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n-of-1 studies test hypotheses within individuals based on repeated measurement of variables within the individual over time. Intra-individual effects may differ from those found in between-participant studies. Using examples from a systematic review of n-of-1 studies in health behaviour research, this article provides a state of the art overview of the use of n-of-1 methods, organised according to key methodological considerations related to n-of-1 design and analysis, and describes future challenges and opportunities. A comprehensive search strategy (PROSPERO:CRD42014007258) was used to identify articles published between 2000 and 2016, reporting observational or interventional n-of-1 studies with health behaviour outcomes. Thirty-nine articles were identified which reported on n-of-1 observational designs and a range of n-of-1 interventional designs, including AB, ABA, ABABA, alternating treatments, n-of-1 randomised controlled trial, multiple baseline and changing criterion designs. Behaviours measured included treatment adherence, physical activity, drug/alcohol use, sleep, smoking and eating behaviour. Descriptive, visual or statistical analyses were used. We identify scope and opportunities for using n-of-1 methods to answer key questions in health behaviour research. n-of-1 methods provide the tools needed to help advance theoretical knowledge and personalise/tailor health behaviour interventions to individuals. ; This work was part of the LiveWell programme. LiveWell was supported by the Lifelong Health and Wellbeing initiative (LLHW), under Grant number G0900686. The LLHW initiative is a funding collaboration between the UK Research Councils and Health Departments. The funding partners are: Biotechnology and Biological Sciences Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Medical Research Council, Chief Scientist Office of the Scottish Government Health Directorates, National Institute for Health Research /The Department of Health, The Health and Social Care Research & Development of the Public Health Agency (Northern Ireland), and Wales Office of Research and Development for Health and Social Care, Welsh Assembly Government.

BACKGROUND: Integrating stakeholder involvement in complex health intervention design maximizes acceptability and potential effectiveness. However, there is little methodological guidance about how to integrate evidence systematically from various sources in this process. Scientific evidence derived from different approaches can be difficult to integrate and the problem is compounded when attempting to include diverse, subjective input from stakeholders. OBJECTIVE: The intent of the study was to describe and appraise a systematic, sequential approach to integrate scientific evidence, expert knowledge and experience, and stakeholder involvement in the co-design and development of a complex health intervention. The development of a Web-based lifestyle intervention for people in retirement is used as an example. METHODS: Evidence from three systematic reviews, qualitative research findings, and expert knowledge was compiled to produce evidence statements (stage 1). Face validity of these statements was assessed by key stakeholders in a co-design workshop resulting in a set of intervention principles (stage 2). These principles were assessed for face validity in a second workshop, resulting in core intervention concepts and hand-drawn prototypes (stage 3). The outputs from stages 1-3 were translated into a design brief and specification (stage 4), which guided the building of a functioning prototype, Web-based intervention (stage 5). This prototype was de-risked resulting in an optimized functioning prototype (stage 6), which was subject to iterative testing and optimization (stage 7), prior to formal pilot evaluation. RESULTS: The evidence statements (stage 1) highlighted the effectiveness of physical activity, dietary and social role interventions in retirement; the idiosyncratic nature of retirement and well-being; the value of using specific behavior change techniques including those derived from the Health Action Process Approach; and the need for signposting to local resources. The intervention principles (stage 2) included the need to facilitate self-reflection on available resources, personalization, and promotion of links between key lifestyle behaviors. The core concepts and hand-drawn prototypes (stage 3) had embedded in them the importance of time use and work exit planning, personalized goal setting, and acceptance of a Web-based intervention. The design brief detailed the features and modules required (stage 4), guiding the development of wireframes, module content and functionality, virtual mentors, and intervention branding (stage 5). Following an iterative process of intervention testing and optimization (stage 6), the final Web-based intervention prototype of LEAP (Living, Eating, Activity, and Planning in retirement) was produced (stage 7). The approach was resource intensive and required a multidisciplinary team. The design expert made an invaluable contribution throughout the process. CONCLUSIONS: Our sequential approach fills an important methodological gap in the literature, describing the stages and techniques useful in developing an evidence-based complex health intervention. The systematic and rigorous integration of scientific evidence, expert knowledge and experience, and stakeholder input has resulted in an intervention likely to be acceptable and feasible. ; This work was conducted as part of the LiveWell program (Grant Reference Number G0900686), which is funded through the Lifelong Health and Wellbeing cross-councils initiative in partnership with the following: Biotechnology and Biological Sciences Research Council; Engineering and Physical Sciences Research Council; Economic and Social Research Council; Medical Research Council; Chief Scientist Office of the Scottish Government Health Directorates; National Institute for Health Research/The Department of Health; The Health and Social Care Research & Development of the Public Health Agency (Northern Ireland); and Wales Office of Research and Development for Health and Social Care, Welsh Assembly Government. FFS is funded by Fuse, the UK Clinical Research Collaboration Centre for Translational Research in Public Health, and, at the time of this study, MW was director of Fuse. MW is also a member of the Centre for Diet and Activity Research (CEDAR). Both Fuse and CEDAR are UK Clinical Research Collaboration (UKCRC) Public Health Research Centres of Excellence. Funding from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust under the auspices of the UKCRC, is gratefully acknowledged. The views expressed in this paper are those of the authors and do not necessarily reflect those of the above named funders.

BACKGROUND: Lifestyle interventions delivered during the retirement transition might promote healthier ageing. We report a pilot randomised controlled trial (RCT) of a web-based platform (Living, Eating, Activity and Planning through retirement; LEAP) promoting healthy eating (based on a Mediterranean diet (MD)), physical activity (PA) and meaningful social roles. METHODS: A single blinded, two-arm RCT with individual allocation. Seventy-five adult regular internet users living in Northeast England, within two years of retirement, were recruited via employers and randomised in a 2:1 ratio to receive LEAP or a 'usual care' control. Intervention arm participants were provided with a pedometer to encourage self-monitoring of PA goals. Feasibility of the trial design and procedures was established by estimating recruitment and retention rates, and of LEAP from usage data. At baseline and 8-week follow-up, adherence to a MD derived from three 24-hour dietary recalls and seven-day PA by accelerometry were assessed. Healthy ageing outcomes (including measures of physiological function, physical capability, cognition, psychological and social wellbeing) were assessed and acceptability established by compliance with measurement protocols and completion rates. Thematically analysed, semi-structured, qualitative interviews assessed acceptability of the intervention, trial design, procedures and outcome measures. RESULTS: Seventy participants completed the trial; 48 (96%) participants in the intervention and 22 (88%) in the control arm. Participants had considerable scope for improvement in diet as assessed by MD score. LEAP was visited a median of 11 times (range 1-80) for a mean total time of 2.5 hours (range 5.5 min- 8.3 hours). 'Moving more', 'eating well' and 'being social' were the most visited modules. At interview, participants reported that diet and PA modules were important and acceptable within the context of healthy ageing. Participants found both trial procedures and outcome assessments acceptable. CONCLUSIONS: The trial procedures and the LEAP intervention proved feasible and acceptable. Effectiveness and cost-effectiveness of LEAP to promote healthy lifestyles warrant evaluation in a definitive RCT. TRIAL REGISTRATION: ClinicalTrials.gov NCT02136381. ; This research was undertaken by the LiveWell Programme team which is funded by the Lifelong Health and Wellbeing (LLHW) Cross-Council research initiative in partnership with the UK Health Departments. The LLHW Funding Partners are: Biotechnology and Biological Sciences Research Council (BBSRC) Engineering and Physical Sciences Research Council, Economic and Social Research Council (ESRC), Medical Research Council (MRC), Chief Scientist Office of the Scottish Government Health Directorates, National Institute for Health Research/The Department of Health, The Health and Social Care Research & Development of the Public Health Agency (Northern Ireland), and Wales Office of Research and Development for Health and Social Care, Welsh Assembly Government (Grant no. G0900686). JCM's research through the Centre for Ageing and Vitality is funded by the MRC and BBSRC. During this study, MW was partly funded and FFS was fully funded as members of Fuse, the Centre for Translational Research in Public Health, a UK Clinical Research Collaboration (UKCRC) Public Health Research Centre of Excellence. Funding for Fuse from the British Heart Foundation, Cancer Research UK, ESRC, MRC, and the National Institute for Health Research, under the auspices of the UKCRC, is gratefully acknowledged. LR and AG are supported by the National Institute for Health Research (NIHR) Newcastle Biomedical Research Centre (BRC) and Unit (BRU) based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The views expressed in this paper are those of the authors and do not necessarily represent those of the funders listed above.