Table 3 Estimated mean changes in secondary and exploratory outcome measures from randomization (week 0) and from baseline of the run-in (week −4) to week 24 in the intention-to-treat population

From: Anti-obesity medication for weight loss in early nonresponders to behavioral treatment: a randomized controlled trial

Variables

BT + P (n = 38)

BT + AOM (n = 38)

Mean difference (95% CI)

Group x time Cohen’s d

Group x time P value

Time Cohen’s d

Time P value

Systolic BP (mm Hg)

From randomization (week 0)

−0.7 ± 1.8

6.6 ± 1.9

7.3 ± 2.6 (2.1 to 12.5)

0.65

0.007

–

–

 From baseline (week −4)

−1.2 ± 2.0

4.4 ± 2.0

5.6 ± 2.9 (−0.1 to 11.3)

0.45

0.053

–

–

Diastolic BP (mm Hg)

 From randomization (week 0)

2.1 ± 1.4

4.9 ± 1.4

2.8 ± 2.0 (−1.2 to 6.8)

0.33

0.166

–

–

 From baseline (week −4)

1.6 ± 1.5

4.4 ± 1.5

2.8 ± 2.1 (−1.4 to 7.0)

0.30

0.195

–

–

Heart rate (BPM)

 From randomization (week 0)

0.1 ± 1.5

3.9 ± 1.5

3.8 ± 2.1 (−0.3 to 7.9)

0.43

0.069

–

–

 From baseline (week −4)

−0.3 ± 1.6

2.7 ± 1.6

3.0 ± 2.2 (−1.5 to 7.4)

0.32

0.176

–

–

Total cholesterol (mg dl−1)

 From randomization (week 0)

−0.9 ± 4.5

−1.6 ± 0.5

−0.7 ± 6.3 (−11.5 to 10.1)

0.02

0.920

0.09

0.701

 From baseline (week −4)

0.1 ± 4.1

−8.4 ± 4.0

−8.5 ± 5.6 (−18.0 to 0.9)

0.36

0.121

0.35

0.136

HDL cholesterol (mg dl−1)

 From randomization (week 0)

3.3 ± 1.5

1.5 ± 1.4

−1.8 ± 1.9 (−4.8 to 1.3)

0.21

0.367

0.55

0.020

 From baseline (week −4)

0.6 ± 1.7

−1.2 ± 1.6

−1.9 ± 2.3 (−5.6 to 1.9)

0.21

0.376

0.06

0.786

LDL cholesterol (mg dl−1)

 From randomization (week 0)

−2.2 ± 3.8

0.3 ± 4.6

2.5 ± 6.5 (−6.4 to 11.4)

0.10

0.683

0.08

0.730

 From baseline (week −4)

1.4 ± 3.5

−3.7 ± 4.0

−5.1 ± 5.8 (−12.9 to 2.7)

0.21

0.373

0.11

0.623

Triglycerides (mg dl−1)

 From randomization (week 0)

−9.0 ± 7.5

−16.0 ± 7.2

−7.0 ± 10.2 (−24.8 to 10.8)

0.16

0.484

0.56

0.016

 From baseline (week −4)

−9.4 ± 6.9

−21.3 ± 6.9

−11.9 ± 9.7 (−28.0 to 4.1)

0.30

0.203

0.74

0.002

Fasting glucose (mg dl−1)

 From randomization (week 0)

1.0 ± 1.8

−0.7 ± 1.9

−1.7 ± 2.5 (−6.0 to 2.7)

0.16

0.504

0.03

0.898

 From baseline (week −4)

1.8 ± 1.9

−0.03 ± 2.1

−1.9 ± 2.7 (−6.6 to 2.8)

0.17

0.477

0.15

0.523

Depressed mood (PHQ-9)

 From randomization (week 0)

−0.7 ± 0.5

−0.7 ± 0.5

−0.1 ± 0.8 (−1.5 to 1.4)

0.02

0.924

0.45

0.054

 From baseline (week −4)

−1.0 ± 0.7

−1.6 ± 0.7

−0.6 ± 1.0 (−2.4 to 1.3)

0.14

0.543

0.64

0.006

Impact of weight on QOL

 From randomization (week 0)

7.6 ± 2.2

9.8 ± 2.2

2.2 ± 3.0 (−3.6 to 8.0)

0.17

0.458

1.37

<0.001

 From baseline (week −4)

7.1 ± 2.3

10.2 ± 2.3

3.1 ± 3.2 (−3.0 to 9.2)

0.23

0.319

1.29

<0.001

EI cognitive restraint

 From randomization (week 0)

1.1 ± 0.6

0.7 ± 0.6

−0.5 ± 0.9 (−2.1 to 1.2)

0.13

0.575

0.48

0.039

 From baseline (week −4)

2.5 ± 0.7

4.2 ± 0.7

1.7 ± 1.0 (−0.1 to 3.5)

0.42

0.068

1.62

<0.001

EI disinhibition

 From randomization (week 0)

−0.4 ± 0.5

−0.8 ± 0.5

−0.4 ± 0.7 (−1.6 to 0.4)

0.14

0.557

0.45

0.054

 From baseline (week −4)

−0.5 ± 0.6

−1.3 ± 0.6

−0.8 ± 0.9 (−2.3 to 0.7)

0.23

0.316

0.51

0.030

EI Hunger

 From randomization (week 0)

−0.9 ± 0.5

−1.8 ± 0.5

−1.0 ± 0.7 (−2.2 to 0.3)

0.33

0.157

0.92

<0.001

 From baseline (week −4)

−0.6 ± 0.5

−1.5 ± 0.5

−0.8 ± 0.7 (−2.1 to 0.4)

0.30

0.192

0.72

0.002

Physical activity (min per week)

 From randomization (week 0)

29.9 ± 34.0

91.9 ± 34.9

61.9 ± 47.8 (−25.1 to 149.0)

0.31

0.186

0.58

0.013

 From baseline (week −4)

50.0 ± 35.4

112.2 ± 35.6

62.3 ± 49.3 (−27.1 to 151.6)

0.30

0.199

0.75

0.001

  1. Data are estimated as marginal means (±s.e.) for the intention-to-treat population (n = 76) derived from linear mixed models. For laboratory and questionnaire outcomes, multiple imputation was applied before modeling and results represent pooled means and standard errors. Suggested interpretation for Cohen’s d—d < 0.2, minimal difference; d of 0.2–0.5, small difference; d of 0.5–0.8, medium difference; d ≥ 0.8, large difference.
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