Cited by 20Schizophrenia research and treatmentCardiac Health and Mental HealthHealth Promotion and Cardiovascular Prevention

Protocol for CHANGE: a randomized clinical trial assessing lifestyle coaching plus care coordination versus care coordination alone versus treatment as usual to reduce risks of cardiovascular disease in adults with schizophrenia and abdominal obesity

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Speyer, Helene, Nørgaard, Hans Christian Brix, Hjorthøj, Carsten, Madsen, Thomas Axel, Drivsholm, Søren, Pisinger, Charlotta, Gluud, Christian, Mors, Ole +2 more·2015·BMC Psychiatry

Abstract

BACKGROUND: Life expectancy in patients with schizophrenia is reduced by 20 years for males and 15 years for females compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being the single largest cause of death. METHODS/DESIGN: The CHANGE trial is an investigator-initiated, independently funded, randomized, parallel-group, superiority, multi-centre trial with blinded outcome assessment. 450 patients aged 18 years or above, diagnosed with schizophrenia spectrum disorders and increased waist circumference, will be recruited and randomized 1:1:1 to 12-months interventions. We will compare the effects of 1) affiliation to the CHANGE team, offering a tailored, manual-based intervention targeting physical inactivity, unhealthy dietary habits, and smoking, and facilitating contact to their general practitioner to secure medical treatment of somatic comorbidity; versus 2) affiliation to a care coordinator who will secure guideline-concordant monitoring and treatment of somatic comorbidity by facilitating contact to their general practitioner; versus 3) treatment as usual to evaluate the potential add-on effects of lifestyle coaching plus care coordination or care coordination alone to treatment as usual. The primary outcome is the 10-year risks of cardiovascular disease assessed at 12 months after randomization. DISCUSSION: The premature mortality observed in this vulnerable population has not formerly been addressed specifically by using composite surrogate outcomes for mortality. The CHANGE trial expands the evidence for interventions aiming to reduce the burden of metabolic disturbances with a view to increase life expectancy. Here, we present the trial design, describe the methodological concepts in detail, and discuss the rationale and challenges of the intermediate outcomes. TRIAL REGISTRATION: Clinical Trials.gov NCT01585493 . Date of registration 27(th) of March 2012.

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Authors
Speyer, H., Nørgaard, H. C. B., Hjorthøj, C., Madsen, T. A., Drivsholm, S., Pisinger, C., Gluud, C., Mors, O., Krogh, J., & Nordentoft, M.
Affiliations
  • University of Copenhagen (DK)
  • Aarhus University Hospital (DK)
  • Mental Health Services (DK)
  • Glostrup Hospital (DK)
  • Copenhagen University Hospital (DK)
Corresponding author
Speyer, Helene
Venue
BMC Psychiatry
Published
2015-05-23
Volume
15
Issue
1
Pages
119-119
ISSN
1471-244X (ISSN-L)
OpenAlex
W1946483406
Cited by
20
References
86
Citations by year
2026: 2 · 2025: 2 · 2023: 1 · 2022: 3 · 2021: 1 · 2019: 1 · 2018: 4 · 2017: 5 · 2016: 1
FWCI
2.70
Type
journal article
Language
en
Open access
Locations
  • BMC Psychiatry (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
Funders
  • Lundbeckfonden (R155-2014-1724, R108-2012-10620)
  • Region Hovedstaden
  • TrygFonden
  • H. Lundbeck A/S
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health Promotion and Cardiovascular Prevention
Keywords
schizophrenia, abdominal obesity, cardiovascular risk, lifestyle coaching, care coordination, somatic comorbidity, physical inactivity, dietary habits, smoking, premature mortality, life expectancy, waist circumference, metabolic disorders, general practitioner contact
MeSH terms
Cardiovascular Diseases, Clinical Protocols, Counseling, Female, Humans, Life Style, Male, Middle Aged, Schizophrenia, Obesity, Abdominal

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