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Table 3 Clinical characteristics of participants at baseline for all participants and changes over time for each arm separately at baseline, 12 months and 15 months follow-up and estimated pooled treatment effects (95% confidence intervals), p value of test and effect size Cohen’s d for continuous outcomes

From: Randomised control trial of the effectiveness of an integrated psychosocial health promotion intervention aimed at improving health and reducing substance use in established psychosis (IMPaCT)

Variable

Combined

Treatment as Usual (TAU)

IMPACT Therapy (Health Promotion Intervention (HPI))

Mixed model results

 

Baseline

Baseline

12 months

15 months

Baseline

12 months

15 months

 
 

N

Mean(SD)/N(%)

N

Mean(SD)/N(%)

N

Mean(SD)/N(%)

N

Mean(SD)/N(%)

N

Mean(SD)/N(%)

N

Mean(SD)/N(%)

N

Mean(SD)/N(%)

Treatment effect (95% C.I.)

p value

Cohen’s d

SF-36 PCS

406

48.03 (10.54)

193

48.68 (9.58)

132

49.01 (10.33)

114

48.88 (9.62)

213

47.44 (11.32)

127

46.51 (11.24)

117

47.54 (11.14)

−1.40 (−3.20 to 0.41)

0.13

−0.13

SF-36 MCS

406

43.25 (13.02)

193

43.72 (12.22)

132

44.5 (13.47)

114

44.91 (13.42)

213

42.81 (13.73)

127

43.9 (12.97)

117

42.3 (13.42)

−0.13 (−2.49 to 2.24)

0.92

0.01

BMI <100 only

380

31.17 (7.52)

177

31.79 (7.49)

124

32.29 (8.01)

102

33.6(9.61)

203

30.63 (7.52)

120

30.51 (7.38)

103

30.04 (7.67)

−0.45 (−1.32 to 0.42)

0.31

−0.06

Waist (cm)

378

106.81 (17.94)

178

107.39 (16.38)

124

109.25 (16.52)

108

110.96 (16.62)

200

106.29 (19.24)

121

106.05 (16.44)

111

104.22 (16.21)

−1.83 (−3.82 to 0.17)

0.07

−0.1

Smoker

405

253 (62.5%)

193

112 (58)

132

80 (62.1)

113

64 (56.6)

212

141 (66.5)

127

81 (63.8)

116

74 (63.8)

1.05 (0.37 to 3.03)

0.93

N/A

Cigarettes/day (if smoker)

244

18.30 (11.54)

108

18.27 (9,75)

80

18.06 (11.04)

61

17.31 (10.67)

136

18.32 (12.83)

81

19.79 (15.49)

71

18.97 (15.59)

0.1 (−0.33 to 0.53)

0.65

N/A

Cannabis user

405

50 (12.3)

193

26 (13.5)

158

21 (13.3)

148

12 (8.1)

212

24 (11.3)

160

21 (13.1)

153

21 (13.7)

1.40 (0.51 to 3.93)

0.50

N/A

Cocaine use

405

7 (1.7)

193

3 (1.5)

158

2 (1.3)

148

1 (0.7)

212

4 (1.9)

160

0 (0)

153

1 (0.9)

–

–

–

HBA1c (%)

303

40.49 (8.17)

148

40.93 (8.34)

91

41.77 (9.16)

85

40.79 (10.69)

155

40.06 (8)

80

38.6 (9.2)

86

39.28 (10.48)

−0.32 (−1.49 to 0.86)

0.59

−0.04

Cholesterol

289

5.16 (1.46)

136

5.07 (1.11)

86

4.86 (1.12)

80

4.70 (1.32)

153

5.23 (1.72)

80

4.96 (1.02)

85

4.81 (1.00)

0.01 (−0.28 to 0.30)

0.93

0.01

HDL cholesterol

306

1.25 (0.43)

137

1.28 (0.35)

86

1.25 (0.34)

80

1.19 (0.34)

153

1.23 (0.5)

80

1.30 (0.30)

85

1.30 (0.35)

0.085 (0.007 to 0.16)

0.034

0.20

LDL cholesterol

290

3.06 (1.01)

137

3.03 (1)

86

2.77 (1.07)

80

2.73 (1.11)

153

3.08 (1.01)

80

2.9 (0.96)

85

2.75 (0.95)

0.06 (−0.11 to 0.24)

0.49

0.06

Triglycerides

307

2.08 (1.7)

150

2.12 (1.67)

91

2.23 (1.97)

86

2.03 (1.38)

157

2.04 (1.74)

82

1.82 (1.4)

90

2.09 (2.47)

0.01 (−0.37 to 0.4)

0.95

0.01

C-Reactive Protein (CRP)

238

5.65 (7.91)

124

5.46 (7.02)

24

6.59 (6.35)

17

4.98 (5.49)

114

5.85 (8.81)

20

4.55 (3.79)

11

4.2 (4.78)

0.76 (−1.25 to 2.77)

0.46

0.1

Hypertension

380

246 (64.7%)

178

110 (61.8%)

125

82 (65.6%)

106

67 (63.2%)

202

136 (67.3%)

120

76 (63.3%)

112

68 (60.7%)

0.71 (0.38 to 1.36)

0.31

N/A

DINE saturated fat score

393

31.69 (12.74)

186

31.88 (12.54)

125

32.47 (14.33)

110

31.76 (14.13)

207

31.52 (12.95)

123

31.83 (13.23)

110

31.19 (12.61)

−0.19 (−2.82 to 2.44)

0.89

−0.01

Audit

270

5.8 (6.09)

127

5.4 (5.77)

79

5.05 (5.54)

68

4.76 (4.83)

143

6.15 (6.35)

84

6.98 (6.46)

77

7.43 (6.69)

0.19 (−0.02 to 0.39)

0.07

0.19

IPAQ

99

3197.74 (3701.23)

47

3472.78 (3841.4)

36

2543.28 (3554.38)

28

2011.84 (2738.3)

52

2949.14 (3589.07)

32

1540.72 (1563.33)

23

2695.74 (2764.05)

−0.08 (−0.4 to 0.25)

0.65

−0.02

MADRS

403

10.99 (9.46)

193

11.05 (9.33)

132

10.23 (8.97)

114

9.92 (8.8)

210

10.93 (9.59)

127

10.87 (9.56)

115

12.03 (9.99)

0.49 (−1.23 to 2.22)

0.58

0.05

GAF

402

59.33 (13.19)

193

60.88 (13.38)

130

55.56 (12.64)

114

53.59 (11.01)

209

57.9 (12.87)

126

53.01 (11.03)

117

52.63 (11.42)

−0.7 (−3.44 to 2.03)

0.62

−0.05

PANSS (total)

399

51.38 (14.14)

191

51.63 (14.46)

131

50.08 (12.74)

114

49.4 (14.8)

208

51.14 (13.86)

127

51.24 (13.44)

115

50.8 (13.77)

1.37 (−1.23 to 3.96)

0.3

0.1

  1. Presented descriptive statistics are mean (SD) for continuous variables and N (%) for categorical data. Statistics for changes over time within treatment arm and treatment effects are based on patients with follow-up data collected within defined time window
  2. Hypertension, smoking and cannabis use were binary variables (yes or no) and a logistic model was used. Treatment effects are odds ratios. Number of cocaine users was too small to fit a logistic model
  3. Number of cigarettes was modelled using a Poisson distribution. Treatment effects are incidence rate ratios. Only models with random intercept for care coordinators and id could be fitted for logistic and Poisson models. A model for saturated fat categories could not be estimated