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Table 2 Changes in quality of life in the LEVA in Real Life trial with missing values imputed using multiple imputationa

From: Cost-effectiveness and quality of life of a diet intervention postpartum: 2-year results from a randomized controlled trial

 

Diet group

Control group

Difference diet vs control groupb

P-value

Effect sizec

SF-6D

 Baseline

0.676

0.660

   

 Change after 12 wk.

0.043 (0.106)

0.029 (0.098)

0.015 (− 0.256; 0.055)

0.47

0.14

 Change after 1 y

0.072 (0.098)

0.054 (0.098)

0.018 (− 0.023; 0.059)

0.38

0.18

 Change after 2 y

0.028 (0.117)

0.024 (0.101)

0.005 (−0.040; 0.049)

0.84

0.04

EQ-5D-3 L

 Baseline

0.832

0.838

   

 Change after 12 wk

0.041 (0.105)

−0.035 (0.213)

0.075 (0.009; 0.142)

0.03

0.45

 Change after 1 y

0.042 (0.141)

0.004 (0.150)

0.038 (−0.023; 0.099)

0.21

0.26

 Change after 2 y

−0.016 (0.221)

−0.015 (0.171)

− 0.001 (− 0.082; 0.080)

0.98

0.01

EQ-VAS

 Baseline

65.6

70.3

   

 Change after 12 wk

10.9 (16.4)

0.2 (18.1)

10.7 (3.9; 17.5)

0.002

0.62

 Change after 1 y

12.1 (14.8)

4.9 (16.5)

7.1 (0.6; 13.7)

0.03

0.46

 Change after 2 y

6.5 (19.6)

2.0 (15.3)

4.5 (−3.0; 12.1)

0.23

0.26

SF-36 Physical functioning

 Baseline

87.5

87.6

   

 Change after 12 wk

2.4 (15.6)

2.2 (11.6)

0.2 (−5.2; 5.5)

0.94

0.01

 Change after 1 y

6.2 (11.0)

4.1 (10.8)

2.1 (−2.4; 6.6)

0.35

0.19

 Change after 2 y

3.9 (14.2)

1.4 (13.2)

2.5 (−3.1; 8.0)

0.38

0.18

Limitations in physical role functioning

 Baseline

67.6

61.6

   

 Change after 12 wk

10.1 (37.9)

20.3 (39.3)

−10.2 (−25.0; 4.6)

0.17

−0.26

 Change after 1 y

18.4 (40.1)

17.9 (43.1)

0.5 (−16.1; 17.0)

0.95

0.01

 Change after 2 y

14.2 (40.4)

11.4 (46.3)

2.8 (−14.9; 20.5)

0.76

0.06

Bodily pain

 Baseline

71.4

67.9

   

 Change after 12 wk

1.2 (24.8)

4.8 (24.0)

−3.6 (−13.0; 5.9)

0.46

−0.15

 Change after 1 y

9.4 (26.8)

12.0 (27.5)

−2.5 (−13.4; 8.3)

0.64

−0.10

 Change after 2 y

7.1 (25.9)

8.9 (26.4)

−1.8 (− 12.2; 8.6)

0.73

−0.07

General health

 Baseline

70.0

75.8

   

 Change after 12 wk

7.9 (15.6)

−2.9 (15.9)

10.8 (4.5; 17.1)

< 0.001

0.69

 Change after 1 y

10.4 (16.1)

−0.5 (18.6)

11.0 (3.6; 18.3)

0.004

0.63

 Change after 2 y

6.0 (16.3)

−2.9 (18.5)

8.9 (1.4; 16.4)

0.02

0.51

Vitality

 Baseline

51.3

52.6

   

 Change after 12 wk

10.1 (19.2)

1.2 (19.0)

9.0 (1.4; 16.5)

0.02

0.47

 Change after 1 y

10.7 (24.9)

6.9 (21.3)

3.8 (−5.8; 13.5)

0.43

0.16

 Change after 2 y

3.7 (22.7)

−2.0 (23.9)

5.7 (−4.0; 15.3)

0.25

0.24

Social functioning

 Baseline

80.3

81.3

   

 Change after 12 wk

7.8 (24.9)

5.5 (16.1)

2.2 (−5.9; 10.3)

0.58

0.11

 Change after 1 y

9.3 (23.8)

4.5 (19.9)

4.9 (−3.8; 13.6)

0.27

0.22

 Change after 2 y

3.6 (28.2)

−0.4 (19.6)

4.0 (−5.7; 13.7)

0.41

0.16

Limitations in emotional role functioning

 Baseline

77.8

78.6

   

 Change after 12 wk

7.0 (39.4)

−0.6 (39.0)

7.7 (−7.4; 22.7)

0.32

0.19

 Change after 1 y

9.9 (40.2)

−2.7 (46.7)

12.6 (−4.6; 29.8)

0.15

0.29

 Change after 2 y

−7.8 (47.0)

−15.0 (45.6)

7.2 (−11.4; 25.9)

0.44

0.16

Mental health

 Baseline

77.3

78.9

   

 Change after 12 wk

4.8 (12.5)

−2.9 (13.4)

7.8 (2.6; 12.9)

0.004

0.59

 Change after 1 y

4.4 (13.3)

−3.1 (14.0)

7.5 (1.5; 13.5)

0.02

0.55

 Change after 2 y

−2.3 (17.9)

−5.9 (15.8)

3.6 (−3.4; 10.6)

0.31

0.21

Physical component summary score

 Baseline

47.5

46.8

   

 Change after 12 wk

2.2 (7.9)

3.7 (7.3)

−1.5 (−4.5; 1.5)

0.32

−0.20

 Change after 1 y

5.1 (8.8)

5.4 (9.2)

−0.3 (−4.0; 3.4)

0.87

−0.03

 Change after 2 y

5.1 (9.8)

4.1 (9.8)

1.0 (−3.1; 5.1)

0.63

0.10

Mental component summary score

 Baseline

45.6

46.7

   

 Change after 12 wk

3.7 (10.2)

−1.3 (9.0)

5.0 (1.3; 8.8)

0.009

0.52

 Change after 1 y

3.3 (11.0)

−1.7 (11.8)

5.0 (0.4; 9.6)

0.03

0.44

 Change after 2 y

−1.8 (13.6)

−5.3 (12.9)

3.5 (−2.2; 9.1)

0.22

0.26

  1. Abbreviations: SF-6D 6-dimensional short-form 6D, EQ-5D-3 L The EuroQol 5D, EQ-VAS The EuroQol visual analog scale, and SF-36 36-item short form health survey. Values are mean (SD) if not indicated differently. aThe multiple imputation procedure used linear regression analysis and the multivariate imputation by chained equations method, and generated 20 complete data sets. The model included variables that were related to the outcome, and/or related to drop out, including study group, age, parity, BMI, gestational weight gain, and QOL at all study visits. Numbers of women at baseline, 12 wk., 1 y and 2 y were 110, 100 (47 and 53 women in the diet and control groups, respectively), 89 (44 and 45, respectively) and 87 at 2 y (41 and 46, respectively) after exclusion of women pregnant > 12 week at a follow-up visit. Drop-outs are presented in Fig. 1 and missing data were limited and missing at random. b Mean (95% CI). c Effect size calculated according to Cohen [31] where a change of 0.2–0.5 is considered small, 0.5–0.8 is considered moderate and > 0.8 is considered large