The UK Medical Research Council’s widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.

Childhood obesity is one of the most serious public health challenges of the 21st century with far-reaching and enduring adverse consequences for health outcomes. Over 42 million children <5 years worldwide are estimated to be overweight (OW) or obese (OB), and if current trends continue, then an estimated 70 million children will be OW or OB by 2025. The purpose of this review was to focus on psychiatric, psychological, and psychosocial consequences of childhood obesity (OBy) to include a broad range of international studies. The aim was to establish what has recently changed in relation to the common psychological consequences associated with childhood OBy. A systematic search was conducted in MEDLINE, Web of Science, and the Cochrane Library for articles presenting information on the identification or prevention of psychiatric morbidity in childhood obesity. Relevant data were extracted and narratively reviewed. Findings established childhood OW/OBy was negatively associated with psychological comorbidities, such as depression, poorer perceived lower scores on health-related quality of life, emotional and behavioral disorders, and self-esteem during childhood. Evidence related to the association between attention-deficit/hyperactivity disorder (ADHD) and OBy remains unconvincing because of various findings from studies. OW children were more likely to experience multiple associated psychosocial problems than their healthy-weight peers, which may be adversely influenced by OBy stigma, teasing, and bullying. OBy stigma, teasing, and bullying are pervasive and can have serious consequences for emotional and physical health and performance. It remains unclear as to whether psychiatric disorders and psychological problems are a cause or a consequence of childhood obesity or whether common factors promote both obesity and psychiatric disturbances in susceptible children and adolescents. A cohesive and strategic approach to tackle this current obesity epidemic is necessary to combat this increasing trend which is compromising the health and well-being of the young generation and seriously impinging on resources and economic costs.

Background The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. Methods There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. Results Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six ‘core elements’ that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. Limitations The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. Conclusions This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as ‘events in systems’ that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. Future work We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. Funding This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).