Article open access publication

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

World Psychiatry, Wiley, ISSN 2051-5545

Volume 15, 2, 2016

DOI:10.1002/wps.20318, Dimensions: pub.1004535092, PMC: PMC4911772, PMID: 27265706,

Affiliations

Organisations

  1. (1) Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.
  2. (2) University of Copenhagen, grid.5254.6, KU
  3. (3) Aarhus University Hospital, grid.154185.c, Central Denmark Region
  4. (4) Aarhus University, grid.7048.b, AU
  5. (5) Rigshospitalet, grid.475435.4, Capital Region
  6. (6) Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Countries

Denmark

Continents

Europe

Description

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.

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Sustainable Development Goals

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NORA University Profiles

University of Copenhagen

Aarhus University

Danish Open Access Indicator

2016: Blocked

Research area: Medicine

Danish Bibliometrics Indicator

2016: Level 2

Research area: Medicine

Dimensions Citation Indicators

Times Cited: 72

Field Citation Ratio (FCR): 27.3

Relative Citation ratio (RCR): 6.9

Open Access Info

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