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.
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.
Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.|Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Denmark.
Helene
H
Speyer
Psychosis Research Unit, Aarhus University Hospital, Risskov, Denmark.|Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Hans
H
Christian Brix Nørgaard
Psychosis Research Unit, Aarhus University Hospital, Risskov, Denmark.
Merete
M
Birk
Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.
Mette
M
Karlsen
Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.|Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Denmark.
Ane
A
Storch Jakobsen
Psychosis Research Unit, Aarhus University Hospital, Risskov, Denmark.|Centre for Health Sciences Education, Aarhus University, Aarhus, Denmark.
Kamilla
K
Pedersen
Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.
Carsten
C
Hjorthøj
Research Centre for Prevention and Health, Department 84-85, Glostrup University Hospital, Glostrup, Denmark.
Charlotta
C
Pisinger
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Christian
C
Gluud
Psychosis Research Unit, Aarhus University Hospital, Risskov, Denmark.
Ole
O
Mors
Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.
Jesper
J
Krogh
Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.|Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Denmark.
Merete
M
Nordentoft
CHANGE trial; Schizophrenia; abdominal obesity; cardiorespiratory fitness; cardiovascular risk; care coordination; lifestyle coaching; physical activity