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.

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.

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.

The authors have not supplied their declaration of competing interest.