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

Abstract

The objective of this trial was to assess the long-term effect of the CHANGE lifestyle coaching intervention for 428 people with abdominal obesity and schizophrenia spectrum disorders on cardiovascular risk. In this randomized, superiority, multi-center clinical trial, participants were randomized to 12 months of either lifestyle coaching plus care coordination (N = 138), care coordination alone, (N = 142) or treatment as usual (N = 148). There was no effect after 12 months, but we hypothesized that there might have been a delayed treatment effect. Our primary outcome at two-year follow-up was 10-year risk of cardiovascular disease standardized to 60 years of age.After two-years the mean 10-year cardiovascular-disease risk was 8.7% (95% confidence interval (CI) 7.6–9.9%) in the CHANGE group, 7.7% (95% CI 6.5–8.9%) in the care coordination group, and 8.9% (95% CI 6.9–9.2%) in the treatment as usual group (P = 0.24). Also, there were no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, weight, physical activity, diet and smoking. No reported adverse events could be ascribed to the intervention. We conclude that there was neither any direct nor any long-term effect of individual lifestyle coaching or care coordination on cardiovascular risk factors in people with abdominal obesity and schizophrenia spectrum disorders. The trial was approved by the Ethics Committee of Capitol Region Copenhagen, Denmark (registration number: H-4-2012-051) and the Danish Data Protection Agency (registration number: 01689 RHP-2012-007). The trial was funded by the Mental Health Services of the Capital Region of Denmark, the Lundbeck Foundation, the Tryg Foundation, the Danish Ministry of Health, and the Dæhnfeldts Foundation.

Outcome of a psychosocial health promotion intervention aimed at improving physical health and reducing alcohol use in patients with schizophrenia and psychotic disorders (MINT)

“…For instance, the Danish CHANGE trial evaluated how care coordination alone, lifestyle coaching plus care coordination, or treatment as usual in adults with schizophrenia spectrum disorders and increased waist circumference affected cardiovascular risk (Speyer et al, 2016). Like the present study, the CHANGE intervention had no effect on cardiometabolic risk factors such as cardiorespiratory fitness, physical activity, weight, diet, or smoking (Jakobsen et al, 2017;Speyer et al, 2016). This is not entirely surprising given that most health promotion and weight loss interventions targeting the general population have modest effects, and people with schizophrenia and psychotic disorders have additional obstacles to overcome.…”

What is the risk‐benefit ratio of long‐term antipsychotic treatment in people with schizophrenia?

“…Some of these advantages persisted over time. Unfortunately, challenges in engagement limit the effectiveness of these interventions.…”

Implementation barriers and facilitators of an integrated multidisciplinary lifestyle enhancing treatment for inpatients with severe mental illness: the MULTI study IV

“…Although these studies were vital to show that lifestyle interventions work (i.e. efficacy), the evidence to support the long-term sustainability of lifestyle interventions for patients with SMI is currently limited [18, 21, 23]. The gap between the increase in evidence and policies regarding lifestyle interventions for people with SMI and changes in routine care has been stressed several times, calling for action [24–28].…”