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.

Ane Storch Jakobsen, Helene Speyer, Hans Christian Brix Nørgaard, Mette Karlsen, Merete Birk, Carsten Hjorthøj, Ole Mors, Jesper Krogh, Christian Gluud, Charlotta Pisinger, Merete Nordentoft

Journal: PloS one 2017;12(10):e0185881

PMID: 28985228

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The authors assessed the long-term effects of lifestyle coaching for individuals with abdominal obesity and schizophrenia spectrum disorders on cardiovascular risk. Subjects were randomized into 3 groups: 12 months of lifestyle coaching and care coordination, care coordination only or treatment as usual (control). Lifestyle coaching consisted of support from a CHANGE coach who had experience in psychiatry and special training in stopping smoking, healthy diets, and monitoring and treatment of lifestyle diseases. There was at least one face to face meeting per week, plus phone calls, text and email messages. Care co-ordination consisted of support by a specially trained psychiatric nurse, with focus on the symptoms of cardiovascular disease, diabetes or obstructive pulmonary disease. Meetings, telephone calls and messages were adjusted based on personal need. The results did not show any significant effects between the groups at 12 months. After 2 years, 25.4% in the CHANGE group, 19.7% in the care coordination group, and 16.9% in the treatment as usual group had lost at least 5% of their baseline weight. There were no statistically significant differences between the groups for cardiorespiratory fitness, BMI, blood lipids and hbA1c, lung function, smoking status, psychotic symptoms or quality of life. It was noted that self-reporting was a limitation to the study, and may have led to errors in reporting, particularly with reference to diet. In addition, only 42.8% of the CHANGE coaching group attended at least 50% of the planned sessions, and the authors note that this made it likely that there would have been no benefit to increasing or decreasing the number of sessions. The authors concluded that coaching did not improve the motivation of participants to change their lifestyle choices in either the short or long term, and therefore may not be the right approach for those with schizophrenia.

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.

Address: Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.; Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.; Psychosis Research Unit, Aarhus University Hospital, Risskov, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.; Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.; Psychosis Research Unit, Aarhus University Hospital, Risskov, Denmark.; The Lundbeck Foundation Initiative for Integrative Psychiatric Research, iPSYCH, Aarhus, Denmark.; Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.; Research Centre for Prevention and Health, Capitol Region, Copenhagen, Denmark.

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