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
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 t...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Public Library of Science
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5630147/ https://www.ncbi.nlm.nih.gov/pubmed/28985228 http://dx.doi.org/10.1371/journal.pone.0185881 |
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author | Jakobsen, Ane Storch Speyer, Helene Nørgaard, Hans Christian Brix Karlsen, Mette Birk, Merete Hjorthøj, Carsten Mors, Ole Krogh, Jesper Gluud, Christian Pisinger, Charlotta Nordentoft, Merete |
author_facet | Jakobsen, Ane Storch Speyer, Helene Nørgaard, Hans Christian Brix Karlsen, Mette Birk, Merete Hjorthøj, Carsten Mors, Ole Krogh, Jesper Gluud, Christian Pisinger, Charlotta Nordentoft, Merete |
author_sort | Jakobsen, Ane Storch |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5630147 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-56301472017-10-20 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 Jakobsen, Ane Storch Speyer, Helene Nørgaard, Hans Christian Brix Karlsen, Mette Birk, Merete Hjorthøj, Carsten Mors, Ole Krogh, Jesper Gluud, Christian Pisinger, Charlotta Nordentoft, Merete PLoS One Research Article 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. Public Library of Science 2017-10-06 /pmc/articles/PMC5630147/ /pubmed/28985228 http://dx.doi.org/10.1371/journal.pone.0185881 Text en © 2017 Jakobsen et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Jakobsen, Ane Storch Speyer, Helene Nørgaard, Hans Christian Brix Karlsen, Mette Birk, Merete Hjorthøj, Carsten Mors, Ole Krogh, Jesper Gluud, Christian Pisinger, Charlotta Nordentoft, Merete 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5630147/ https://www.ncbi.nlm.nih.gov/pubmed/28985228 http://dx.doi.org/10.1371/journal.pone.0185881 |
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