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.
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).
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.
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