The Impact of the Change Trial on Physical Health in People With Schizophrenia

Abstract

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. The aim of this trial was to improve the cardiovascular risk profile.

Methods

The CHANGE trial was an investigator-initiated, randomised, parallel-group, superiority, multi-centre trial with blinded outcome assessment. Patients diagnosed with schizophrenia spectrum disorders and increased waist circumference according (>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 alone versus treatment as usual. The primary outcome was 10-year risk of cardiovascular disease assessed post-treatment and standardised to age 60, secondary outcomes included cardiorespiratory fitness and physical activity. Clinical.Trials.gov NCT01585493.

Findings

A total of 428 participants were randomly assigned to the CHANGE intervention (n = 138); care coordination (n = 142); or treatment as usual (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 treatment as usual group (P = 0.41). We found no intervention effects for any secondary or explorative outcomes, including weight, cardiorespiratory fitness, physical activity, diet or smoking.

Interpretation

The CHANGE trial did not support individual lifestyle coaching or care coordination as superior compared with treatment as usual in reducing the cardiovascular risk in patients with schizophrenia and increased waist circumference.

Disclosure of interest

The authors have not supplied their declaration of competing interest.