Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM): protocol for a randomised feasibility trial.

INTRODUCTION: Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (PERFORM) is a research programme that seeks to develop and evaluate a comprehensive exercise-based rehabilitation intervention designed for people with multimorbidity, the presence of multiple long-term conditions (MLTCs). This paper describes the protocol for a randomised trial to assess the feasibility and acceptability of the PERFORM intervention, study design and processes. METHODS AND ANALYSIS: A multicentre, parallel two-group randomised trial with individual 2:1 allocation to the PERFORM exercise-based intervention plus usual care (intervention) or usual care alone (control). The primary outcome of this feasibility trial will be to assess whether prespecified progression criteria (recruitment, retention, intervention adherence) are met to progress to the full randomised trial. The trial will be conducted across three UK sites and 60 people with MLTCs, defined as two or more LTCs, with at least one having evidence of the beneficial effect of exercise. The PERFORM intervention comprises an 8-week (twice a week for 6 weeks and once a week for 2 weeks) supervised rehabilitation programme of personalised exercise training and self-management education delivered by trained healthcare professionals followed by two maintenance sessions. Trial participants will be recruited over a 4.5-month period, and outcomes assessed at baseline (prerandomisation) and 3 months postrandomisation and include health-related quality of life, psychological well-being, symptom burden, frailty, exercise capacity, physical activity, sleep, cognition and serious adverse events. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery and feasibility of trial processes. An economic evaluation will assess the feasibility of data collection and estimate the costs of the PERFORM intervention. ETHICS AND DISSEMINATION: The trial has been given favourable opinion by the West Midlands, Edgbaston Research Ethics Service (Ref: 23/WM/0057). Participants will be asked to give full, written consent to take part by trained researchers. Findings will be disseminated via journals, presentations and targeted communications to clinicians, commissioners, service users and patients and the public. TRIAL REGISTRATION NUMBER: ISRCTN68786622. PROTOCOL VERSION: 2.0 (16 May 2023).

Introducing the revised framework for developing and evaluating complex interventions: A challenge and a resource for nursing research.

This invited discussion paper highlights key updates in the MRC/NIHR's revised framework for the development and evaluation of complex nursing interventions and reflects on the implications for nursing research.

Reprint of: 'A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance'.

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.

Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial.

BACKGROUND: One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settings provide opportunities to deliver interventions to improve nutritional quality and physical activity to the majority of 3-4-year-olds. The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA with high acceptability in the UK. The study aims to evaluate the effectiveness and cost-effectiveness of the NAP SACC UK intervention to increase physical activity, reduce sedentary time and improve nutritional intake. METHODS: Multi-centre cluster RCT with process and economic evaluation. Participants are children aged 2 years or over, attending UK early years settings (nurseries) for ≥ 12 h/week or ≥ 15 h/week during term time and their parents, and staff at participating nurseries. The 12-month intervention involves nursery managers working with a Partner (public health practitioner) to self-assess policies and practices relating to physical activity and nutrition; nursery staff attending one physical activity and one nutrition training workshop and setting goals to be achieved within 6 months. The Partner provides support and reviews progress. Nursery staff receive a further workshop and new goals are set, with Partner support for a further 6 months. The comparator is usual practice. Up to 56 nurseries will be stratified by area and randomly allocated to intervention or comparator arm with minimisation of differences in level of deprivation. PRIMARY OUTCOMES: accelerometer-assessed mean total activity time on nursery days and average total energy (kcal) intake per eating occasion of lunch and morning/afternoon snacks consumed within nurseries. SECONDARY OUTCOMES: accelerometer-assessed mean daily minutes of moderate-to-vigorous physical activity and sedentary time per nursery day, total physical activity on nursery days compared to non-nursery days, average serving size of lunch and morning/afternoon snacks in nursery per day, average percentage of core and non-core food in lunch and morning/afternoon snacks, zBMI, proportion of children who are overweight/obese and child quality-of-life. A process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will compare costs and consequences from the perspective of the local government, nursery and parents. TRIAL REGISTRATION: ISRCTN33134697, 31/10/2019.

Digital technologies to support adolescents with depression and anxiety: review.

Depression and anxiety are common in adolescents, but most affected will not get any formal help. Digital mental health technologies (i.e. resources and interventions to support and improve mental health) are a potential way to extend the reach and increase adolescents' access to therapies, at a relatively low cost. Many young people can access the internet and mobile technologies, including in low- and middle-income countries. There has been increased interest in integrating technologies in a range of settings, especially because of the effect of the COVID-19 pandemic on adolescent mental health, at a time when services are under pressure. This clinical review gives an overview of digital technologies to support the prevention and management of depression and anxiety in adolescence. The technologies are presented in relation to their technological approaches, underlying psychological or other theories, setting, development, evaluations to date and how they might be accessed. There is also a discussion of the potential benefits, challenges and future developments in this field.

Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol.

INTRODUCTION: A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods. METHODS AND ANALYSIS: Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13-19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation. ETHICS AND DISSEMINATION: The pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. TRIAL REGISTRATION NUMBER: ISRCTN12437531.

Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial.

Background One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settings provide opportunities to deliver interventions to improve nutritional quality and physical activity to the majority of 3-4-year-olds. The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA with high acceptability in the UK. The study aims to evaluate the effectiveness and cost-effectiveness of the NAP SACC UK intervention to increase physical activity, reduce sedentary time and improve nutritional intake. Methods Multi-centre cluster RCT with process and economic evaluation. Participants are children aged 2 years or over, attending UK early years settings (nurseries) for ≥ 12 hours/week or ≥ 15 hours/week during term time and their parents, and staff at participating nurseries. The 12-month intervention involves nursery managers working with a Partner (public health practitioner) to self-assess policies and practices relating to physical activity and nutrition; nursery staff attending one physical activity and one nutrition training workshop and setting goals to be achieved within six months. The Partner provides support and reviews progress. Nursery staff receive a further workshop and new goals are set, with Partner support for a further six months. The comparator is usual practice. Up to 56 nurseries will be stratified by area and randomly allocated to intervention or comparator arm with minimisation of differences in level of deprivation. PRIMARY OUTCOMES: accelerometer-assessed mean total activity time on nursery days and average total energy (kcal) intake per eating occasion of lunch and morning/afternoon snacks consumed within nurseries. SECONDARY OUTCOMES: accelerometer-assessed mean daily minutes of moderate-to-vigorous physical activity and sedentary time per nursery day, total physical activity on nursery days compared to non-nursery days, average serving size of lunch and morning/afternoon snacks in nursery per day, average percentage of core and non-core food in lunch and morning/afternoon snacks, zBMI, proportion of children who are overweight/obese and child quality-of-life. A process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will compare costs and consequences from the perspective of the local government, nursery and parents. TRIAL REGISTRATION: ISRCTN33134697.

A qualitative study of parental strategies to enable pre-school children's outdoor and nature experiences during COVID-19 restrictions.

Outdoor and nature experiences including play have been shown to be beneficial for children's physical, cognitive, social and emotional development. Parents/carers play an important role in encouraging or impeding their child's access to the outdoor environment and participation in outdoor play. The COVID-19 pandemic and associated restrictions on free movement and social interactions placed an unprecedented pressure on families to manage the drastic change in their daily routines. This paper reports findings from two combined data sets generated in 2020 during the COVID-19 pandemic and provides a deeper understanding of the interconnected nature of how contextual factors influence parenting processes and outcomes relating to young children's outdoor and nature experiences and subsequent child health. Findings have the potential to inform the messaging of existing outdoor play policies and the content of new interventions aiming to promote the exposure of children to the natural outdoor environment.

Correction to: The prospective relationship between loneliness, life satisfaction and psychological distress before and during the COVID-19 pandemic in the UK.

[This corrects the article DOI: 10.1007/s10389-022-01719-x.].

The prospective relationship between loneliness, life satisfaction and psychological distress before and during the COVID-19 pandemic in the UK.

Aim: Mental wellbeing in the UK seems to have deteriorated significantly during the COVID-19 pandemic, with the rates of loneliness, life satisfaction and psychological distress taking longer to return to the pre-pandemic levels than elsewhere. Nevertheless, there is little knowledge about the interactions between these outcomes, or the factors that played a role in the rates of change. The current study aims to address this gap by simultaneously investigating changes in loneliness, life satisfaction and psychological distress in the UK from pre-pandemic levels to those between April and November 2020, while critically assessing the role of a range of social ecological influencing factors. Subject and Methods: Longitudinal data from Understanding Society (N=3475) were used to explore the changes in loneliness, life satisfaction and psychological distress from pre-pandemic levels (2017-2019) through November 2020, the interactions between these outcomes, and the role of individual, social, community and geographic factors in the rates of change, using multivariate latent growth curve model. Results: Loneliness, life satisfaction and psychological distress deteriorated minimally between April and November 2020, compared to the pre-pandemic levels (2017-2019), while the rate of change in each outcome influenced the rates of change in the other two. Key individual (age, gender, physical health), social (number of friends and similarity to them), and environmental (neighbourhood quality) variables influenced baseline scores and the rates of change. Conclusion: Considering significant dynamic associations between loneliness, life satisfaction and psychological distress, we argue that interventions to tackle any one of the outcomes may have beneficial effects on others, while highlighting malleable factors and individual and community-level interventions to tackle loneliness.

Recruiting residents from disadvantaged neighbourhoods for community-based health promotion and disease prevention services in Denmark-How, why and under what circumstances does an active door-to-door recruitment approach work?

Residents living in disadvantaged neighbourhoods have higher mortality and morbidity and participate less in health services than people living in more prosperous areas. Studies on how and why different approaches work for recruiting residents from disadvantaged neighbourhoods to health services are needed. Conducting face-to-face meetings with obliging health professionals (HPs) as part of an active recruitment strategy increases interest in service use, particularly among the most vulnerable residents. The services offered must be free, flexible and easily accessible for residents from disadvantaged neighbourhoods to consider their use. Residents immediately consider and 'translate' the relevance and acceptability of health services presented to them in light of their current situation, which affects their response. Individual contextual circumstances such as current health issues or difficult life circumstances, either promote or dampen their interest in using the services. This study is a realist evaluation of active face-to-face recruitment where HPs go from door-to-door to visit residents in disadvantaged neighbourhoods and offer them community-based health promotion and disease prevention services. A programme theory explicating the assumptions behind this recruitment approach was tested empirically in the present study. Eight direct observations of the active recruitment process in three different neighbourhoods and 17 realist interviews with residents were conducted. Sampling of residents was purposeful and opportunistic. Data were collected between March and August 2018. The findings support the use of active face-to-face recruitment in disadvantaged neighbourhoods to increase participation in health interventions. A broad range of health services should be presented to residents to accommodate their different needs and interests. Refusal to have services presented during active recruitment was rare, but more knowledge about these reasons for declining services is needed.

Impact of COVID-19 restrictions on preschool children's eating, activity and sleep behaviours: a qualitative study.

OBJECTIVES: In spring 2020, the first COVID-19 national lockdown placed unprecedented restrictions on the behaviour and movements of the UK population. Citizens were ordered to 'stay at home', only allowed to leave their houses to buy essential supplies, attend medical appointments or exercise once a day. We explored how lockdown and its subsequent easing changed young children's everyday activities, eating and sleep habits to gain insight into the impact for health and well-being. DESIGN: In-depth qualitative interviews; data analysed using thematic analysis. SETTING: South West and West Midlands of England. PARTICIPANTS: Twenty parents (16 mothers; 4 fathers) of preschool-age children (3-5 years) due to start school in September 2020. Forty per cent of the sample were from Black, Asian or minority ethnic backgrounds and half lived in the most deprived areas. RESULTS: Children's activity, screen time, eating and sleep routines had been disrupted. Parents reported children ate more snacks, but families also spent more time preparing meals and eating together. Most parents reported a reduction in their children's physical activity and an increase in screen time, which some linked to difficulties in getting their child to sleep. Parents sometimes expressed guilt about changes in activity, screen time and snacking over lockdown. Most felt these changes would be temporary, though others worried about re-establishing healthy routines. CONCLUSIONS: Parents reported that lockdown negatively impacted on preschool children's eating, activity and sleep routines. While some positive changes were identified, many participants described lack of routines, habits and boundaries which may have been detrimental for child health and development. Guidance and support for families during COVID-19 restrictions could be valuable to help maintain healthy activity, eating, screen time and sleeping routines to protect child health and ensure unhealthy habits are not adopted.

Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update.

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).

Interventions are actions taken to make a change, for example heart surgery, an exercise programme or a smoking ban in public. Interventions are described as complex if they comprise several stages or parts or if the context in which they are delivered is complex. A framework on how to develop and evaluate complex interventions was last published by the Medical Research Council in 2006 (Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and Evaluating Complex Interventions. London: Medical Research Council; 2006). This document describes how the framework has been updated to include advances in research methods and thinking and presents the new framework document. The updating process had four stages: (1) review of the literature to identify areas requiring update; (2) workshop of experts to discuss topics to update; (3) open consultation on a draft of the framework; and (4) writing the framework. The updated framework divides the research process into four phases: development, feasibility, evaluation and implementation. Key updates include: the definition of a complex intervention was changed to include both the content of the intervention and the context in which it is conductedaddition of systems thinking methods: an approach that considers the broader system an intervention sits withinmore emphasis on interventions that are not developed by researchers (e.g. policy changes and health services delivery)emphasis on the usefulness of evidence as the key goal of complex intervention researchidentification of six elements to be addressed throughout the research process: context; theory refinement and testing; stakeholder involvement; identification of key uncertainties; intervention refinement; and economic considerations. The updated framework is intended to help those involved in funding and designing research to consider a range of approaches, questions and methods and to choose the most appropriate. It also aims to help researchers conduct and report research that is as useful as possible to users of research.

Social Network Research contribution to evaluating process in a feasibility study of a peer-led and school-based sexual health intervention.

There is growing interest in social network-based programmes to improve health, but rigorous methods using Social Network research to evaluate the process of these interventions is less well developed. Using data from the "STis And Sexual Health" (STASH) feasibility trial of a school-based, peer-led intervention on sexual health prevention, we illustrate how network data analysis results can address key components of process evaluations for complex interventions-implementation, mechanisms of impacts, and context. STASH trained students as Peer Supporters (PS) to diffuse sexual health messages though face-to-face interactions and online Facebook (FB) groups. We applied a Multilevel Exponential Random Graph modelling approach to analyse the interdependence between offline friendship relationships and online FB ties and how these different relationships align. Our results suggest that the creation of online FB communities mirrored offline adolescent groups, demonstrating fidelity of intervention delivery. Data on informal friendship networks related to student's individual characteristics (i.e., demographics, sexual health knowledge and adherence to norms, which were included for STASH), contributed to an understanding of the social relational 'building' mechanisms that sustain tie-formation. This knowledge could assist the selection of opinion leaders, improving identification of influential peers situated in optimal network positions. This work provides a novel contribution to understanding how to integrate network research with the process evaluation of a network intervention.

Peer-to-Peer Sharing of Social Media Messages on Sexual Health in a School-Based Intervention: Opportunities and Challenges Identified in the STASH Feasibility Trial.

BACKGROUND: There is a strong interest in the use of social media to spread positive sexual health messages through social networks of young people. However, research suggests that this potential may be limited by a reluctance to be visibly associated with sexual health content on the web or social media and by the lack of trust in the veracity of peer sources. OBJECTIVE: The aim of this study was to investigate opportunities and challenges of using social media to facilitate peer-to-peer sharing of sexual health messages within the context of STASH (Sexually Transmitted Infections and Sexual Health), a secondary school-based and peer-led sexual health intervention. METHODS: Following training, and as a part of their role, student-nominated peer supporters (aged 14-16 years) invited school friends to trainer-monitored, private Facebook groups. Peer supporters posted curated educational sex and relationship content within these groups. Data came from a feasibility study of the STASH intervention in 6 UK schools. To understand student experiences of the social media component, we used data from 11 semistructured paired and group interviews with peer supporters and their friends (collectively termed students; n=42, aged 14-16 years), a web-based postintervention questionnaire administered to peer supporters (n=88), and baseline and follow-up questionnaires administered to students in the intervention year group (n=680 and n=603, respectively). We carried out a thematic analysis of qualitative data and a descriptive analysis of quantitative data. RESULTS: Message sharing by peer supporters was hindered by variable engagement with Facebook. The trainer-monitored and private Facebook groups were acceptable to student members (peer supporters and their friends) and reassuring to peer supporters but led to engagement that ran parallel to-rather than embedded in-their routine social media use. The offline context of a school-based intervention helped legitimate and augment Facebook posts; however, even where friends were receptive to STASH messages, they did not necessarily engage visibly on social media. Preferences for content design varied; however, humor, color, and text brevity were important. Preferences for social media versus offline message sharing varied. CONCLUSIONS: Invitation-only social media groups formed around peer supporters' existing friendship networks hold potential for diffusing messages in peer-based sexual health interventions. Ideally, interactive opportunities should not be limited to single social media platforms and should run alongside offline conversations. There are tensions between offering young people autonomy to engage flexibly and authentically and the need for adult oversight of activities for information accuracy and safeguarding.

An app-, web- and social support-based weight loss intervention for adults with obesity: the 'HelpMeDoIt!' feasibility randomised controlled trial.

BACKGROUND: Social support has an important role in successful weight loss. The aim of this study was to assess the feasibility and acceptability of an app-, web- and social support-based intervention in supporting adults with obesity to achieve weight loss. METHODS: The intervention and evaluation methods were tested in a feasibility randomised controlled trial. Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ≥ 30 kg/m2 were recruited and randomised 2:1 (intervention to control). The feasibility and acceptability of the intervention and trial methods were assessed against pre-specified progression criteria, via process, economic and outcome evaluation. Three primary outcomes were explored: BMI, diet and physical activity, as well as a number of secondary outcomes. The intervention group had access to the HelpMeDoIt! intervention for 12 months. This encouraged them to (i) set goals, (ii) monitor progress and (iii) harness social support by inviting 'helpers' from their existing social network. The control group received a healthy lifestyle leaflet. RESULTS: One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12 months. The intervention and trial methods were feasible and acceptable. Participants and helpers were generally positive. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it. Interview data indicated that HelpMeDoIt! promoted social support from existing social networks to support weight loss. This support was often given outside of the app.Outcomes were compared using linear regression models, with randomised group, the baseline measurement of the outcome, age and gender as predictor variables. These analyses were exploratory and underpowered to detect effects. However, all pre-specified primary outcome effects (BMI, diet and physical activity) had wide confidence intervals and were therefore consistent with clinically relevant benefits. Objective physical activity measures perhaps showed most potential (daily step count (p = 0.098; 1187 steps [- 180, 2555])) and sedentary time (p = 0.022; - 60.8 min [- 110.5, - 11.0]). However, these outcomes were poorly completed. CONCLUSIONS: The study demonstrated that a novel social support intervention involving support from participants' close social networks, delivered via app and website, has potential to promote weight loss and is feasible and acceptable. TRIAL REGISTRATION: ISRCTN, ISRCTN85615983. Registered 25 September 2014.

Tackling reporting issues and variation in behavioural weight management interventions: Design and piloting of the standardized reporting of adult behavioural weight management interventions to aid evaluation (STAR-LITE) template.

In the United Kingdom, the National Institute for Health and Care Excellence make recommendations to guide the local-level selection and implementation of adult behavioural weight management interventions (BWMIs) which lack specificity. The reporting of BWMIs is generally poorly detailed, resulting in difficulties when comparing effectiveness, quality and appropriateness for participants. This non-standardized reporting makes meta-analysis of intervention data impossible, resulting in vague guidance based on weak evidence, reinforcing the urgent need for consistency and detail within BWMI description. STAR-LITE - a 4-section, 119-item standardized adult BWMI reporting template - was developed and tested using a two-phase process. After initial design, the template was piloted using adult behavioural weight management RCTs and currently implemented UK BWMI mapping information to further refine the template and examine current reporting and variance. Overall, reporting quality of weight management RCTs was poor, and large variance across different components of real-world BWMIs was observed. Non-specific guidance and wide variation in adult BWMIs are likely linked to inadequate RCT reporting quality and the inability to perform reliable comparisons of data. Future use of STAR-LITE would facilitate the consistent, detailed reporting of adult BWMIs, supporting their evaluation and comparison, to ultimately inform effective policy and improve weight management practice.

Correction to: Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial.

After publication of our article [1] we have been notified that two of the author names have been mistakenly removed from the authorship list: Colin R. Howie and Nicholas D. Clement.

Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial.

BACKGROUND: Patients' pre-operative health and physical function is known to influence their post-operative outcomes. In patients with knee osteoarthritis, pharmacological and non-pharmacological options are often not optimised prior to joint replacement. This results in some patients undergoing surgery when they are not as fit as they could be. The aim of this study is to assess the feasibility and acceptability of a pre-operative package of non-operative care versus standard care prior to joint replacement. METHODS/DESIGN: This is a multicentre, randomised controlled feasibility trial of patients undergoing primary total knee replacement for osteoarthritis. Sixty patients will be recruited and randomised (2:1) to intervention or standard care arms. Data will be collected at baseline (before the start of the intervention), around the end of the intervention period and a minimum of 90 days after the planned date of surgery. Adherence will be reviewed each week during the intervention period (by telephone or in person). Participants will be randomised to a pre-operative package of non-operative care or standard care. The non-operative care will consist of (1) a weight-loss programme, (2) a set of exercises, (3) provision of advice on analgesia use and (4) provision of insoles. The intervention will be started as soon as possible after patients have been added to the waiting list for joint replacement surgery to take advantage of the incentive for behavioural change that this will create. The primary outcomes of this study are feasibility outcomes which will indicate whether the intervention and study protocol is feasible and acceptable and whether a full-scale effectiveness trial is warranted. The following will be measured and used to inform study feasibility: rate of recruitment, rate of retention at 90-day follow-up review after planned surgery date, and adherence to the intervention estimated through review questionnaires and weight change (for those receiving the weight-loss aspect of intervention). In addition the following information will be assessed qualitatively: analysis of qualitative interviews exploring acceptability, feasibility, adherence and possible barriers to implementing the intervention, and acceptability of the different outcome measures. DISCUSSION: The aims of the study specifically relate to testing the feasibility and acceptability of the proposed effectiveness trial intervention and the feasibility of the trial methods. This study forms the important first step in developing and assessing whether the intervention has the potential to be assessed in a future fully powered effectiveness trial. The findings will also be used to refine the design of the effectiveness trial. TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN96684272. Registered on 18 April 2018.