The CHANGE trial: no superiority of lifestyle coaching plus care coordination plus treatment as usual compared to treatment as usual alone in reducing risk of cardiovascular disease in adults with schizophrenia spectrum disorders and abdominal obesity

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Helene Speyer, Hans Christian Brix Norgaard, Merete Birk, Mette Karlsen, Ane Storch Jakobsen, Kamilla Pedersen, Carsten Hjorthoj, Charlotta Pisinger, Christian Gluud, Ole Mors, Jesper Krogh, Merete Nordentoft

Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel-group, superiority, multi-centre trial with blinded outcome assessment, testing the efficacy of an intervention aimed to improve cardiovascular risk profile and hereby potentially reduce mortality. A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and centrally randomized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual (N=138), or care coordination plus treatment as usual (N=142), or treatment as usual alone (N=148). The primary outcome was 10-year risk of cardiovascular disease assessed post-treatment and standardized to age 60. At follow-up, the mean 10-year risk of cardiovascular disease was 8.4 ± 6.7% in the group receiving lifestyle coaching, 8.5 ± 7.5% in the care coordination group, and 8.0 ± 6.5% in the treatment as usual group (p=0.41). We found no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal obesity.
Original languageEnglish
JournalWorld Psychiatry
Volume15
Issue number2
Pages (from-to)155-165
ISSN1723-8617
DOIs
Publication statusPublished - Jun 2016

    Research areas

  • Schizophrenia, abdominal obesity, CHANGE trial, lifestyle coaching, care coordination, cardiovascular risk, cardiorespiratory fitness, physical activity

ID: 173981413