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

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. CHANGE was a randomized, parallel‐group, superiority, multi‐centre trial with blinded outcome assessment, testing the efficacy of an intervention aimed to improve cardiovascular risk profile and hereby potentially reduce mortality. A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and centrally randomized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual (N=138), or care coordination plus treatment as usual (N=142), or treatment as usual alone (N=148). The primary outcome was 10‐year risk of cardiovascular disease assessed post‐treatment and standardized to age 60. At follow‐up, the mean 10‐year risk of cardiovascular disease was 8.4 ± 6.7% in the group receiving lifestyle coaching, 8.5 ± 7.5% in the care coordination group, and 8.0 ± 6.5% in the treatment as usual group (p=0.41). We found no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal obesity.

Is there an association between cardiorespiratory fitness and stage of illness in psychotic disorders? A systematic review and meta‐analysis

“…As shown in Tables and , 38 studies met criteria for inclusion in the qualitative synthesis and all were published after 2005 .…”

“…Sample sizes varied largely in relation to the type of study; for instance, the cohorts included between 2682 and 1.1 million participants and were >80% male . By contrast, the cross‐sectional studies included a total of 2698 cases (across Stages 1–4) and 3129 HC and all except one of these studies comprised 55–100% males. The median sample age was about 33 years, and 13 studies reported the inclusion of affective or schizoaffective alongside non‐affective psychoses .…”

Cardiometabolic Risks in Schizophrenia and Directions for Intervention, 2: Nonpharmacological Interventions

“…In the very recent 3-arm CHANGE trial, one of the largest, longest, and most ambitious RCTs in the field to date, Speyer et al 18 randomized 428 patients with schizophrenia spectrum disorders and abdominal obesity to receive lifestyle training with care coordination and treatment as usual, care coordination with treatment as usual, or only treatment as usual.…”

“…An important strength of this adequately powered study 18 is that it was pragmatic; there were few exclusion criteria, and there were no elements in the treatment program that were mandatory and that might have resulted in the elimination of more severely ill patients. Thus, the trial had good external validity.…”

“…Behavioral interventions for patients with schizophrenia are difficult to implement for reasons related to poor motivation, poor participation, poor compliance, and a need for close supervision, and outcomes may be disappointing, as the CHANGE trial demonstrated. 18 In the CHANGE trial, 18 only 60% of patients attended at least half of the scheduled meetings (which is itself a low threshold for compliance with a treatment program).…”