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, Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Denmark.
  • ,
  • Hans Christian Brix Nørgaard
  • Merete Birk
  • Mette Karlsen, University of Copenhagen
  • ,
  • Ane Storch Jakobsen, Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Denmark.
  • ,
  • Kamilla Pedersen
  • Carsten Hjorthøj, University of Copenhagen
  • ,
  • Charlotta Pisinger, Institute of Preventive Medicine, Bispebjerg and Frederiksberg Hospitals, the Capital Region, Copenhagen, Denmark (SCL, LÄ, BLH, and TIAS); the Novo Nordisk Foundation Center for Basic Metabolic Research, Section on Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark (TSA, OP, TH, and TIAS); the Research Centre for Prevention and Health, Glostrup University Hospital, Glostrup, Denmark (TS, AL, LLNH, UT, and BLH); the Danish Cancer Society Research Center, Copenhagen, Denmark (NR, AT, and JH); the Section of Epidemiology, Department of Public Health, Aarhus University, Aarhus, Denmark (KO); the Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark (KO); the National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark (BLH); and the Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, The University of Sydney, Sydney, Australia (BLH).
  • ,
  • Christian Gluud, University of Copenhagen
  • ,
  • Ole Mors
  • Jesper Krogh, University of Copenhagen
  • ,
  • Merete Nordentoft, Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Denmark.

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
Issue2
Pages (from-to)155-65
Number of pages11
ISSN1723-8617
DOIs
Publication statusPublished - Jun 2016

    Research areas

  • Journal Article

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