CHANGE A Randomized Clinical Trial Investigating the Effect of a Lifestyle Coaching Intervention On Cardiovascular Risk in People with Schizophrenia and Overweight
Poster B104, Friday, October 21, 11:30 am - 1:00 pm, Le Baron
Ane Storch Jakobsen1,2, Helene Speyer1,2, Merete Nordentoft1,2, Hans Christian Nørgaard Brix3; 1Mental Health Center Copenhagen, 2University of Copenhagen, 3Aarhus University Hospital
Life expectancy in patients with schizophrenia is reduced by 15 to 20 years compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. The aim of this trial was to improve the cardiovascular risk profile and thereby potentially reduce mortality.The CHANGE trial is an investigator-initiated, randomised, parallel-group, superiority, multi-centre trial with blinded outcome assessment. Patients aged 18 years or above, diagnosed with schizophrenia spectrum disorders and increased waist circumference according to the WHO’s guidelines (88 cm for women, 102 cm for men), were recruited and centrally randomised 1:1:1 to 12-months of lifestyle coaching plus care coordination versus care coordination versus treatment as usual (TAU). The primary outcome was 10-year risk of cardiovascular disease standardised to age 60. A total of 428 participants were randomly assigned to the CHANGE intervention (n=138); care coordination (n=142); or TAU (n=148). At 12 months, the mean 10 years risk of cardiovascular disease was 8.4% (SD 6.7) in the CHANGE group, 8.5% (SD 7.5) in the care coordination group and 8.0% (SD 6.5) in the TAU group (p=0.41). We found no intervention effects for any secondary or explorative outcomes. This provides evidence that the manual-based CHANGE intervention and the care coordinator intervention do not reduce the 10-years risk of cardiovascular disease compared with TAU after one year. Our study stands out as having the so far largest population and the longest follow-up (2 years), and moreover it is unique in its flexible, assertive approach
Topic Area: Psychosocial Interventions