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NIHR Signal No additional weight-loss reported from a lifestyle programme for people with psychosis

Published on 12 February 2019

doi: 10.3310/signal-000728

For adults with psychosis, such as schizophrenia, who are taking antipsychotic medication, a carefully designed 12-month group diet and exercise programme did not lead to clinically important weight loss after 12 months. The programme was compared with those receiving usual care including written lifestyle advice. Intervention and usual care groups each lost half a kilo on average, with no measurable changes in diet or physical activity.

People with schizophrenia are twice as likely to be overweight as the general population, as medication side effects frequently include weight gain. This NIHR-funded study with over 400 participants in 10 areas across England is the largest UK randomised trial to date.

It shows that this hard-to-reach group can be recruited and retained in structured self-management programmes delivered by trained facilitators. However, it was neither clinically effective nor cost-effective.

Alternative, affordable approaches are much needed.

Share your views on the research.

Why was this study needed?

About 220,000 people in England and Wales have schizophrenia, a severe enduring mental illness with psychotic symptoms. Drug side effects, limited resources to enable a healthy diet and physical exercise, and self-neglect all contribute to weight problems. Life expectancy is between 15 and 20 years less than for the general population, mainly due to diseases such as heart disease, diabetes and cancers.

In 2015, 8 of 10 surveyed NHS mental health trusts offered group diet and exercise programmes to people with psychosis. Yet there has been no robust UK evidence of their effect on long-term outcomes.

The STEPWISE group self-management programme was based on a programme and manual developed by the Leicester Diabetes Centre for people with diabetes. This trial investigated whether the programme is effective for weight loss in people with schizophrenia, schizoaffective disorder and first episode psychosis.

What did this study do?

This randomised controlled trial included 414 adults taking antipsychotic medication who were overweight or concerned about their weight. Participants were randomly assigned to either the STEPWISE programme or usual healthcare, and all received written lifestyle advice.

Participants were offered a month of weekly core sessions with three-monthly booster sessions for another nine months, and fortnightly one-to-one telephone support throughout. A process evaluation included interviews with 24 participants and 20 facilitators.

Participants had experienced psychotic symptoms for 15 years on average. They did not have relevant physical illnesses, alcohol or drug problems, depression or mania. Before the trial, they had low levels of physical activity and poor diets.

Over 80% of the participants completed this well-designed trial. Outcome assessors did not know which group participants had been allocated to.

What did it find?

  • By 12 months, people who participated in the STEPWISE programme had the same average change in weight as people who did not. The intervention group lost 0.47kg on average, compared to 0.51kg loss in the control group (mean difference [MD] 0.0kg, 95% confidence interval [CI] -1.59kg to 1.67kg). There was also no difference in weight loss by three months.
  • There were also no differences between the intervention and control groups in relation to change in self-reported diet, objectively measured overall activity levels or biomedical measures such as blood sugar.
  • Participants reported that they liked the programme, valued the peer support, and thought that it helped them achieve a healthier diet and weight loss.  However, the number of sessions attended varied, with fewer than a quarter of the intervention group attending all sessions. Some participants said they wanted more ongoing support.
  • Facilitators thought that programme management was under-resourced and may not be sustainable longer-term in the NHS. Turnover of facilitators was high, with 20% leaving over the 40 weeks of the programme.
  • Facilitators would have liked to collect regular weight, biomedical and lifestyle data during the programme so they could more effectively support behaviour change for individuals. Attitudes of family members could be a barrier to patient engagement.

What does current guidance say on this issue?

The 2009 NICE guideline on schizophrenia recommends that mental health services offer a lifestyle programme, in particular to people taking antipsychotic medication. Patients should be monitored regularly for obesity and associated clinical markers. Interventions recommended in the NICE obesity guideline should be given if a person gains weight rapidly or excessively.

NICE 2014 obesity guidelines for the general population recommend that GPs refer people who are obese or overweight to group weight management programmes that last for at least three months, with sessions at least fortnightly. Programmes should be multi-component, addressing diet, physical activity and behaviour change.

What are the implications?

A carefully designed supported lifestyle management programme did not help people with schizophrenia to lose weight.  Though there were some individual successes, overall the STEPWISE programme was not effective and expensive, costing £246,921 per QALY gained. It is not known which programme components work best for whom or whether a more intensive programme would be effective. This remains a challenging problem.

The process evaluation alongside the trial provided useful information for anyone wanting to build on this intervention in future studies. This high-quality trial showed that lifestyle interventions which have been helpful for other patient populations, like those with diabetes, did not prove effective for people with schizophrenia.  More intense or tailored lifestyle programmes combined with careful management of antipsychotic medication may be needed for this group at high risk of obesity.

Citation and Funding

Holt R, Hind D, Gossage-Worrall R, Bradburn M et al. Structured lifestyle education to support weight loss for people with schizophrenia, schizoaffective disorder and first episode psychosis: the STEPWISE RCT. Health Technol Assess. 2018;22(65):1-160.

This project was funded by the National Institute for Health Research Health Technology Programme (project number 12/28/05).

Bibliography

NHS website. Schizophrenia. London: Department of Health and Social Care; updated 2016.

NHS website. Obesity: treatment. London: Department of Health and Social Care; updated 2016.

NICE. Psychosis and schizophrenia in adults: prevention and management. CG178. London: National Institute for Health and Care Excellence; 2014.

NICE. Weight management: lifestyle services for overweight or obese adults. PH53. National Institute for Health and Care Excellence; 2014.

NICE. Obesity: identification, assessment and management. CG189. London: National Institute for Health and Care Excellence; 2014.

Swaby L, Hind D, Gossage-Worrall R et al. Adherence to NICE guidance on lifestyle advice for people with schizophrenia: a survey. BJPsych Bulletin. 2016;40(5);1-8.

Naslund J, Whiteman K, McHugo G et al. Lifestyle interventions for weight loss among overweight and obese adults with serious mental illness: a systematic review and meta-analysis. Gen Hosp Psychiatry.2017;47:83-102.

Why was this study needed?

About 220,000 people in England and Wales have schizophrenia, a severe enduring mental illness with psychotic symptoms. Drug side effects, limited resources to enable a healthy diet and physical exercise, and self-neglect all contribute to weight problems. Life expectancy is between 15 and 20 years less than for the general population, mainly due to diseases such as heart disease, diabetes and cancers.

In 2015, 8 of 10 surveyed NHS mental health trusts offered group diet and exercise programmes to people with psychosis. Yet there has been no robust UK evidence of their effect on long-term outcomes.

The STEPWISE group self-management programme was based on a programme and manual developed by the Leicester Diabetes Centre for people with diabetes. This trial investigated whether the programme is effective for weight loss in people with schizophrenia, schizoaffective disorder and first episode psychosis.

What did this study do?

This randomised controlled trial included 414 adults taking antipsychotic medication who were overweight or concerned about their weight. Participants were randomly assigned to either the STEPWISE programme or usual healthcare, and all received written lifestyle advice.

Participants were offered a month of weekly core sessions with three-monthly booster sessions for another nine months, and fortnightly one-to-one telephone support throughout. A process evaluation included interviews with 24 participants and 20 facilitators.

Participants had experienced psychotic symptoms for 15 years on average. They did not have relevant physical illnesses, alcohol or drug problems, depression or mania. Before the trial, they had low levels of physical activity and poor diets.

Over 80% of the participants completed this well-designed trial. Outcome assessors did not know which group participants had been allocated to.

What did it find?

  • By 12 months, people who participated in the STEPWISE programme had the same average change in weight as people who did not. The intervention group lost 0.47kg on average, compared to 0.51kg loss in the control group (mean difference [MD] 0.0kg, 95% confidence interval [CI] -1.59kg to 1.67kg). There was also no difference in weight loss by three months.
  • There were also no differences between the intervention and control groups in relation to change in self-reported diet, objectively measured overall activity levels or biomedical measures such as blood sugar.
  • Participants reported that they liked the programme, valued the peer support, and thought that it helped them achieve a healthier diet and weight loss.  However, the number of sessions attended varied, with fewer than a quarter of the intervention group attending all sessions. Some participants said they wanted more ongoing support.
  • Facilitators thought that programme management was under-resourced and may not be sustainable longer-term in the NHS. Turnover of facilitators was high, with 20% leaving over the 40 weeks of the programme.
  • Facilitators would have liked to collect regular weight, biomedical and lifestyle data during the programme so they could more effectively support behaviour change for individuals. Attitudes of family members could be a barrier to patient engagement.

What does current guidance say on this issue?

The 2009 NICE guideline on schizophrenia recommends that mental health services offer a lifestyle programme, in particular to people taking antipsychotic medication. Patients should be monitored regularly for obesity and associated clinical markers. Interventions recommended in the NICE obesity guideline should be given if a person gains weight rapidly or excessively.

NICE 2014 obesity guidelines for the general population recommend that GPs refer people who are obese or overweight to group weight management programmes that last for at least three months, with sessions at least fortnightly. Programmes should be multi-component, addressing diet, physical activity and behaviour change.

What are the implications?

A carefully designed supported lifestyle management programme did not help people with schizophrenia to lose weight.  Though there were some individual successes, overall the STEPWISE programme was not effective and expensive, costing £246,921 per QALY gained. It is not known which programme components work best for whom or whether a more intensive programme would be effective. This remains a challenging problem.

The process evaluation alongside the trial provided useful information for anyone wanting to build on this intervention in future studies. This high-quality trial showed that lifestyle interventions which have been helpful for other patient populations, like those with diabetes, did not prove effective for people with schizophrenia.  More intense or tailored lifestyle programmes combined with careful management of antipsychotic medication may be needed for this group at high risk of obesity.

Citation and Funding

Holt R, Hind D, Gossage-Worrall R, Bradburn M et al. Structured lifestyle education to support weight loss for people with schizophrenia, schizoaffective disorder and first episode psychosis: the STEPWISE RCT. Health Technol Assess. 2018;22(65):1-160.

This project was funded by the National Institute for Health Research Health Technology Programme (project number 12/28/05).

Bibliography

NHS website. Schizophrenia. London: Department of Health and Social Care; updated 2016.

NHS website. Obesity: treatment. London: Department of Health and Social Care; updated 2016.

NICE. Psychosis and schizophrenia in adults: prevention and management. CG178. London: National Institute for Health and Care Excellence; 2014.

NICE. Weight management: lifestyle services for overweight or obese adults. PH53. National Institute for Health and Care Excellence; 2014.

NICE. Obesity: identification, assessment and management. CG189. London: National Institute for Health and Care Excellence; 2014.

Swaby L, Hind D, Gossage-Worrall R et al. Adherence to NICE guidance on lifestyle advice for people with schizophrenia: a survey. BJPsych Bulletin. 2016;40(5);1-8.

Naslund J, Whiteman K, McHugo G et al. Lifestyle interventions for weight loss among overweight and obese adults with serious mental illness: a systematic review and meta-analysis. Gen Hosp Psychiatry.2017;47:83-102.

Structured lifestyle education to support weight loss for people with schizophrenia, schizoaffective disorder and first episode psychosis: the STEPWISE RCT

Published on 29 November 2018

Holt R I, Hind D, Gossage-Worrall R, Bradburn M J, Saxon D, McCrone P, Morris T A, Etherington A, Shiers D, Barnard K, Swaby L, Edwardson C, Carey M E, Davies M J, Dickens C M, Doherty Y, French P, Greenwood K E, Kalidindi S, Khunti K, Laugharne R, Pendlebury J, Rathod S, Siddiqi N, Wright S, Waller G, Gaughran F, Barnett J & Northern A.

Health Technology Assessment Volume 22 Issue 65 , 2018

Background Obesity is twice as common in people with schizophrenia as in the general population. The National Institute for Health and Care Excellence guidance recommends that people with psychosis or schizophrenia, especially those taking antipsychotics, be offered a healthy eating and physical activity programme by their mental health care provider. There is insufficient evidence to inform how these lifestyle services should be commissioned. Objectives To develop a lifestyle intervention for people with first episode psychosis or schizophrenia and to evaluate its clinical effectiveness, cost-effectiveness, delivery and acceptability. Design A two-arm, analyst-blind, parallel-group, randomised controlled trial, with a 1 : 1 allocation ratio, using web-based randomisation; a mixed-methods process evaluation, including qualitative case study methods and logic modelling; and a cost–utility analysis. Setting Ten community mental health trusts in England. Participants People with first episode psychosis, schizophrenia or schizoaffective disorder. Interventions Intervention group: (1) four 2.5-hour group-based structured lifestyle self-management education sessions, 1 week apart; (2) multimodal fortnightly support contacts; (3) three 2.5-hour group booster sessions at 3-monthly intervals, post core sessions. Control group: usual care assessed through a longitudinal survey. All participants received standard written lifestyle information. Main outcome measures The primary outcome was change in weight (kg) at 12 months post randomisation. The key secondary outcomes measured at 3 and 12 months included self-reported nutrition (measured with the Dietary Instrument for Nutrition Education questionnaire), objectively measured physical activity measured by accelerometry [GENEActiv (Activinsights, Kimbolton, UK)], biomedical measures, adverse events, patient-reported outcome measures and a health economic assessment. Results The trial recruited 414 participants (intervention arm: 208 participants; usual care: 206 participants) between 10 March 2015 and 31 March 2016. A total of 341 participants (81.6%) completed the trial. A total of 412 participants were analysed. After 12 months, weight change did not differ between the groups (mean difference 0.0 kg, 95% confidence interval –1.59 to 1.67 kg; p = 0.964); physical activity, dietary intake and biochemical measures were unchanged. Glycated haemoglobin, fasting glucose and lipid profile were unchanged by the intervention. Quality of life, psychiatric symptoms and illness perception did not change during the trial. There were three deaths, but none was related to the intervention. Most adverse events were expected and related to the psychiatric illness. The process evaluation showed that the intervention was acceptable, with participants valuing the opportunity to interact with others facing similar challenges. Session feedback indicated that 87.2% of participants agreed that the sessions had met their needs. Some indicated the desire for more ongoing support. Professionals felt that the intervention was under-resourced and questioned the long-term sustainability within current NHS settings. Professionals would have preferred greater access to participants’ behaviour data to tailor the intervention better. The incremental cost-effectiveness ratio from the health-care perspective is £246,921 per quality-adjusted life-year (QALY) gained and the incremental cost-effectiveness ratio from the societal perspective is £367,543 per QALY gained. Conclusions Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 65. See the NIHR Journals Library website for further project information.

Expert commentary

The STEPWISE RCT investigators successfully implemented a challenging trial addressing a really important clinical problem: obesity in people with schizophrenia. An expensive state-of-the-art lifestyle intervention was popular amongst participants but had absolutely no effect on weight at one year or a range of secondary measures.

Negative results from well-conducted trials are gold dust. Despite being recommended by NICE, we must think beyond the adaptations of lifestyle weight management for people with schizophrenia and face the complex bio-psycho-social origins of obesity in this group, including pharmacological causes. It is a grand challenge for the field.

Peter B. Jones, Professor of Psychiatry, University of Cambridge; Honorary Consultant Psychiatrist, CPFT

The commentator declares no conflicting interests