Award Title: REalist Synthesis Of non-pharmacologicaL interVEntions for antipsychotic-induced weight gain (RESOLVE) in people living with Severe Mental Illness (SMI)
Funder: Department of Health and Social Care

Abstract: Background_x000D_
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People living with severe mental illnesses (such as schizophrenia) die up to 20 years earlier than everyone else mainly due to preventable physical illnesses such as heart disease and diabetes. One of the main treatments for illnesses like schizophrenia are medicines called ‘antipsychotics’. Unfortunately, most antipsychotics cause a lot of weight gain, causing illnesses such as diabetes._x000D_
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There are many different ways to manage and limit the weight gain caused by antipsychotics, including exercise and advice on diet. However, we don’t have a good understanding of what is likely to work for different people, and there is no clear advice for services and service users. _x000D_
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This project aims to understand which ways of helping service users to manage weight gain are most likely to work in various circumstances. From this, we will fulfil our aim of producing guidance and advice on how to manage the weight gain associated with antipsychotics._x000D_
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Planned Methods_x000D_
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We will learn lessons from what has already been written and interview people (service users/patients, family carers, and doctors, nurses, support workers and pharmacists [called clinicians]) with experience and knowledge._x000D_
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1. Literature Review _x000D_
We will use a particular method of literature review (“realist review”) that is ideally suited to making sense of complex situations. To help us to learn lessons from what has already been written, we will search widely for documents that contain information on possible ways to support people on antipsychotics to manage their weight. From the information in the documents, we will work out ‘what works for whom, when, how and why?’ This will enable us to understand why different ways of managing the weight gain are more or less likely to work. _x000D_
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2. Interviews_x000D_
These will build on and expand the findings from the literature. If the interviews identify new areas to explore, we will go back to find and review the literature in that area. We plan to interview up to 30 people with severe mental illness on antipsychotic medication, (including some from minority ethnic communities), and also their family carers.  Additionally, we will interview up to 20 clinicians. The interviews will focus on what has helped individual service users to manage their weight and any barriers identified. We will also ask them for their feedback about what we found from the literature._x000D_
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3. Analysis_x000D_
We will analyse the data that we have found in the literature and from the interviews to build an in-depth understanding of what is likely to ‘work’ to help people with severe mental illnesses to manage the weight gain caused by medication. _x000D_
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From our fresh understanding, advice and guidance for both service users and clinicians will be produced, to help them understand how they can best manage their own weight, or support others to do so._x000D_
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4. Service User Involvement_x000D_
This research will be carried out with active involvement and input from people with severe mental illness supported by the McPin Foundation (charity supporting experts by experience in research). _x000D_
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5. Dissemination (sharing what we find)_x000D_
We will share our findings with service users, clinicians and policy-makers using conferences, academic papers, newsletters and social media. Two key “end products” will provide guidance for (i) service users, and (ii) clinicians/service providers.

Lay Abstract: Research question _x000D_
How can non-pharmacological interventions manage and limit antipsychotic-induced weight gain in people living with severe mental illness (SMI)?_x000D_
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Background_x000D_
People with severe mental illnesses such as schizophrenia die on average 15 to 20 years earlier than everyone else. Two-thirds of these deaths are from preventable physical illnesses such as hypertension, cardiovascular disease and diabetes, which are worsened by weight gain. Antipsychotics, one of the main treatments, are associated with significant weight gain._x000D_
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Aim_x000D_
To use realist synthesis to develop a framework and guidance on non-pharmacological interventions to manage antipsychotic-induced weight gain in people living with SMI. _x000D_
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Methods with timelines_x000D_
Realist synthesis will be used to understand and explain how, why, for whom, and in what contexts non-pharmacological interventions help service users to manage antipsychotic-induced weight gain. Context, mechanism and outcome configurations (CMOCs) will explain how the context (situations around a person) affect mechanisms that cause outcomes. Guidance and intervention strategies will be developed as follows:_x000D_
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1. Developing initial programme theory (month 1-2)_x000D_
An initial programme theory, which sets out how and why outcomes occur within an intervention, will be developed._x000D_
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2. Developing search strategy (month 2-7) _x000D_
The initial theory will be refined using academic and grey literature. A Lived Experience Group containing service users and a Stakeholder Group containing clinicians will provide feedback and advice. The proposed initial sampling frame will be:_x000D_
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Context: people living with SMI, taking antipsychotics._x000D_
Intervention: non-pharmacological interventions. _x000D_
Mechanisms: triggered by the intervention._x000D_
Outcomes e.g. weight, quality of life, adherence, burden, economic. _x000D_
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Searching for relevant documents will continue until sufficient data is found to conclude that the refined programme theory is coherent and plausible. _x000D_
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3. Selection, appraisal, data extraction (month 3-12) _x000D_
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The RA, with support from the Project Team, will screen documents against inclusion and exclusion criteria. Text extracted from these documents will be coded as contexts, mechanisms and their relationships to outcomes in NVivo. _x000D_
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4. Primary Data Collection (month 8-16) _x000D_
Realist interviews with up to 30 service users and informal (family) carers, and 20 clinicians will gather data to support, refute or refine the programme theory. Interviews will stop when theoretical saturation is reached. _x000D_
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5. Analysis/Synthesis (month 13-24)._x000D_
Data analysis will use a realist logic to develop the programme theory. The analysis will identify practical intervention strategies to change contexts so that key mechanisms are triggered to produce desired outcomes. Guidance will be produced based on these strategies. The Lived Experience and Stakeholder Groups will provide feedback on the veracity of the findings and the feasibility of the strategies. _x000D_
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Anticipated impact and dissemination_x000D_
Producing intervention strategies and guidance for people with SMI will have direct benefit by improving physical health and quality of life. User-friendly information will be produced with the McPin Foundation for service users on strategies to manage and limit antipsychotic weight gain._x000D_
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Dissemination will be integral throughout using formats including academic papers, conferences, social media, newsletters and press releases to reach a diverse audience._x000D_
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For more information on our planned methods check our PROSPERO protocol: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=268697

Research Activity Codes: 7.3 MANAGEMENT AND DECISION MAKING
Health Categories: MENTAL HEALTH;METABOLIC AND ENDOCRINE