Trial reportPloS one2017
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.
Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Non-pharmacological interventions for antipsychotic drug-related metabolic abnormalities: a systematic narrative review.BMC psychiatry · 2026Pooled it
- Systematic review of lifestyle interventions to improve weight, physical activity and diet among people with a mental health condition.Systematic reviews · 2022Pooled it
- Patient-reported outcomes of lifestyle interventions in patients with severe mental illness: a systematic review and meta-analysis.BMC psychiatry · 2022Pooled it
- A systematic review of interventions aimed at improving the cardiovascular health of people diagnosed with personality disorders.Social psychiatry and psychiatric epidemiology · 2019Pooled it
- Trial
- Characteristics of Patients in Treatment for Alcohol and Drug Addiction Who Succeed in Changing Smoking, Weight, and Physical Activity: A Secondary Analysis of an RCT on Combined Lifestyle Interventions.European addiction research · 2021Trial
- Integrating physical healthcare into psychiatry for severe mental illness: A narrative review and position statement from the ECNP PAN-Health group.Neuroscience applied · 2026Review
- Polygenic risks and cardiovascular treatment effects in severe mental illness.Psychiatric genetics · 2025Article
- Non-pharmacologicaL InterVEntions for Antipsychotic-Induced Weight Gain (RESOLVE) in People Living With Severe Mental Illness: A Realist Synthesis.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2025Review
- Psychosocial Interventions Impact on Cardiometabolic, Neurobiological, Behavioral, and Immune Outcomes in People With a Serious Mental Illness: A Systematic Review.Health science reports · 2025Review
- Implementation of the healthy heart tool- an algorithm with potential cardiometabolic health benefits in persons with severe mental illness.BMC psychiatry · 2025Observational
- Neurobiological Mechanisms Link Bipolar Disorder to Cardiovascular Disease: A Retrospective Biobank Study of Adverse Event Risk and Contributory Mechanisms.Bipolar disorders · 2025Observational
- Predicting cardiovascular disease in patients with mental illness using machine learning.European psychiatry : the journal of the Association of European Psychiatrists · 2025Article
- Severe mental illness: cardiovascular risk assessment and management.European heart journal · 2024Article
- Interventions to Promote the Utilization of Physical Health Care for People with Severe Mental Illness: A Scoping Review.International journal of environmental research and public health · 2022Article
- Article
- Cost-Effectiveness of a Multidisciplinary Lifestyle-Enhancing Treatment for Inpatients With Severe Mental Illness: The MULTI Study V.Schizophrenia bulletin open · 2022Article
- Cardiovascular disease in patients with severe mental illness.Nature reviews. Cardiology · 2021Review
- From impact factors to real impact: translating evidence on lifestyle interventions into routine mental health care.Translational behavioral medicine · 2020Article
- Implementation barriers and facilitators of an integrated multidisciplinary lifestyle enhancing treatment for inpatients with severe mental illness: the MULTI study IV.BMC health services research · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.