| Resting heart rate (bpm) |
|
|
|
|
|
|
|
|
12 weeks | –1.33 (7.12) | –2.35 (6.49) | 1.20 (–0.23, 2.64) | .10 | .03 |
|
|
24 weeks | –1.30 (7.15) | –2.78 (6.86) | 1.64 (0.12, 3.15) | .03 | |
| Waist circumference at umbilicus (cm) |
|
|
|
|
|
|
|
|
12 weeks | –3.37 (4.52) | –3.57 (5.31) | 0.20 (–0.93, 1.33) | .73 | .26 |
|
|
24 weeks | –3.81 (5.17) | –4.93 (6.73) | 1.12 (–0.25, 2.48) | .11 | |
| Waist circumference at narrowest point (cm) |
|
|
|
|
|
|
|
|
12 weeks | –2.48 (4.27) | –3.37 (4.80) | 0.90 (–0.13, 1.92) | .09 | .06 |
|
|
24 weeks | –2.73 (4.26) | –3.79 (6.19) | 1.08 (–0.13, 2.29) | .08 | |
| Waist-to-height ratio at umbilicus |
|
|
|
|
|
|
|
|
12 weeks | –0.02 (0.03) | –0.02 (0.03) | 0.00 (–0.01, 0.01) | .86 | .35 |
|
|
24 weeks | –0.02 (0.03) | –0.03 (0.04) | 0.01 (–0.00, 0.01) | .15 | |
| Waist-to-height ratio at narrowest point |
|
|
|
|
|
|
|
|
12 weeks | –0.01 (0.02) | –0.02 (0.03) | 0.00 (–0.00, 0.01) | .11 | .09 |
|
|
24 weeks | –0.02 (0.02) | –0.02 (0.04) | 0.01 (–0.00, 0.01) | .12 | |
| Total serum cholesterol (mmol/L) |
|
|
|
|
|
|
|
|
12 weeks | –0.08 (0.50) | –0.19 (0.58) | 0.12 (–0.00, 0.24) | .06 | .06 |
|
|
24 weeks | 0.01 (0.44) | –0.06 (0.58) | 0.08 (–0.04, 0.19) | .20 | |
| LDL cholesterol (mmol/L) |
|
|
|
|
|
|
|
|
12 weeks | –0.00 (0.45) | –0.07 (0.46) | 0.09 (–0.02, 0.19) | .11 | .10 |
|
|
24 weeks | 0.02 (0.39) | –0.02 (0.46) | 0.06 (–0.04, 0.16) | .27 | |
| HDL cholesterol (mmol/L) |
|
|
|
|
|
|
|
|
12 weeks | –0.00 (0.14) | –0.01 (0.16) | 0.00 (–0.03, 0.04) | .93 | .86 |
|
|
24 weeks | 0.02 (0.10) | 0.02 (0.16) | 0.01 (–0.02, 0.04) | .68 | |
| Triglycerides (mmol/L) |
|
|
|
|
|
|
|
|
12 weeks | –0.16 (0.63) | –0.26 (0.66) | 0.05 (–0.08, 0.18) | .48 | .27 |
|
|
24 weeks | –0.08 (0.43) | –0.21 (0.65) | 0.08 (–0.04, 0.19) | .18 | |
| LDL to HDL ratio |
|
|
|
|
|
|
|
|
12 weeks | 0.00 (0.40) | –0.04 (0.35) | 0.06 (–0.03, 0.15) | .21 | .23 |
|
|
24 weeks | –0.02 (0.34) | –0.04 (0.36) | 0.03 (–0.06, 0.11) | .51 | |
| Glucose (mmol/L) |
|
|
|
|
|
|
|
|
12 weeks | –0.22 (0.55) | –0.22 (0.55) | 0.02 (–0.10, 0.14) | .78 | .22 |
|
|
24 weeks | –0.02 (0.38) | –0.10 (0.50) | 0.10 (0.00, 0.20) | .05 | |
| Insulin (mIU/L) |
|
|
|
|
|
|
|
|
12 weeks | –1.76 (10.91) | –1.80 (5.47) | 0.29 (–1.25, 1.82) | .71 | .82 |
|
|
24 weeks | –2.37 (9.85) | –2.16 (5.92) | 0.02 (–1.43, 1.47) | .98 | |
| Physical functioning (SF36) |
|
|
|
|
|
|
|
|
12 weeks | 2.48 (20.05) | 4.71 (15.74) | 1.14 (–2.34, 4.62) | .52 | .90 |
|
|
24 weeks | 3.48 (10.40) | 3.38 (13.63) | 0.81 (–1.58, 3.21) | .50 | |
| Mental health (SF36) |
|
|
|
|
|
|
|
|
12 weeks | 2.13 (15.06) | 4.04 (13.43) | 1.58 (–1.41, 4.57) | .30 | .22 |
|
|
24 weeks | 0.82 (11.74) | 3.15 (23.39) | 2.03 (–2.11, 6.17) | .34 | |
| Total physical activity MET (min/week) |
|
|
|
|
|
|
|
|
12 weeks | 215.29 (2448.3) | 373.56 (2467.1) | 96.19 (–424.3, 616.66) | .72 | .20 |
|
|
24 weeks | 136.47 (2303.8) | 653.82 (2882.0) | 474.17 (–112.4, 1060.7) | .11 | |
| Average step count per day |
|
|
|
|
|
|
|
|
12 weeks | 319.92 (2481.3) | 1059.8 (3094.2) | 675.22 (–11.32, 1361.8) | .05 | .05 |
|
|
24 weeks | 36.69 (1838.9) | 485.19 (2766.5) | 405.53 (–191.5, 1002.6) | .18 | |
| Cognitive restraint scale |
|
|
|
|
|
|
|
|
12 weeks | 1.32 (2.72) | 1.74 (3.28) | 0.48 (–0.15, 1.11) | .14 | .12 |
|
|
24 weeks | 1.32 (2.75) | 1.71 (3.10) | 0.43 (–0.22, 1.08) | .19 | |
| Uncontrolled eating scale |
|
|
|
|
|
|
|
|
12 weeks | –1.71 (3.44) | –1.78 (3.41) | 0.14 (–0.58, 0.86) | .70 | .73 |
|
|
24 weeks | –1.55 (3.37) | –1.56 (3.48) | 0.09 (–0.65, 0.82) | .82 | |
| Emotional eating score |
|
|
|
|
|
|
|
|
12 weeks | –0.37 (1.38) | –0.48 (1.56) | 0.10 (–0.22, 0.41) | .54 | .38 |
|
|
24 weeks | –0.40 (1.59) | –0.57 (1.68) | 0.17 (–0.19, 0.52) | .36 | |
| Total energy intake |
|
|
|
|
|
|
|
|
12 weeks | –985.5 (2386.7) | –1248 (2458.1) | 267.74 (–186.4, 721.90) | .25 | .54 |
|
|
24 weeks | –787.1 (2095.4) | –761.4 (2046.2) | 22.36 (–407.4, 452.10) | .92 | |