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

BackgroundLife 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/designThe 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.DiscussionThe 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 registrationClinical Trials.gov NCT01585493. Date of registration 27th of March 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-015-0465-2) contains supplementary material, which is available to authorized users.

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

“…Patients were recruited from well‐defined catchment areas in two major Danish cities (Aarhus and Copenhagen). The trial protocol was published in 2015 with no changes made to the original version.…”

“…These methods were incorporated into four manuals with detailed descriptions of the interventions addressing four tracks: care coordination, smoking cessation, healthy diet, and physical activity. Manuals are provided in the paper describing the trial protocol.…”

Effect of lifestyle coaching versus care coordination versus treatment as usual in people with severe mental illness and overweight: Two-years follow-up of the randomized CHANGE trial

“…The hypothesis was that a 12-months individually tailored lifestyle coaching intervention would reduce the estimated 10-year cardiovascular-disease risk of, and that the effects would be sustainable with positive results remaining at two-years follow-up. The trial design and the one-year results are described elsewhere[ 8 ], [ 9 ], and showed no effect of the intervention compared with treatment as usual on any outcomes. Based on our theoretical framework Motivational Interviewing and Stages of Change, participants might theoretically have moved from lower towards higher levels of motivation to change health behaviour, resulting in post-intervention weight loss, smoking cessation, improved cardiorespiratory fitness etc.…”

Saliva as a Blood Alternative for Genome-Wide DNA Methylation Profiling by Methylated DNA Immunoprecipitation (MeDIP) Sequencing

“…As part of the CHANGE project [87], peripheral blood (10 mL) and saliva (2 mL) samples were collected in EDTA tubes (BD, Franklin Lakes, NJ, USA) and Oragene saliva collection tubes for DNA extraction (OG-500, DNA Genotek, Ottawa, ON, Canada), respectively, from adult individuals. Blood samples were stored <6 months at −20 • C and saliva samples 6-12 months at ambient temperatures before extraction.…”