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Cited by 153Schizophrenia research and treatmentCardiac Health and Mental HealthObesity, Physical Activity, Diet

The CHANGE trial: no superiority of lifestyle coaching plus care coordination plus treatment as usual compared to treatment as usual alone in reducing risk of cardiovascular disease in adults with schizophrenia spectrum disorders and abdominal obesity

Open access
Speyer, Helene, Christian Brix Nørgaard, Hans, Birk, Merete, Karlsen, Mette, Storch Jakobsen, Ane, Pedersen, Kamilla, Hjorthøj, Carsten, Pisinger, Charlotta +4 more·2016·World Psychiatry
DOI 10.1002/wps.20318PMC PMC4911772
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Abstract

Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel‐group, superiority, multi‐centre trial with blinded outcome assessment, testing the efficacy of an intervention aimed to improve cardiovascular risk profile and hereby potentially reduce mortality. A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and centrally randomized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual (N=138), or care coordination plus treatment as usual (N=142), or treatment as usual alone (N=148). The primary outcome was 10‐year risk of cardiovascular disease assessed post‐treatment and standardized to age 60. At follow‐up, the mean 10‐year risk of cardiovascular disease was 8.4 ± 6.7% in the group receiving lifestyle coaching, 8.5 ± 7.5% in the care coordination group, and 8.0 ± 6.5% in the treatment as usual group (p=0.41). We found no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal obesity.

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Written from the paper’s full text.

TL;DR

The CHANGE trial found that 12 months of lifestyle coaching plus care coordination plus treatment as usual, or care coordination plus treatment as usual, was not superior to treatment as usual alone in reducing 10-year cardiovascular disease risk in adults with schizophrenia spectrum disorders and abdominal obesity. No intervention effects were found for secondary or exploratory outcomes, including cardiorespiratory fitness, weight, diet, and smoking.

Key findings

  • Among 428 randomized participants, mean age-standardized 10-year cardiovascular disease risk at follow-up was 8.4 ± 6.7% with lifestyle coaching, 8.5 ± 7.5% with care coordination, and 8.0 ± 6.5% with treatment as usual (p = 0.41).
  • There were no differences for the key secondary outcome, cardiorespiratory fitness: 18.1 ± 5.5, 18.0 ± 6.8, and 18.2 ± 6.7 ml O₂/min/kg, respectively (p = 0.54).
  • No significant differences were found for exploratory outcomes, including weight (103.1 ± 23.8 kg, 103.7 ± 21.2 kg, and 102.9 ± 21.7 kg; p = 0.18) and daily smoking (49.0%, 49.0%, and 50.0%).
  • Psychiatric hospitalizations were 18.8% in the CHANGE group, 33.8% in the care coordination group, and 24.3% in treatment as usual; the difference between care coordination and CHANGE was statistically significant (p = 0.004).

Methods

  • Randomized, parallel-group, superiority, multi-centre trial with blinded outcome assessment; 428 adults with schizophrenia spectrum disorders and abdominal obesity were centrally randomized 1:1:1 to lifestyle coaching plus care coordination plus treatment as usual (N = 138), care coordination plus treatment as usual (N = 142), or treatment as usual alone (N = 148).
  • Participants were recruited from catchment areas in Aarhus and Copenhagen, Denmark; eligibility included ICD-10 schizophrenia, schizoaffective disorder, or persistent delusional disorder and waist circumference above 88 cm for women and 102 cm for men.
  • Primary outcome was 10-year risk of cardiovascular disease assessed post-treatment and standardized to age 60 using the Copenhagen risk score; analysis was intention-to-treat with multiple imputation and ANCOVA, with Bonferroni-adjusted alpha of 0.0167 for the primary outcome.

Limitations

  • The paper states that recruitment stopped at 428 participants instead of the planned 450, so underpowering and type II error cannot be excluded, although the authors report 87.2% power for the primary outcome.
  • The paper states that the surrogate cardiovascular risk score lacks validation in schizophrenia, that lifestyle measures were not validated in this population, and that self-report may introduce recall and social desirability bias.
  • The paper states that generalizability of care coordination may be limited to countries with similar healthcare systems; it also notes that patients and intervention staff were not blinded, while outcome assessors, statisticians, and investigators were blinded.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1002/wps.20318

Cites

59 of 59 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 30 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    The means for cardiorespiratory fitness were 18.1±5.5 ml O2/min/Kg in the CHANGE group, 18.0±6.8 ml O2/min/Kg in the care coordination group, and 18.2±6.7 ml O2/min/Kg in the treatment as usual group (F=0.86, p=0.54).

    “The means for cardiorespiratory fitness, our key secondary outcome, were 18.1 6 5.5 ml O 2 / min/Kg in the CHANGE group, 18.0 6 6.8 ml O 2 /min/Kg in the care coordination group, and 18.2 6 6.7 ml O 2 /min/Kg in the treatment as usual group (F 2,428 50.86, p50.54).”
    Quote in the paperNot a substantial claim
  • Findingown data

    After removing outliers, the mean age-standardized 10-year risk was 7.9±5.2% in the CHANGE group, 7.6±4.9% in the care coordination group and 7.1±4.1% in the treatment as usual group (p=0.18).

    “After removing outliers, we found that it was 7.9 6 5.2% in the CHANGE group, 7.6 6 4.9% in the care coordination group and 7.1 6 4.1% in the treatment as usual group (p50.18).”
    Quote in the paperSubstantial claim
  • Findingown data

    The mean age-standardized 10-year risk of cardiovascular disease at follow-up was 8.4±6.7% in the lifestyle coaching group, 8.5±7.5% in the care coordination group, and 8.0±6.5% in the treatment as usual group (p=0.41).

    “At follow-up, the mean 10-year risk of cardiovascular disease was 8.4 6 6.7% in the group receiving lifestyle coaching, 8.5 6 7.5% in the care coordination group, and 8.0 6 6.5% in the treatment as usual group (p50.41).”
    Quote in the paperSubstantial claim
  • Findingown data

    The CHANGE trial provides evidence that a manual-based individual lifestyle coaching intervention does not reduce the 10-year risk of cardiovascular disease, compared with treatment as usual, in patients with schizophrenia spectrum disorders and abdominal obesity.

    “In conclusion, the CHANGE trial provides evidence that a manual-based individual lifestyle coaching intervention does not reduce the 10-year risk of cardiovascular disease, compared with treatment as usual, in patients with schizophrenia spectrum disorders and abdominal obesity.”
    Quote in the paperSubstantial claim
  • Findingown data

    Somatic hospitalizations amounted to 12.3% in the CHANGE group, 17.6% in the care coordination group and 16.2% in the control group (p=0.40).

    “Somatic hospitalizations amounted to 12.3% in the CHANGE group, 17.6% in the care coordination group and 16.2% in the control group (p50.40).”
    Quote in the paperNot a substantial claim
  • May combine two claims. 23
  • Classified as probably not a substantial claim. 39
  • The quote only partly states this claim. 1

  • May combine two claims.

    Findingown data

    Psychiatric hospitalizations amounted to 18.8% in the CHANGE group, 33.8% in the care coordination group and 24.3% in the treatment as usual group; the difference between the care coordination and the CHANGE group was statistically significant (p=0.004).

    “Psychiatric hospitalizations amounted to 18.8% in the CHANGE group, 33.8% in the care coordination group and 24.3% in the treatment as usual group; the difference between the care coordination and the CHANGE group was statistically significant (p50.004).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Five patients died during the trial.

    “Five patients died during the trial.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and centrally randomized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual, or care coordination plus treatment as usual, or treatment as usual alone.

    “A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and centrally randomized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual (N5138), or care coordination plus treatment as usual (N5142), or treatment as usual alone (N5148).”
    • Also stated in: § RESULTS · plain
      “Between December 2012 and May 2014, 428 participants were assigned to receive the CHANGE intervention (N5138), or care coordination plus treatment as usual (N5142), or treatment as usual alone (N5148).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The proportion of daily smokers was 49.0% in the CHANGE group, 49.0% in the care coordination group, and 50.0% in the treatment as usual group (CHANGE vs TAU p=0.65; care coordination vs TAU p=0.79).

    “The proportion of daily smokers was 49.0% in the CHANGE group, 49.0% in the care coordination group, and 50.0% in the treatment as usual group (CHANGE group vs. treatment as usual group: p50.65; care coordination group vs. treatment as usual group: p50.79).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    In the CHANGE group, the mean number of personal meetings was 24.6±14.5; 60.0% attended 21 or more of the intended 42 personal meetings; 97.8% had at least one personal meeting with their coach.

    “In the CHANGE group, the mean number of personal meetings was 24.6 6 14.5; 60.0% of the participants attended 21 or more of the intended 42 personal meetings; 97.8% had at least one personal meeting with their coach.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Follow-ups after the intervention has ended are important, as the effect of lifestyle modification tends to vanish, and an intentional weight loss may be followed by an unhealthy weight gain in the majority of participants in behavioural trials.

    “Equally important are follow-ups after the intervention has ended, as the effect of lifestyle modification tends to vanish, and an intentional weight loss may be followed by an unhealthy weight gain in the majority of participants in behavioural trials 19 .”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [19] source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductown data

    CHANGE was a randomized, parallel-group, superiority, multi-centre trial with blinded outcome assessment.

    “CHANGE was a randomized, parallel-group, superiority, multi-centre trial with blinded outcome assessment”
    • Also stated in: § Study design and participants · plain
      “CHANGE was an investigator-initiated, independently funded, randomized, parallel-group, superiority, multi-centre trial with blinded outcome assessment.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Premisecitation

    Interventions with long-term follow-up are warranted, since there are no reasons to believe that changes in metabolic risk factors occur faster in patients with severe mental disorders than the general population.

    “Interventions with long-term follow-up are also warranted, since there are no reasons to believe that changes in metabolic risk factors occur faster in patients with severe mental disorders than the general population 18 .”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [18] source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    The trial protocol was published in 2015 with no changes made to the original version.

    “The trial protocol was published in 2015 with no changes made to the original version 21 .”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [21] source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The trial had to stop before the planned 450 participants due to lack of referrals.

    “According to the protocol, we ought to include 450 participants, but had to stop before, due to lack of referrals.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    About 60% of excess mortality in schizophrenia is due to physical illnesses, with cardiovascular disease being dominant.

    “About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant.”
    • Also stated in: § Abstract · plain
      “About 60% of the premature mortality in schizophrenia is due to physical diseases 3 , with cardiovascular disease explaining the majority 4 .”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [3] source

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    • cites [4] source

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  • Probably not a substantial claim: may not pass S2 (checkable).

    Premisecitation

    Since the pathogenesis of cardiovascular disease is multifactorial, strategies to reduce multiple, concurrent risk behaviours are needed.

    “Moreover, since the pathogenesis of cardiovascular disease is multifactorial, strategies to reduce multiple, concurrent risk behaviours are needed 17 .”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [17]

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  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Composite surrogate outcomes assessing the risk of cardiovascular disease have been proposed.

    “To overcome this, composite surrogate outcomes assessing the risk of cardiovascular disease have been proposed 16 .”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [16] source

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  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    The authors' negative results might be explained by better access to primary care in Denmark.

    “Our negative results might be explained by better access to primary care in Denmark.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    For the primary outcome, p values were Bonferroni-adjusted (alpha level 0.05/3=0.0167).

    “For the primary outcome, the p values were Bonferroni-adjusted (alpha level50.05/350.0167).”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Interpretationreasoning

    Insufficient treatment of somatic comorbidity and unhealthy lifestyle are potentially fully modifiable and, if properly targeted, life expectancy for patients with schizophrenia might improve.

    “Insufficient treatment of somatic comorbidity and unhealthy lifestyle are potentially fully modifiable and, if they are properly targeted, life expectancy for patients with schizophrenia might improve.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    The primary outcome used the Copenhagen risk score, which is recommended by the European Society of Cardiology for screening of cardiovascular risk.

    “We used the Copenhagen risk score, which is based on data from two large epidemiological studies in the Copenhagen area 16 and is recommended by the European Society of Cardiology for screening of cardiovascular risk 29 .”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [16] source

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    • cites [29] source

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    • Rests on an assumption: The Copenhagen risk score is a valid measure of 10-year cardiovascular disease risk in patients with schizophrenia spectrum disorders and abdominal obesity.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population.

    “Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population.”
    • Also stated in: § Abstract · plain
      “The gap in life expectancy between patients with schizophrenia and the general population -twenty years shorter for men and fifteen years shorter for women 1,2 -is a major challenge to public health.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [1] source

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    • cites [2] source

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  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    The sample size was estimated to recruit 150 participants per group, total 450, with 90% power and alpha level 0.0167.

    “Allowing a power of 90%, we estimated to recruit 150 participants to each intervention group, a total of 450 participants.”
    • Also stated in: § Statistical analysis · plain
      “we reduced our alpha level to 0.05/3 5 0.0167.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Retention proportion was 86.0% for the sample as a whole.

    “Retention proportion was 86.0% for the sample as a whole.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    Dropouts did not differ from completers regarding baseline metabolic or psychometric characteristics or pattern of medication, except for a smaller proportion of the former receiving antidepressant treatment (30.0% vs. 46.0%).

    “The dropouts did not differ from completers regarding baseline metabolic or psychometric characteristics or pattern of medication, except for a smaller proportion of the former receiving antidepressant treatment (30.0% vs. 46.0%).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    365 participants (85.3%) provided information enabling a calculation of the primary outcome at follow-up.

    “365 participants (85.3%) provided information enabling a calculation of the primary outcome at follow-up.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Randomization was centralized and carried out by the Copenhagen Trial Unit using a computerized sequence with alternating block sizes (9, 12 and 15) unknown to the investigators.

    “The randomization was centralized and carried out by the Copenhagen Trial Unit using a computerized sequence with alternating block sizes (9, 12 and 15) unknown to the investigators.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    The primary outcome analysis was an intention-to-treat one.

    “The primary outcome analysis was an intention-to-treat one.”
    Quote in the paperSubstantial claim

  • May combine two claims. The quote only partly states this claim.

    Study design and conductown data

    Sensitivity analyses of the primary outcome using complete cases, removing outliers, and per-protocol analyses did not change the results.

    “The sensitivity analyses of the primary outcome using complete cases, or removing outliers, did not change the results.”
    • Also stated in: § RESULTS · plain
      “Equally, the per-protocol analysis removing the three participants with no contact at all to the coach did not change the results.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Several clinical trials have reported an effect of lifestyle modification in this population, indicating that weight reduction and smoking cessation are possible.

    “Several clinical trials [12][13][14] have reported an effect of lifestyle modification in this population, indicating that weight reduction and smoking cessation are possible.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [12][13][14]

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Outcome assessors, statisticians and all investigators involved in the trial were blinded to patient allocation, but patients and the health professionals providing the interventions were not.

    “Outcome assessors, statisticians and all investigators involved in the trial were blinded to patient allocation, but patients and the health professionals providing the interventions were not.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    Several factors contribute to the early and frequent development of cardiovascular disease in this population, including genetic vulnerability, metabolic adverse effects of antipsychotics, insufficient treatment of somatic comorbidity, and unhealthy lifestyle.

    “Several factors contribute to the early and frequent development of cardiovascular disease in this population, including genetic vulnerability 5 , metabolic adverse effects of antipsychotics 6,7 , insufficient treatment of somatic comorbidity 8 , and unhealthy lifestyle 9 .”
    Quote in the paperSubstantial claim0 of 4 sources checked
    • cites [5] source

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    • cites [6] source

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    • cites [8] source

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  • May combine two claims.

    Study design and conductown data

    Baseline characteristics were mostly balanced between groups, but the treatment as usual group had a higher proportion of participants living in supported housings (16.9% vs. 8.7%) and a smaller proportion having diabetes (9.5% vs. 18.6%) compared with the CHANGE group.

    “There were no differences between the intervention groups, apart from a higher proportion of participants living in supported housings (16.9% vs. 8.7%) and a smaller proportion having diabetes (9.5% vs. 18.6%) in the treatment as usual group compared with the CHANGE group.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Multiple imputation was used to handle missing data.

    “Multiple imputation was used to handle missing data.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Missing data were missing at random.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The intervention was developed to be sustainable, using low-budget possibilities in the neighbourhood.

    “Ninth, the intervention was developed to be sustainable, using low-budget possibilities in the neighbourhood.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The trial had independent funding.

    “First, the design had central randomization; blinded outcome assessments, data management and data analysis; and independent funding.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The authors planned their sample size to avoid substantial type II errors.

    “Second, we planned our sample size to avoid substantial type II errors.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    The methods used to intervene reflect the chosen outcome variables.

    “The methods used to intervene reflect the chosen outcome variables.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Weight reduction is the most used outcome in trials of behavioural interventions, and the evidence is reported to be favourable, although long-term trials are missing.

    “Weight reduction is the most used outcome [46][47][48][49][50][51][52][53][54][55] and the evidence is reported to be favourable 17 , although long-term trials are missing 18 .”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [17]

      Not checked in the free run.

    • cites [18] source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Trials exploring the effect of behavioural interventions frequently use dyslipidaemia, haemoglobin A1c and blood pressure as secondary outcomes, and the evidence is currently low or inadequate.

    “Trials exploring the effect of behavioural interventions frequently use dyslipidaemia 46,47,49,52 , haemoglobin A1c 46,56 and blood pressure 46,49,52,56,57 as secondary outcomes, and the evidence is currently low or inadequate 17 .”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [17]

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  • May combine two claims.

    Interpretationreasoning

    The authors' results are not in line with previous trials regarding weight reduction and cardiorespiratory fitness, which might be explained by the clinical characteristics of their sample and the type of intervention.

    “Thus, our results are not in line with previous trials regarding weight reduction and cardiorespiratory fitness, which might be explained by the clinical characteristics of our sample and the type of intervention.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Trials evaluating the effect of behavioural interventions in reducing metabolic risk factors have shown mixed results.

    “Trials evaluating the effect of behavioural interventions in reducing metabolic risk factors have shown mixed results 17 .”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [17]

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    All contacts with patients were registered.

    “Eighth, all contacts with patients were registered.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationnone given

    The authors cannot exclude that selecting a subgroup with more severe somatic comorbidities might have changed their results in favour of care coordination or CHANGE intervention.

    “Also, we cannot exclude that selecting a subgroup with more severe somatic comorbidities might have changed our results in favour of care coordination or CHANGE intervention.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Self-reporting might be subject to recall problems and social desirability bias.

    “As self-reporting might be subject to both recall problems (introducing random errors and thus increasing the risk of type II errors) and social desirability bias (leading to systematic errors)”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Few studies have evaluated the effect of lifestyle interventions on cardiorespiratory fitness in patients with schizophrenia, but they reported promising findings.

    “For our key secondary outcome, cardiorespiratory fitness, few studies have evaluated the effect of lifestyle interventions in patients with schizophrenia, but they reported promising findings [43][44][45] .”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [43] source

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    • cites [44] source

      Not checked in the free run.

    • cites [45] source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    The sample might differ from previous trials because the authors aimed to optimize external validity by having few exclusion criteria, being assertive in recruitment, and offering an intervention without mandatory elements, to avoid exclusion of the severely ill and volunteer bias.

    “Our sample might differ from previous trials, as we aimed to optimize the external validity by having as few exclusion criteria as possible, being assertive in the process of recruitment, and offering an intervention without mandatory elements, in order to avoid exclusion of the severely ill (many trials exclude patients with somatic comorbidity, substance abuse or suicidal ideation) and volunteer”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The authors used a manual-based, well-described and evidence-based theoretical framework.

    “Third, we used a manual-based, well-described and evidence-based theoretical framework.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The clinical characteristics of the sample recruited reflect the inclusion and exclusion criteria.

    “The clinical characteristics of the sample we recruited reflect our inclusion and exclusion criteria.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    By comparing lifestyle coaching with care coordination, the authors were able to differentiate between the effect of lifestyle changes and that of sufficient monitoring and treatment of somatic comorbidities.

    “Seventh, by comparing lifestyle coaching with care coordination, we were able to differentiate between the effect of lifestyle changes and that of sufficient monitoring and treatment of somatic comorbidities.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The design had central randomization.

    “First, the design had central randomization; blinded outcome assessments, data management and data analysis; and independent funding.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    The authors had a multifaceted method, allowing staff to work on all known risk factors.

    “Fifth, we had a multifaceted method, allowing the staff to work on all the known risk factors.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The authors implemented a high-intensity intervention, offering an assertive approach with at least weekly personal contact.

    “Fourth, we implemented a high-intensity intervention, offering an assertive approach with at least weekly personal contact.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Interpretationreasoning

    The low prevalence of baseline risk factors might be the result of a successful mandatory examination of blood lipids in the Danish Schizophrenia database, encouraging clinicians to treat risk factors.

    “This might be the result of a successful mandatory examination of blood lipids in the Danish Schizophrenia database, encouraging all clinicians across the three intervention groups to treat risk factors.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The composite outcome measure integrated the results even though they might be heterogeneous.

    “Sixth, our composite outcome measure integrated the results even though they might be heterogeneous.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Currently there is no gold standard for surrogate outcomes in trials aiming to improve cardiovascular health.
    • Rests on an assumption: The ideal outcome measures for trials aiming to reduce mortality from cardiovascular disease are hard ones like death.
    • Rests on an assumption: Waiting for survival analyses is too time consuming and expensive for most studies.
    • Rests on an assumption: Constructing a risk score without non-modifiable risk factors would not yield an accurate estimate of risk.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    More direct measurements like actigraphs would have been preferable, but they were not considered in this study due to logistic reasons.

    “more direct measurements like actigraphs would have been preferable, but they were not considered in this study due to logistic reasons.”
    Quote in the paperNot a substantial claim
52 of 52

  • The paper relies on this without support.

    Missing data were missing at random.

    “Multiple imputation was used to handle missing data.”
    “The imputations were based on a linear regression model with 100 imputations and 20 iterations.”

  • The paper relies on this without support.

    The Copenhagen risk score is a valid measure of 10-year cardiovascular disease risk in patients with schizophrenia spectrum disorders and abdominal obesity.

    “We used the Copenhagen risk score, which is based on data from two large epidemiological studies in the Copenhagen area 16 and is recommended by the European Society of Cardiology for screening of cardiovascular risk 29 .”

  • The authors state this as an assumption.

    No prior trial has evaluated the effect of lifestyle interventions on a composite score estimating cardiovascular disease risk in patients with schizophrenia spectrum disorders.

    “CHANGE is the first trial, to our knowledge, to evaluate the effect of lifestyle interventions on a composite score estimating the risk of cardiovascular disease in patients with For dichotomous outcomes, a mean difference in risk ratios was calculated using the risk ratio in the TAU group as reference schizophrenic spectrum disorders.”

  • The paper relies on this without support.

    A majority of earlier trials have focused on single risk behaviours, such as diet, smoking or physical inactivity.

    “However, a majority of earlier trials have focused on single risk behaviours, such as diet or smoking or physical inactivity.”

  • The paper relies on this without support.

    The general population, and even more, a vulnerable population like this one, is facing major barriers to making healthy choices and powerful pressures to select the unhealthy.

    “The general population, and even more, a vulnerable population like this one, is facing major barriers to making healthy choices and powerful pressures to select the unhealthy.”

  • The paper relies on this without support.

    Currently there is no gold standard for surrogate outcomes in trials aiming to improve cardiovascular health.

    “Currently there is no gold standard for surrogate outcomes in trials aiming to improve cardiovascular health”

  • The paper relies on this without support.

    The ideal outcome measures for trials aiming to reduce mortality from cardiovascular disease are hard ones like death.

    “The ideal outcome measures for trials aiming to reduce mortality from cardiovascular disease are obviously hard ones like death.”

  • The paper relies on this without support.

    Waiting for survival analyses is too time consuming and expensive for most studies.

    “However, waiting for survival analyses is too time consuming and expensive for most studies”

  • The paper relies on this without support.

    Constructing a risk score without non-modifiable risk factors would not yield an accurate estimate of risk.

    “as constructing a risk score without non-modifiable risk factors would not yield an accurate estimate of risk.”
9 of 9

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • People with severe mental illness experience a range of barriers to engaging in physical activity and exercise, such as high levels of perceived stress, somatic comorbidities, low mood, and a lack of self-confidence and of social support.

    “However, people with severe mental illness experience a range of barriers to engaging in physical activity and exercise, such as high levels of perceived stress, somatic comorbidities, low mood, and a lack of self-confidence and of social support 7-11 .”

    From Sedentary behavior and physical activity levels in people with schizophrenia, bipolar disorder and major depressive disorder: a global systematic review and meta-analysis (2017) · cites this paper as [11]

    The paper’s introductory discussion (page unavailable) recognizes barriers to lifestyle modification among people with severe mental illness, naming cognitive impairment, anxiety, and substance abuse. It does not identify the claimed list—high perceived stress, somatic comorbidities, low mood, low self-confidence, and lack of social support—as barriers specifically to physical activity or exercise. Its measurement of perceived stress does not establish stress as such a barrier. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • The magnitude of weight reduction is similar to the magnitude of weight lost from lifestyle interventions and by adding topiramate or metformin to current antipsychotic medication.

    “On the other hand, the magnitude is similar to the magnitude of weight lost from lifestyle interventions (79, 80) and by adding topiramate or metformin to current antipsychotic medication, all being recommended in clinical guidelines (81).”

    From Reversibility of Antipsychotic-Induced Weight Gain: A Systematic Review and Meta-Analysis (2021) · cites this paper as [80]

    The Discussion (page unavailable) says prior behavioural-intervention trials generally reported favourable weight-reduction results. But the CHANGE trial’s Results (page unavailable) found no significant difference in weight between its lifestyle-coaching and comparison groups, and the paper provides no basis for the claimed similarity in magnitude. The topiramate/metformin clause is attached to a different citation, not this source. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

Cites

Flagged first, then by citations

Research works printed but not linked: 2

  1. World Health Organization, 2008, Waist circumference and waist‐hip ratio: report of a WHO expert consultation
  2. 10.1111/acps.12029 · DOI · Paper page

Cited by

Sorted by citations

Related

Authors
Speyer, H., Christian Brix Nørgaard, H., Birk, M., Karlsen, M., Storch Jakobsen, A., Pedersen, K., Hjorthøj, C., Pisinger, C., Gluud, C., Mors, O., Krogh, J., & Nordentoft, M.
Affiliations
  • University of Copenhagen (DK)
  • Psychosis Research Unit Aarhus University Hospital Risskov Denmark
  • Aarhus University Hospital (DK)
  • Copenhagen University Hospital (DK)
  • Mental Health Centre Copenhagen Copenhagen University Hospital Copenhagen Denmark
  • Aarhus University (DK)
  • Glostrup Hospital (DK)
ORCID
Venue
World Psychiatry
Publisher
Wiley
Published
2016-06
Volume
15
Issue
2
Pages
155-165
ISSN
  • 1723-8617 (ISSN-L)
  • 2051-5545
DOI
10.1002/wps.20318
PMC
PMC4911772
OpenAlex
W2471447259
Cited by
153
References
59
Citations by year
2026: 10 · 2025: 12 · 2024: 9 · 2023: 11 · 2022: 18 · 2021: 14 · 2020: 19 · 2019: 27 · 2018: 18 · 2017: 13 · 2016: 2
FWCI
17.76
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor, 4 d)
Locations
  • World Psychiatry (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
  • Scopus (Elsevier) (submittedVersion)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
Funders
  • Mental Health Services of the Capital Region of Denmark
  • Tryg Foundation
  • Lundbeck Foundation
  • Daehnfeldts Foundation
  • Danish Ministry of Health
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
Keywords
schizophrenia spectrum disorders, abdominal obesity, cardiovascular risk, lifestyle coaching, care coordination, cardiovascular risk profile, physical activity, cardiorespiratory fitness, smoking, diet, weight, usual care

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-10.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-10.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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