Table 4 Intention to treat analysis - difference between groups in secondary outcomes at post-intervention, 3 and 6 months follow-ups

 Baseline

8.7 (4.9)

9.3 (6.0)

10.4 (6.1)

 Post-intervention

4.1 (3.1)

5.0 (4.9)

9.9 (6.2)

−5.81 (−8.02 to −3.61)

< 0.0001***

−4.91 (− 7.08 to − 2.74)

< 0.0001***

−0.90 (− 3.06 to 1.26)

0.939

 3 month

3.1 (2.4)

4.7 (4.4)

9.0 (5.7)

− 5.89 (− 7.87 to − 3.92)

< 0.0001***

− 4.33 (− 6.27 to −2.39)

< 0.0001***

−1.57 (− 3.50 to 0.36)

0.154

 6 month

3.0 (2.3)

5.5 (4.2)

9.6 (6.0)

−6.59 (− 8.59 to − 4.59)

< 0.0001***

− 4.07 (− 6.04 to − 2.11)

< 0.0001***

−2.52 (− 4.48 to − 0.56)

0.007**

 Baseline

19.1 (5.7)

17.8 (5.5)

17.8 (5.8)

 Post-intervention

23.7 (6.5)

20.8 (5.7)

17.7 (5.2)

6.0 (3.3 to 8.6)

< 0.0001***

3.1 (0.6 to 5.6)

0.010**

2.8 (0.3 to 5.4)

0.026*

 3 month

24.5 (6.0)

20.6 (5.1)

18.0 (5.4)

6.5 (4.0 to 9.0)

< 0.0001***

2.6 (0.2 to 5.1)

0.031**

3.9 (1.5 to 6.3)

< 0.0001**

 6 month

23.8 (6.7)

20.5 (6.1)

17.8 (5.2)

5.9 83.2 to 8.6)

< 0.0001***

2.6 (0 to 5.3)

0.054

3.3 (0.6 to 5.9)

0.009**

 Baseline

13.0 (12.0)

12.2 (12.9)

13.1 (13.1)

 Post-intervention

8.2 (9.6)

9.8 (11.9)

13.5 (12.8)

−5.34 (− 10.49 to − 0.19)

0.039**

−3.74 (−8.80 to 1.33)

0.230

− 1.61 (−6.65 to 3.44)

1.000

 3 month

6.4 (9.1)

8.9 (11.3)

12.7 (12.5)

−6.27 (− 11.22 to − 1.32)

0.008***

−3.73 (−8.61 to 1.14)

0.197

− 2.53 (−7.39 to 2.32)

0.626

 6 month

6.1 (9.3)

9.0 (11.1)

13.2 (12.5)

−7.07 (− 12.00 to − 2.15)

0.002***

−4.18 (−9.02 to 0.67)

0.116

− 2.90 (− 7.72 to 1.92)

0.444

 Baseline

22.5 (25.3)

22.0 (19.8)

21.8 (20.3)

 Post-intervention

98.4 (58.4)

44.8 (32.9)

30.9 (23.3)

67.59 (47.99 to 87.18)

< 0.0001***

13.91 (−26.15 to −1.67)

0.022**

53.67 (33.04 to 74.30)

< 0.0001***

 3 month

97.0 (59.3)

40.9 (29.1)

30.4 (23.8)

66.59 (46.69 to 86.48)

< 0.0001***

10.47 (−0.95 to 21.90)

0.080**

56.11 (35.73 to 76.50)

< 0.0001***

 6 month

107.1 (73.4)

40.8 (31.3)

23.9 (23.3)

83.18 (59.16 to 107.20)

< 0.0001***

16.84 (5.00 to 28.68)

0.003**

66.34 (41.65 to 91.04)

< 0.0001***

 Baseline

37.5 (7.4)

38.2 (8.3)

36.2 (8.7)

 Post-intervention

46.7 (6.2)

44.3 (6.8)

36.8 (8.3)

9.97 (6.76 to 13.19)

< 0.0001***

7.53 (4.24 to 10.83)

< 0.0001***

2.44 (−0.36 to 5.25)

0.101

 3 month

47.4 (7.1)

44.1 (7.6)

36.5 (7.7)

10.85 (7.60 to 14.10)

< 0.0001***

7.59 (4.29 to 10.89)

< 0.0001***

3.26 (0.10 to 6.42)

0.042**

 6 month

46.9 (7.1)

40.6 (7.2)

38.0 (8.5)

8.92 (5.49 to 12.34)

< 0.0001***

2.67 (−0.73 to 6.07)

0.154

6.25 (3.19 to 9.31)

< 0.0001***

 Baseline

46.6 (9.4)

46.7 (9.4)

45.6 (10.5)

 Post-intervention

52.8 (5.9)

49.8 (8.5)

45.2 (9.1)

7.55 (4.17 to 10.93)

< 0.0001***

4.56 (0.76 to 8.37)

0.014**

2.99 (−0.15 to 6.12)

0.065

 3 month

53.6 (6.2)

49.9 (7.8)

46.4 (9.1)

7.19 (3.77 to 10.61)

< 0.0001***

3.51 (−0.15 to 7.18)

0.064

3.68 (0.65 to 6.70)

0.013**

 6 month

53.0 (6.2)

46.4 (8.5)

46.2 (8.3)

6.72 (3.48 to 9.95)

< 0.0001***

0.15 (−3.48 to 3.79)

0.994

6.56 (3.37 to 9.76)

< 0.0001***

 Baseline

22.3 (5.3)

21.6 (7.3)

21.6 (9.5)

 Post-intervention

14.6 (6.5)

17.5 (8.8)

20.6 (9.7)

−6.06 (−9.71 to −2.41)

< 0.0001**

−3.13 (−7.14 to 0.88)

0.157

−2.93 (−6.23 to 0.37)

0.093

 3 month

11.4 (7.9)

18.3 (9.5)

19.8 (9.6)

−8.40 (−12.29 to −4.52)

< 0.0001***

−1.48 (−5.63 to 2.66)

0.673

− 6.92 (−10.68 to −3.15)

< 0.0001**

 6 month

11.7 (8.9)

19.3 (9.3)

21.0 (9.2)

− 9.27 (−13.24 to − 5.29)

< 0.0001***

− 1.66 (− 5.66 to 2.34)

0.588

− 7.61 (− 11.52 to − 3.70)

< 0.0001***

 Baseline

18.7 (4.4)

18.7 (4.4)

18.6 (5.2)

 Post-intervention

8.5 (5.4)

12.2 (6.6)

18.0 (4.9)

−9.44 (−11.71 to −7.17)

< 0.0001***

−5.81 (−8.30 to −3.31)

< 0.0001**

− 3.63 (−6.21 to − 1.05)

0.003**

 3 month

6.5 (6.2)

13.0 (5.6)

17.8 (5.2)

−11.31 (− 13.81 to − 8.80)

< 0.0001***

−4.84 (− 7.15 to − 2.53)

< 0.0001**

−6.47 (− 9.00 to − 3.93)

< 0.0001***

 6 month

7.3 (6.2)

14.6 (5.6)

18.2 (4.7)

−10.96 (− 13.37 to − 8.54)

< 0.0001***

−3.62 (− 5.85 to − 1.38)

0.001*

− 7.34 (− 9.88 to − 4.80)

< 0.0001***

 Baseline

5.8 (2.4)

5.6 (3.6)

6.0 (5.0)

 Post-intervention

4.2 (2.0)

4.9 (3.4)

6.1 (4.2)

−1.96 (−3.41 to −0.51)

0.005**

− 1.24 (− 2.89 to 0.41)

0.177

−0.72 (− 1.92 to 0.48)

0.333

 3 month

4.0 (2.0)

4.8 (3.1)

6.1 (4.1)

−2.04 (−3.49 to −0.60)

0.003**

− 1.21 (− 2.80 to 0.37)

0.169

− 0.83 (− 1.94 to 0.28)

0.180

 6 month

4.2 (2.3)

4.9 (2.9)

6.1 (4.1)

− 1.89 (− 3.35 to − 0.42)

0.008**

−1.17 (− 2.71 to 0.36)

0.169

−0.71 (− 1.84 to 0.42)

0.294

 Baseline

6.3 (2.5)

6.2 (3.9)

6.6 (4.3)

 Post-intervention

5.1 (2.1)

5.5 (3.4)

6.7 (3.3)

−1.69 (−2.92 to −0.46)

0.004**

−1.22 (− 2.68 to 0.24)

0.121

− 0.47 (− 1.69 to 0.75)

0.627

 3 month

4.7 (2.0)

5.5 (3.1)

6.5 (3.6)

−1.79 (−3.07 to − 0.52)

0.003**

−1.00 (− 2.45 to 0.44)

0.231

− 0.79 (− 1.90 to 0.32)

0.215

 6 month

4.5 (2.2)

5.3 (2.9)

6.6 (3.4)

−2.07 (− 3.33 to − 0.80)

0.001**

−1.22 (− 2.59 to 0.15)

0.091

− 0.85 (− 1.95 to 0.25)

0.166