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
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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.
I: PLOS ONE, Bind 12, Nr. 10, e0185881, 06.10.2017, s. 1-13.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Effect of lifestyle coaching versus care coordination versus treatment as usual in people with severe mental illness and overweight
T2 - Two-years follow-up of the randomized CHANGE trial
AU - Jakobsen, Ane Storch
AU - Speyer, Helene
AU - Nørgaard, Hans Christian Brix
AU - Karlsen, Mette
AU - Birk, Merete
AU - Hjorthøj, Carsten
AU - Mors, Ole
AU - Krogh, Jesper
AU - Gluud, Christian
AU - Pisinger, Charlotta
AU - Nordentoft, Merete
PY - 2017/10/6
Y1 - 2017/10/6
N2 - 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.
AB - 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.
KW - Adolescent
KW - Adult
KW - Aged
KW - Body Weight
KW - Cardiovascular Diseases
KW - Diet
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Life Style
KW - Male
KW - Mentoring
KW - Middle Aged
KW - Obesity, Abdominal
KW - Overweight
KW - Risk Factors
KW - Schizophrenia
KW - Schizophrenic Psychology
KW - Treatment Outcome
KW - Young Adult
KW - Journal Article
KW - Multicenter Study
KW - Randomized Controlled Trial
U2 - 10.1371/journal.pone.0185881
DO - 10.1371/journal.pone.0185881
M3 - Journal article
C2 - 28985228
VL - 12
SP - 1
EP - 13
JO - PLoS ONE
JF - PLoS ONE
SN - 1932-6203
IS - 10
M1 - e0185881
ER -
ID: 186084586