Can an early weight management program (WMP) prevent olanzapine (OLZ)-induced disturbances in body weight, blood glucose and lipid metabolism? Twenty-four- and 48-week results from a 6-month randomized trial

Cordes, Joachim; Thünker, Johanna; Regenbrecht, Gunnar; Zielasek, Jürgen; Correll, Christoph U.; Schmidt-Kraepelin, Christian; Lange-Asschenfeldt, Christian; Agelink, M.W.; Kahl, Kai G.; Gäebel, Wolfgang; Klimke, A.; Hauner, Hans

doi:10.3109/15622975.2011.592546

Cited by 24 publications

(84 citation statements)

References 45 publications

(50 reference statements)

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“…Weight reduction is the most used outcome and the evidence is reported to be favourable, although long‐term trials are missing. 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. 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.…”

Section: Discussioncontrasting

confidence: 68%

“…Trials evaluating the effect of behavioural interventions in reducing metabolic risk factors have shown mixed results. Weight reduction is the most used outcome and the evidence is reported to be favourable, although long‐term trials are missing. 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.…”

Section: Discussionmentioning

confidence: 99%

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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

et al. 2016

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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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Section: Discussioncontrasting

confidence: 68%

Section: Discussionmentioning

confidence: 99%

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

et al. 2016

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“…Among the non-pharmacological studies, six compared an intervention with usual care [21, 22, 25, 27, 30, 32], and three provided basic information or advice to controls at baseline [23, 26, 29]. In one study, the intervention was also given to the control group after week 12 of 24 weeks [28].…”

Section: Resultsmentioning

confidence: 99%

The Effectiveness of Pharmacological and Non-Pharmacological Interventions for Improving Glycaemic Control in Adults with Severe Mental Illness: A Systematic Review and Meta-Analysis

et al. 2017

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People with severe mental illness (SMI) have reduced life expectancy compared with the general population, which can be explained partly by their increased risk of diabetes. We conducted a meta-analysis to determine the clinical effectiveness of pharmacological and non-pharmacological interventions for improving glycaemic control in people with SMI (PROSPERO registration: CRD42015015558). A systematic literature search was performed on 30/10/2015 to identify randomised controlled trials (RCTs) in adults with SMI, with or without a diagnosis of diabetes that measured fasting blood glucose or glycated haemoglobin (HbA1c). Screening and data extraction were carried out independently by two reviewers. We used random effects meta-analysis to estimate effectiveness, and subgroup analysis and univariate meta-regression to explore heterogeneity. The Cochrane Collaboration’s tool was used to assess risk of bias. We found 54 eligible RCTs in 4,392 adults (40 pharmacological, 13 behavioural, one mixed intervention). Data for meta-analysis were available from 48 RCTs (n = 4052). Both pharmacological (mean difference (MD), -0.11mmol/L; 95% confidence interval (CI), [-0.19, -0.02], p = 0.02, n = 2536) and behavioural interventions (MD, -0.28mmol//L; 95% CI, [-0.43, -0.12], p<0.001, n = 956) were effective in lowering fasting glucose, but not HbA1c (pharmacological MD, -0.03%; 95% CI, [-0.12, 0.06], p = 0.52, n = 1515; behavioural MD, 0.18%; 95% CI, [-0.07, 0.42], p = 0.16, n = 140) compared with usual care or placebo. In subgroup analysis of pharmacological interventions, metformin and antipsychotic switching strategies improved HbA1c. Behavioural interventions of longer duration and those including repeated physical activity had greater effects on fasting glucose than those without these characteristics. Baseline levels of fasting glucose explained some of the heterogeneity in behavioural interventions but not in pharmacological interventions. Although the strength of the evidence is limited by inadequate trial design and reporting and significant heterogeneity, there is some evidence that behavioural interventions, antipsychotic switching, and metformin can lead to clinically important improvements in glycaemic measurements in adults with SMI.

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“…83 A RCT of a diet, physical activity and behavioural support intervention also reported a significant reduction on waist circumference. 79 One trial reporting significant effects on weight and BMI immediately after the intervention period reported no effect at 12 months. 62 Three RCTs, one of a group diet and physical activity intervention, one providing free fruit and vegetables to participants for 6 months, and one of a nutrition, physical activity and contingency management intervention [two arms: (1) payment for weight loss and (2) payment for attendance] reported no effect on weight or BMI.…”

Section: Systematic Reviews Of Behavioural Interventions Targeting Wementioning

confidence: 99%

“…Two RCTs, one of a nutrition, physical activity and behavioural support intervention, and one of nutrition, physical activity and contingency management, both reported no effect on the levels of triglycerides or total cholesterol. 79,86 Three RCTs examined the effect of behavioural interventions on glucose: two reported no effect, 82,86 and one reported a significant reduction in the intervention arm. 62 One RCT examining the effects of interventions on blood pressure reported no effect.…”

Section: Systematic Reviews Of Behavioural Interventions Targeting Wementioning

confidence: 99%

Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

Osborn

Burton

Walters

et al. 2019

Programme Grants Appl Res

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Background Effective interventions are needed to prevent cardiovascular disease (CVD) in people with severe mental illnesses (SMI) because their risk of CVD is higher than that of the general population. Objectives (1) Develop and validate risk models for predicting CVD events in people with SMI and evaluate their cost-effectiveness, (2) develop an intervention to reduce levels of cholesterol and CVD risk in SMI and (3) test the clinical effectiveness and cost-effectiveness of this new intervention in primary care. Design Mixed methods with patient and public involvement throughout. The mixed methods were (1) a prospective cohort and risk score validation study and cost-effectiveness modelling, (2) development work (focus groups, updated systematic review of interventions, primary care database studies investigating statin prescribing and effectiveness) and (3) cluster randomised controlled trial (RCT) assessing the clinical effectiveness and cost-effectiveness of a new practitioner-led intervention, and fidelity assessment of audio-recorded appointments. Setting General practices across England. Participants All studies included adults with SMI (schizophrenia, bipolar disorder or other non-organic psychosis). The RCT included adults with SMI and two or more CVD risk factors. Interventions The intervention consisted of 8–12 appointments with a practice nurse/health-care assistant over 6 months, involving collaborative behavioural approaches to CVD risk factors. The intervention was compared with routine practice with a general practitioner (GP). Main outcome measures The primary outcome for the risk score work was CVD events, in the cost-effectiveness modelling it was quality-adjusted life-years (QALYs) and in the RCT it was level of total cholesterol. Data sources Databases studies used The Health Improvement Network (THIN). Intervention development work included focus groups and systematic reviews. The RCT collected patient self-reported and routine NHS GP data. Intervention appointments were audio-recorded. Results Two CVD risk score models were developed and validated in 38,824 people with SMI in THIN: the Primrose lipid model requiring cholesterol levels, and the Primrose body mass index (BMI) model with no blood test. These models performed better than published Cox Framingham models. In health economic modelling, the Primrose BMI model was most cost-effective when used as an algorithm to drive statin prescriptions. Focus groups identified barriers to, and facilitators of, reducing CVD risk in SMI including patient engagement and motivation, staff confidence, involving supportive others, goal-setting and continuity of care. Findings were synthesised with evidence from updated systematic reviews to create the Primrose intervention and training programme. THIN cohort studies in 16,854 people with SMI demonstrated that statins effectively reduced levels of cholesterol, with similar effect sizes to those in general population studies over 12–24 months (mean decrease 1.2 mmol/l). Cluster RCT: 76 GP practices were randomised to the Primrose intervention (n = 38) or treatment as usual (TAU) (n = 38). The primary outcome (level of cholesterol) was analysed for 137 out of 155 participants in Primrose and 152 out of 172 in TAU. There was no difference in levels of cholesterol at 12 months [5.4 mmol/l Primrose vs. 5.5 mmol/l TAU; coefficient 0.03; 95% confidence interval (CI) –0.22 to 0.29], nor in secondary outcomes related to cardiometabolic parameters, well-being or medication adherence. Mean cholesterol levels decreased over 12 months in both arms (–0.22 mmol/l Primrose vs. –0.39 mmol/l TAU). There was a significant reduction in the cost of inpatient mental health attendances (–£799, 95% CI –£1480 to –£117) and total health-care costs (–£895, 95% CI –£1631 to –£160; p = 0.012) in the intervention group, but no significant difference in QALYs (–0.011, 95% CI –0.034 to 0.011). A total of 69% of patients attended two or more Primrose appointments. Audiotapes revealed moderate fidelity to intervention delivery (67.7%). Statin prescribing and adherence was rarely addressed. Limitations RCT participants and practices may not represent all UK practices. CVD care in the TAU arm may have been enhanced by trial procedures involving CVD risk screening and feedback. Conclusions SMI-specific CVD risk scores better predict new CVD if used to guide statin prescribing in SMI. Statins are effective in reducing levels of cholesterol in people with SMI in UK clinical practice. This primary care RCT evaluated an evidence-based practitioner-led intervention that was well attended by patients and intervention components were delivered. No superiority was shown for the new intervention over TAU for level of cholesterol, but cholesterol levels decreased over 12 months in both arms and the intervention showed fewer inpatient admissions. There was no difference in cholesterol levels between the intervention and TAU arms, which might reflect better than standard general practice care in TAU, heterogeneity in intervention delivery or suboptimal emphasis on statins. Future work The new risk score should be updated, deployed and tested in different settings and compared with the latest versions of CVD risk scores in different countries. Future research on CVD risk interventions should emphasise statin prescriptions more. The mechanism behind lower costs with the Primrose intervention needs exploring, including SMI-related training and offering frequent support to people with SMI in primary care. Trial registration Current Controlled Trials ISRCTN13762819. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 7, No. 2. See the NIHR Journals Library website for further project information. Professor David Osborn is supported by the University College London Hospital NIHR Biomedical Research Centre and he was also in part supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Barts Health NHS Trust.

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Can an early weight management program (WMP) prevent olanzapine (OLZ)-induced disturbances in body weight, blood glucose and lipid metabolism? Twenty-four- and 48-week results from a 6-month randomized trial

Abstract: These results suggest that preventive WMP may reduce the risk of abdominal obesity and deterioration of glucose metabolism in OLZ-treated patients.

Cited by 24 publications

References 45 publications

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

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

The Effectiveness of Pharmacological and Non-Pharmacological Interventions for Improving Glycaemic Control in Adults with Severe Mental Illness: A Systematic Review and Meta-Analysis

Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

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