Table 3.
Results for exploratory outcomes
| CHANGE | CARE | TAU | F | p | |
|---|---|---|---|---|---|
| Weight (Kg) | |||||
| Mean±SDa | 103.1 ± 23.8 | 103.7 ± 21.2 | 102.9 ± 21.7 | 1.91 | 0.18 |
| Adjusted mean±SEb | 102.2 ± 0.7 | 103.8 ± 0.7 | 103.6 ± 0.7 | ||
| Body mass index | |||||
| Mean±SDa | 33.9 ± 5.9 | 34.5 ± 6.3 | 34.4 ± 6.3 | 1.88 | 0.19 |
| Adjusted mean±SEb | 33.9 ± 0.2 | 34.4 ± 0.2 | 34.4 ± 0.2 | ||
| Triglycerides (mmol/l) | |||||
| Mean±SDa | 2.0 ± 1.2 | 2.2 ± 1.5 | 2.2 ± 1.5 | 1.25 | 0.34 |
| Adjusted mean±SEb | 2.0 ± 0.1 | 2.1 ± 0.1 | 2.2 ± 0.1 | ||
| Hs‐CRP (mg/l) | |||||
| Mean±SDa | 3.1 ± 2.7 | 3.4 ± 2.8 | 3.1 ± 2.9 | 0.73 | 0.59 |
| Adjusted mean±SEb | 3.2 ± 0.3 | 3.3 ± 0.3 | 3.1 ± 0.3 | ||
| Time spent sedentary (hours/day) | |||||
| Mean±SDa | 9.9 ± 3.6 | 10.5 ± 3.4 | 9.9 ± 3.5 | 1.23 | 0.36 |
| Adjusted mean±SEb | 10.1 ± 0.3 | 10.4 ± 0.3 | 9.9 ± 0.3 | ||
| Daily smoking (yes/no) | 0.65 (CHANGE vs. TAU); 0.79 (CARE vs. TAU) | ||||
| %a | 49.0 | 49.0 | 50.0 | ||
| % (adjusted)b | 49.0 | 49.0 | 50.0 | ||
| Intake of fruit (g/week) | |||||
| Mean±SDa | 393.1 ± 268.5 | 439.8 ± 270.7 | 421.4 ± 258.1 | 1.39 | 0.31 |
| Adjusted mean±SEb | 394.8 ± 20.0 | 428.6 ± 20.3 | 430.5 ± 20.0 | ||
| Intake of vegetables (g/week) | |||||
| Mean±SDa | 507.5 ± 338.8 | 475.7 ± 325.1 | 479.3 ± 307.7 | 1.25 | 0.34 |
| Adjusted mean±SEb | 518.2 ± 28.0 | 477.2 ± 27.3 | 467.9 ± 27.1 | ||
| Intake of fish (g/week) | |||||
| Mean±SDa | 138.1 ± 14.5 | 145.0 ± 13.9 | 140.8 ± 14.4 | 0.35 | 0.73 |
| Adjusted mean±SEb | 136.2 ± 12.3 | 144.9 ± 12.3 | 142.6 ± 12.2 | ||
| Intake of saturated fat (yes/no) | 0.08 (CHANGE vs. TAU); 0.33 (CARE vs. TAU) | ||||
| %a | 52.0 | 62.0 | 66.0 | ||
| % (adjusted)b | 55.0 | 59.0 | 65.0 | ||
| Positive symptoms (SAPS global score) | |||||
| Mean±SDa | 1.7 ± 1.6 | 1.7 ± 1.6 | 1.8 ± 1.6 | 1.44 | 0.29 |
| Adjusted mean±SEb | 1.6 ± 0.1 | 1.6 ± 0.1 | 1.8 ± 0.1 | ||
| Negative symptoms (SANS global score) | |||||
| Mean±SDa | 2.1 ± 1.2 | 2.0 ± 1.2 | 2.0 ± 1.2 | 0.74 | 0.52 |
| Adjusted mean±SEb | 2.1 ± 0.1 | 2.0 ± 0.1 | 2.0 ± 0.1 | ||
| Cognition (BACS composite score) | |||||
| Mean±SDa | 244.3 ± 50.1 | 235.8 ± 50.2 | 242.0 ± 49.5 | 2.54 | 0.12 |
| Adjusted mean±SEb | 238.8 ± 2.2 | 239.0 ± 2.2 | 244.1 ± 2.1 | ||
| Quality of life (MANSA score) | |||||
| Mean±SDa | 4.7 ± 0.8 | 4.7 ± 0.8 | 4.7 ± 0.8 | 0.74 | 0.52 |
| Adjusted mean±SEb | 4.7 ± 0.07 | 4.8 ± 0.07 | 4.7 ± 0.07 | ||
| Quality of life (EuroQOL score) | |||||
| Mean±SDa | 1.4 ± 0.3 | 1.4 ± 0.3 | 1.3 ± 0.3 | 1.14 | 0.36 |
| Adjusted mean±SEb | 1.4 ± 0.03 | 1.4 ± 0.03 | 1.3 ± 0.03 | ||
| GAF total score | |||||
| Mean±SDa | 49.4 ± 11.2 | 47.6 ± 9.8 | 47.8 ± 9.4 | 1.19 | 0.35 |
| Adjusted mean±SEb | 49.0 ± 0.8 | 48.1 ± 0.8 | 47.6 ± 0.8 | ||
| Perceived health | |||||
| Mean±SDa | 2.8 ± 1.0 | 2.8 ± 0.9 | 2.7 ± 0.8 | 0.33 | 0.74 |
| Adjusted mean±SEb | 2.7 ± 0.1 | 2.8 ± 0.1 | 2.7 ± 0.1 | ||
| Perceived stress | |||||
| Mean±SDa | 26.8 ± 7.8 | 27.0 ± 7.4 | 25.5 ± 7.4 | 1.68 | 0.26 |
| Adjusted mean±SEb | 27.1 ± 0.6 | 26.5 ± 0.6 | 25.7 ± 0.6 |
CARE – care coordination, TAU – treatment as usual, Hs‐CRP – high sensitivity C‐reactive protein, SAPS – Scale for the Assessment of Positive Symptoms, SANS – Scale for the Assessment of Negative Symptoms, BACS – Brief Assessment of Cognition in Schizophrenia, MANSA – Manchester Short Assessment of Quality of Life, GAF – Global Assessment of Functioning
a
after multiple imputation
adjusted for gender, research center and baseline risk of cardiovascular disease
For dichotomous outcomes, a mean difference in risk ratios was calculated using the risk ratio in the TAU group as reference