title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials.gov NCT01585493 . Date of registration 27(th) of March 2012.
authors.affiliation: Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, DK-2400, Copenhagen, Denmark. helene.speyer@regionh.dk.|Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark. helene.speyer@regionh.dk.
authors.forename: Helene
authors.initials: H
authors.lastname: Speyer
authors.affiliation: Research Department P, Aarhus University Hospital, Risskov, Denmark. hansnoer@rm.dk.
authors.forename: Hans Christian Brix
authors.initials: HC
authors.lastname: Nørgaard
authors.affiliation: Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, DK-2400, Copenhagen, Denmark. carsten.rygaard.hjorthoej@regionh.dk.|Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark. carsten.rygaard.hjorthoej@regionh.dk.
authors.forename: Carsten
authors.initials: C
authors.lastname: Hjorthøj
authors.affiliation: Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, DK-2400, Copenhagen, Denmark. thomas.axel.madsen@regionh.dk.
authors.forename: Thomas Axel
authors.initials: TA
authors.lastname: Madsen
authors.affiliation: Research Department P, Aarhus University Hospital, Risskov, Denmark. soerdriv@rm.dk.
authors.forename: Søren
authors.initials: S
authors.lastname: Drivsholm
authors.affiliation: Research Centre for Prevention and Health, Department 84-85, Glostrup University Hospital, Glostrup, Denmark. charlotta.pisinger@regionh.dk.
authors.forename: Charlotta
authors.initials: C
authors.lastname: Pisinger
authors.affiliation: Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. cgluud@ctu.dk.
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.affiliation: Research Department P, Aarhus University Hospital, Risskov, Denmark. nielmors@rm.dk.
authors.forename: Ole
authors.initials: O
authors.lastname: Mors
authors.affiliation: Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, DK-2400, Copenhagen, Denmark. jesper.krogh@regionh.dk.
authors.forename: Jesper
authors.initials: J
authors.lastname: Krogh
authors.affiliation: Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, DK-2400, Copenhagen, Denmark. d198080@dadlnet.dk.|Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark. d198080@dadlnet.dk.
authors.forename: Merete
authors.initials: M
authors.lastname: Nordentoft
mesh_terms: D002318:Cardiovascular Diseases / Q000150:complications* / Q000517:prevention & control*; D002985:Clinical Protocols; D003376:Counseling; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D056128:Obesity, Abdominal / Q000150:complications* / Q000517:prevention & control* / Q000628:therapy; D012559:Schizophrenia / Q000150:complications*