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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

The Eating Disorders In weight-related Therapy (EDIT) Collaboration brings together data from randomised controlled trials of behavioural weight management interventions to identify individual participant risk factors and intervention strategies that contribute to eating disorder risk. We present a protocol for a systematic review and individual participant data (IPD) meta-analysis which aims to identify participants at risk of developing eating disorders, or related symptoms, during or after weight management interventions conducted in adolescents or adults with overweight or obesity. We systematically searched four databases up to March 2022 and clinical trials registries to May 2022 to identify randomised controlled trials of weight management interventions conducted in adolescents or adults with overweight or obesity that measured eating disorder risk at pre- and post-intervention or follow-up. Authors from eligible trials have been invited to share their deidentified IPD. Two IPD meta-analyses will be conducted. The first IPD meta-analysis aims to examine participant level factors associated with a change in eating disorder scores during and following a weight management intervention. To do this we will examine baseline variables that predict change in eating disorder risk within intervention arms. The second IPD meta-analysis aims to assess whether there are participant level factors that predict whether participation in an intervention is more or less likely than no intervention to lead to a change in eating disorder risk. To do this, we will examine if there are differences in predictors of eating disorder risk between intervention and no-treatment control arms. The primary outcome will be a standardised mean difference in global eating disorder score from baseline to immediately post-intervention and at 6- and 12-months follow-up. Identifying participant level risk factors predicting eating disorder risk will inform screening and monitoring protocols to allow early identification and intervention for those at risk.

IntroductionA digital programme, MoodHwb, was co-designed with young people experiencing or at high risk of depression, parents/carers, and professionals, to provide support for young people with their mood and wellbeing. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. The present 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 analysisInitially, this study will refine MoodHwb with the involvement of young people, including in a pre-trial acceptability phase. This will be followed by a multi-centre 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, primary 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 two months post-randomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, wellbeing and depression and anxiety symptoms measured at two months post-randomisation.Ethics and disseminationThe pre-trial 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 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 numberISRCTN12437531.Strengths and limitations of this studyMoodHwb was co-designed with young people with lived experience or at high risk of depression, parents/carers, and practitioners.MoodHwb is bilingual, personalised according to user needs and preferences, and has been developed in line with evidence-based approaches to support young people with depressive symptoms and their parents/carers, friends, and practitioners.Multiple methods will be used to collect data in a range of settings for the trial, including validated questionnaires, semi-structured interviews, a focus group, and Web/app usage monitoring.As this is a feasibility study, we will not be able to determine the effectiveness of MoodHwb; however, the findings will inform the design of a definitive effectiveness trial.Participants will not be blind to treatment allocation as this is not possible with an intervention of this kind.

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.

BackgroundDuring COVID-19 restrictions in England in spring 2020, early years settings for young children were closed to all but a small percentage of families, social contact was limited and play areas in parks were closed. Concerns were raised about the impact of these restrictions on young children’s emotional wellbeing. The aim of this study was to explore parents’ perceptions of young children’s emotional wellbeing during these COVID-19 restrictions.MethodsWe interviewed 20 parents of children 3-4 years due to begin school in England in September 2020. Interviews were conducted via telephone (n=18) and video call (n=2), audio-recorded and transcribed verbatim. Interviews focused on childcare arrangements, children’s behaviour and transition to school. A sample of transcripts were coded line-by-line to create a coding framework, which was subsequently applied to the remaining transcripts. Coded data were then analysed using a nurture lens to develop themes and further understanding.ResultsParticipants were predominantly mothers (n=16), White British (n=10), and educated to degree level (n=13), with half the sample living in the highest deprivation quintile in England (n=10). Five were single parents. Three themes developed from nurturing principles were identified: creating age-appropriate explanations; understanding children’s behaviour; concerns about school transition. Parents reported that their children’s emotional wellbeing was impacted and described attempts to support their young children whilst looking ahead to their transition to primary school.ConclusionsThis study is one of the first to examine in-depth perceptions of COVID-19 restrictions on young children’s emotional wellbeing. The longer-term impacts are not yet understood. Although young children may be unable to understand in detail what the virus is, they undoubtedly experience the disruption it brings to their lives. The wellbeing of families and children needs to be nurtured as they recover from the effects of the pandemic to allow them to thrive.

Background With most mental health problems established during childhood/adolescence, young people must be a key focus of public mental health approaches. Despite the range of factors known to influence mental health, evidence for effective interventions is lacking for this age group. This study aimed to define priorities for future public health intervention-focused research to support youth mental health by engaging with transdisciplinary stakeholder groups. Methods Our coproduction approach involved priority-setting workshops with young people, researchers, practitioners and policy-makers. Each workshop focused on three thematic areas: social connections and relationships; schools and other education settings; and key groups at greater risk of mental ill-health, specifically LGBTQ+ and care-experienced young people. Workshop outputs were synthesized to define research priorities. Results This paper presents the research priorities that were defined through the priority-setting workshops, and our reflections on the coproduction approach to guide future similar activities undertaken by others. Ten priorities for youth public mental health research were defined, covering the following areas: building supportive relationships; whole system approaches; social media; support at times of transition; improving links between different services; development and training for those who support young people; staff mental health; engaging with families; awareness of and access to services; and out-of-school and community settings. Conclusions These research priorities can inform future intervention development to support youth public mental health. Our transdisciplinary approach means the identified research priorities are likely to be relevant to young people’s experiences and needs, and to fit with the needs of those working in practice and policy to support young people.

Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p p p Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

In light of unsatisfactory educational outcomes in lower and higher education in Texas, the practice of instituting progressively lower academic standards should be reconsidered. The continual stream of students who graduate and demonstrate low proficiency in writing skills in the marketplace reflects poorly on the academic integrity of their colleges and universities. It is inherent to the job of educators to be gatekeepers, ensuring the academic proficiency of students who pass their courses. If the issue of academic rigor, which is necessary for high-level learning, fails to be a priority of educational leaders, it is doubtful whether the current stream of students and dollars will continue to flow to higher education institutions. If the line of rigor between respected colleges and so-called degree paper mills begins to blur, educators may wake up to a culture that is not willing to traverse traditional educational pathways which are no more than a shadow of the intellectual fortresses of the past. Rather than continuing to lower educational standards, educational researchers and legislators should return to the standards that made American schools and colleges the destination of choice for many in the world: academic tasks that are challenging, testing methods that are strict and valid, and degrees that employers trust to represent graduates with critical and advanced skills.

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.

BackgroundYoung people report higher levels of unsafe sex and have higher rates of sexually transmitted infections than any other age group. Schools are well placed to facilitate early intervention, but more effective approaches are required. Peer-led approaches can augment school-based education, but often fail to capitalise on mechanisms of social influence. The potential of using social media in sexual health has not been tested in school settings.ObjectivesFinalise the design of the Sexually Transmitted infections And Sexual Health (STASH) intervention; assess the recruitment and retention of peer supporters, and acceptability to participants and stakeholders; assess the fidelity and reach, in addition to the barriers to and facilitators of, implementation; refine programme theory; understand the potential of social media; determine design parameters for a future randomised controlled trial, including economic evaluation; and establish whether or not progression criteria were met.DesignThis was a feasibility study comprising intervention development and refinement of the STASH pilot and non-randomised feasibility trial in six schools. Control data were provided by students in the year above the intervention group.SettingSecondary schools in Scotland.ParticipantsStudents aged 14–16 years, teachers and intervention delivery partners.InterventionsThe STASH intervention was adapted from A Stop Smoking In Schools Trial (ASSIST) (an effective peer-led smoking intervention). Based on diffusion of innovation theory, the STASH study involves peer nomination to identify the most influential students, with the aim of recruiting and training 15% of the year group as peer supporters. The peer supporters deliver sexual health messages to friends in their year group via conversations and use of Facebook (www.facebook.com; Facebook, Inc., Menlo Park, CA, USA) to share varied content from a curated set of web-based resources. Peer supporters are given support themselves via follow-up sessions and via trainer membership of Facebook groups.Main outcome measuresThe primary outcome was whether or not progression criteria were met in relation to intervention acceptability and feasibility. The study also piloted indicative primary outcomes for a full-scale evaluation.Data sourcesPeer supporter questionnaire; observations of activities; interviews with trainers, teachers, peer supporters and students; monitoring log of peer supporter activities (including on Facebook and meeting attendance); questionnaire to control year group (baseline characteristics, social networks, mediators and sexual health outcomes); baseline and follow-up questionnaire (approximately 6 months later) for intervention year group.ResultsA total of 104 students were trained as peer supporters (just over half of those nominated for the role by their peers). Role retention was very high (97%). Of 611 students completing the follow-up questionnaire, 58% reported exposure to STASH study activities. Intervention acceptability was high among students and stakeholders. Activities were delivered with good fidelity. The peer supporters were active, representative of their year group and well connected within their social network. Carefully managed social media use by peer supporters augmented conversations. A primary outcome of ‘always safer sex’ was identified, measured as no sex or always condom use for vaginal or anal sex in the last 6 months. The intervention cost £42 per student. Six progression criteria were met. A seventh criterion (regarding uptake of role by peer supporters) was not.LimitationsSmall feasibility study that cannot comment on effectiveness.ConclusionsThe STASH intervention is feasible and acceptable within the context of Scottish secondary schools. The results support continuation to a full-scale evaluation.Future workSmall-scale improvements to the intervention, refinement to programme theory and funding sought for full-scale evaluation.Trial registrationCurrent Controlled Trials ISRCTN97369178.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 8, No. 15. See the NIHR Journals Library website for further project information.

Background\ud There is increasing interest in digital technologies to help improve children and young people’s mental health, and the evidence for the effectiveness for these approaches is rising. However, there is concern regarding levels of user engagement, uptake and adherence. Key guidance regarding digital health interventions stress the importance of early user input in the development, evaluation and implementation of technologies to help ensure they are engaging, feasible, acceptable and potentially effective. Co‐design is a process of active involvement of stakeholders, requiring a change from the traditional approaches to intervention development. However, there is a lack of literature to inform the co‐design of digital technologies to help child and adolescent mental health.\ud \ud Methods\ud We reviewed the literature and practice in the co‐design of digital mental health technologies with children and young people. We searched Medline, PsycInfo and Web of Science databases, guidelines, reviews and reference lists, contacted key authors for relevant studies, and extracted key themes on aspects of co‐design relevant to practice. We supplemented this with case studies and methods reported by researchers working in the field.\ud \ud Results\ud We identified 25 original articles and 30 digital mental health technologies that were designed/developed with children and young people. The themes identified were as follows: principles of co‐design (including potential stakeholders and stages of involvement), methods of involving and engaging the range of users, co‐designing the prototype and the challenges of co‐design.\ud \ud Conclusions\ud Co‐design involves all relevant stakeholders throughout the life and research cycle of the programme. This review helps to inform practitioners and researchers interested in the development of digital health technologies for children and young people. Future work in this field will need to consider the changing face of technology, methods of engaging with the diversity in the user group, and the evaluation of the co‐design process and its impact on the technology.

SUMMARY 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.

COVID-19 has been associated with worse outcomes in people living with obesity and has altered how people can engage with weight management. However, the impact of risk perceptions and changes to daily life on weight loss has not been explored. This study aimed to examine how COVID-19 and perception of risk interacted with weight loss attempts in adults participating in a behavioural weight management programme. Forty-eight participants completed a semi-structured interview exploring the impact of COVID-19 on their weight management experience. Interviews were completed via telephone and analysed using a thematic approach. Reaction to perceived risk varied, but most participants reported the knowledge of increased risk promoted anxiety and avoidance behaviours. Despite this, many reported it as a motivating factor for weight loss. Restrictions both helped (e.g., reduced temptation) and hindered their weight loss (e.g., less support). However, there was consensus that the changes to everyday life meant participants had more time to engage with and take control of their weight loss. To the authors' knowledge, this is the first study to explore the impact of COVID-19 on participation in a weight management programme started during the pandemic in the United Kingdom. Restrictions had varying impacts on participant's weight loss. How risk is perceived and reported to participants is an important factor influencing engagement with weight management. The framing of health information needs to be considered carefully to encourage engagement with weight management to mitigate risk. Additionally, the impact of restrictions and personal well-being are key considerations for weight management programmes.

High rates of mental ill-health in postgraduate researchers (PGRs) represent a significant barrier to life satisfaction and academic success. Nevertheless, there is little knowledge about the extent and origins of mental health problems of PGRs in the UK. The current study addresses this gap by investigating the prevalence and provenance of anxiety, depression, sleep problems, subjective mental wellbeing, and suicide behaviours of PGRs in the UK. An online survey (N = 479) was used to measure the mental health outcomes and assess their relationships with demographic, trait and academic variables, policy, and social support. We found a high prevalence of mental ill-health and low levels of wellbeing in the current sample. Factors associated with poorer outcomes were female and non-binary gender, non-heterosexual identity, maladaptive perfectionism, workaholism and being in the 5th year of study or above. Resilience, adaptive perfectionism, higher levels of social support and positive evaluations of progress and preparation, departmental climate, and supervisory relationship were associated with more positive outcomes. The current findings contribute new knowledge about the prevalence of mental health symptoms in PGRs in the UK, implying that institutional efforts to improve PGR wellbeing should include strategies to promote equality, diversity, resilience, integration, social support, and work-life balance of PGRs.

Introduction: Recent research has revealed high rates of mental health issues in postgraduate researchers (PGRs). Mental ill-health is a barrier to life satisfaction and academic success. More knowledge is necessary to understand the extent and origins of mental health problems of PGRs in the UK. Aims: To assess the prevalence of anxiety, depression, sleep problems, subjective mental wellbeing, and suicide behaviours of PGRs in the UK, as well as to explore the factors that underpin these outcomes.Methods: An online survey (N=479) was used to measure the mental health outcomes, and assess the influence of demographic, trait and academic variables, and social support. Results: In this sample the prevalence of mental ill-health was high, while wellbeing was lower than in the general population. Female, non-binary and non-heterosexual PGRs had poorer mental health than their male and/or heterosexual counterparts. Researchers in the field of Arts had higher levels of wellbeing, while those in the 5th year of study or above were at a higher risk of suicidal behaviours. Resilience, adaptive perfectionism, social support and positive evaluations of progress and preparation, departmental climate, and supervisory relationship were associated with positive outcomes, while maladaptive perfectionism and workaholism were linked to the negative ones. Resilience and workaholism were the only variables that played a role in all mental health outcomes.Conclusions: The current paper contributes new knowledge about the PGR wellbeing, the prevalence of mental health symptoms, and some of the factors that shape them. Our findings imply that institutional efforts to improve PGR mental health and wellbeing should include a variety of strategies to promote equality, diversity, resilience, integration and work-life balance of PGRs.

Introduction Adolescence is a key developmental period for the onset of mental illness. Healthy rhythms of sleep and activity are critical for mental wellbeing in young people. Yet getting healthy diurnal rhythms becomes challenging for teens, due to developmental changes and multiple social and technological factors modifiable risk factor. We addressed this relationship in a feasibility study by investigating sleep-wake patterns of teenagers and their mental health, wellbeing, and cognitive performance. Methods 9 schools of the SHINE network in Scotland took part in the study. Pupils wore an actigraph for 3 weeks, allowing the collection of objective rest-activity data. During the 3 weeks, they filled in -twice a day- a brief ecological momentary assessment with mood questions on their mobile phone (EMAapp). At the beginning and at the end of this period, participants also completed a digital online survey with further questions about mental health, sleep, and wellbeing (pre- and post- questionnaire) and they performed a cognitive assessment (6 subtests) on the online platform TestMyBrain (TMB). Results The feasibility study included two data acquisitions. In Winter (Feb-March 2021), during the lockdown, 8 schools took part for a total of 60 students, whereas, in Summer (May-June 2021), 3 schools took part for a total of 15 students. Preliminary feasibility results are summarised in the table 1 below. Discussion Overall, relatively good participation, especially during the lockdown. Compliance decreased from the pre- to the post- questionnaire session and within TMB itself. Only 2 people fully completed the study. 11% of the pupils had problem with the EMA app, as reflected in the average low entries. Regarding the actigraph, it was generally well tolerated (a few pupils complained having a rash at the end). Further actigraphy analyses are ongoing. Funding MRC Engagement Award for Adolescent Mental Health.

Complex interventions are commonly used in the health and social care services, public health practice, and other areas of social and economic policy that have consequences for health. Such interventions are delivered and evaluated at different levels, from individual to societal. Examples include a new surgical procedure, the redesign of a health care programme, and a change in welfare policy. The UK Medical Research Council (MRC) published a framework for researchers and research funders on developing and evaluating complex interventions in 2000 and revised guidance in 2006.[1] Although these documents continue to be widely used and are now accompanied by a range of more detailed guidance on specific aspects of the research process,[2–5] there have been important conceptual, methodological and theoretical developments since 2006. These developments have been addressed in a new framework commissioned by the National Institute of Health Research (NIHR) and the MRC.[6] The framework aims to help researchers work with other stakeholders to identify the key questions about complex interventions, and to design and conduct research with a diversity of perspectives and appropriate choice of methods., The work was funded by the NIHR (Department of Health and Social Care 73514) and Medical Research Council (MRC). Additional time on the study was funded by grants from the MRC for Kathryn Skivington (MC_UU_12017/11, MC_UU_00022/3), Lynsay Matthews, Sharon Anne Simpson, Laurence Moore (MC_UU_12017/14, MC_UU_00022/1), Peter Craig (MC_UU_12017/15, MC_UU_00022/2), Martin White (MC_UU_12015/6 and MC_UU_00006/7). Additional time on the study was also funded by grants from the Chief Scientist Office of the Scottish Government Health Directorates for Kathryn Skivington (SPHSU11 and SPHSU18), Lynsay Matthews, Sharon Anne Simpson and Laurence Moore (SPHSU14 and SPHSU16), and Peter Craig (SPHSU13 and SPHSU15). Kathryn Skivington and Sharon Anne Simpson were also supported by an MRC Strategic Award (MC_PC_13027). JBl received funding from NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol and by the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures - MR/K025643/1). MP is funded in part as director of the NIHR’s Public Health Policy Research Unit.

BackgroundIn spring 2020, the COVID-19 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. This qualitative study 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 wellbeing.MethodsIn summer 2020 we interviewed 20 parents of children due to start school in September 2020 (aged 3-5 years) by phone or video call to explore their experiences of lockdown and its easing. We recruited participants through nurseries and local Facebook community groups in the South West and West Midlands of England. Half the sample were from Black, Asian or Minority Ethnic backgrounds and half lived in the most deprived quintile. We analysed interviews using thematic analysis.ResultsChildren’s activity, screen time, eating, and sleep routines had some level of disruption. Parents reported children ate more snacks during lockdown, but also spent more time preparing meals and eating as a family. 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 with no lasting impact, though others worried about re-establishing healthy routines.ConclusionsThe spring COVID-19 lockdown negatively impacted on pre-school children’s eating, activity and sleep routines. While some positive changes were reported, there were wide-spread reports of lack of routines, habits and boundaries which, at least in the short-term, were likely to have been detrimental for child health and development. Guidance and support for families during times of COVID-19 restrictions could be valuable to help them maintain healthy activity, eating, screen-time and sleeping routines to protect child health and ensure unhealthy habits are not adopted.

Purpose Mindfulness-based interventions (MBIs) are effective treatments for stress, anxiety, and depression in PwMS. However, low adherence and high attrition may limit effectiveness. Qualitative research can provide important insights into MBI acceptability, accessibility, and implementation. This systematic review and meta-aggregation evaluated qualitative research findings on the use of MBIs for PwMS. Methods Systematic searches were undertaken in six major electronic databases. Studies using qualitative or mixed methods were included. Two reviewers screened, data extracted, and critically appraised studies. Meta-aggregation was performed following the Joanna Briggs Institute approach, extracting findings, developing categories, and synthesizing findings. Results Six eligible papers, including 136 PwMS were included in meta-aggregation. 136 findings were extracted, grouped into 17 categories, with four synthesized findings: (1) "accessing mindfulness," (2) "a sense of belonging," (3) "experiencing mindfulness," and (4) "making mindfulness more relevant and sustainable for PwMS." Conclusions MBIs for PwMS need to take into consideration disability which can limit accessibility. Online MBIs (synchronous and asynchronous) appear acceptable alternatives to traditional face-to-face courses. However, PwMS benefit from shared (mindful) experiencing and highlight MBI instructors as crucial in helping them understand and practice mindfulness. Involving PwMS in design, delivery, and iterative refinement would make MBIs more relevant to those taking part.IMPLICATIONS FOR REHABILITATIONBoth face-to-face and online Mindfulness-based interventions (MBIs) appear acceptable to PwMS and, ideally, people should be offered a choice in training modality.PwMS derive benefit from undertaking MBIs with their peers, where a sense of camaraderie and belonging develop through shared (mindful) experiences.Instructors delivering MBIs for PwMS should be knowledgeable about the condition; participants describe how the instructor has a key role in helping them practice mindfulness effectively in the context of unpleasant experiences associated with MS.MBIs tailored for PwMS should include a pre-course orientation session, clearly articulate how mindfulness practices can help with MS, provide well-organized course materials in large font size, and deliver individual mindfulness practices flexibly depending on participant need.

BackgroundThe 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.MethodsThere 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.ResultsKey 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.LimitationsThe 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.ConclusionsThis 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 workWe 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.FundingThis project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).

The aim of the current study was to assess associations between loneliness and personal wellbeing among young people. Framed by social ecological theory, the study examined demographic, social, and community factors associated with personal wellbeing and, critically, identified malleable moderators of the relationship between loneliness and personal wellbeing that could be targeted in intervention efforts.We used cross-sectional, secondary data from 965 young people (aged 16-24) from the Community Life Survey in England. Loneliness was measured using a single-item direct measure; personal wellbeing was measured through a composite measure containing items relating to happiness, life satisfaction and a sense that life is worthwhile (α = 0.88). Regression techniques were used to assess direct associations between individual, social, and community factors and personal wellbeing, and identify factors that moderate the association between loneliness and personal wellbeing. Loneliness was negatively associated with wellbeing. Frequency of chatting with neighbours and having people to provide help moderated the relationship between loneliness and personal wellbeing. Young people who were full-time students or reported good physical health had higher personal wellbeing, while being a carer was predictive of decreased wellbeing. Having people to count on was the only social variable significantly associated with personal wellbeing, while all community factors were found to be strongly associated with increased wellbeing. Our results advance the current literature by identifying that supportive social relationships and close community ties are important for reducing the negative impact of loneliness on youth wellbeing. Intervention efforts to improve wellbeing could benefit from specifically targeting these aspects of young people’s social and community lives, while acknowledging individual vulnerabilities, such as poor physical health.

BackgroundDuring COVID-19 restrictions in England in spring 2020, early years settings for young children were closed to all but a small percentage of families, social contact was limited and play areas in parks were closed. Concerns were raised about the impact of these restrictions on young children’s emotional wellbeing. The aim of this study was to explore parents’ perceptions of young children’s emotional wellbeing during these COVID-19 restrictions.MethodsWe interviewed 20 parents of children 3-4 years due to begin school in England in September 2020. Interviews were conducted via telephone (n=18) and video call (n=2), audio-recorded and transcribed verbatim. Interviews focused on childcare arrangements, children’s behaviour and transition to school. A sample of transcripts were coded line-by-line to create a coding framework, which was subsequently applied to the remaining transcripts. Coded data were then analysed using a nurture lens to develop themes and further understanding.ResultsParticipants were predominantly mothers (n=16), White British (n=10), and educated to degree level (n=13), with half the sample living in the highest deprivation quintile in England (n=10). Five were single parents. Three themes developed from nurturing concepts were identified: creating age-appropriate explanations; understanding children’s behaviour; concerns about school transition. Parents recognised their children’s emotional wellbeing was impacted but attempted to support their young children whilst looking ahead to their transition to primary school.ConclusionsThis study is one of the first to examine in-depth the impact of COVID-19 restrictions on young children’s emotional wellbeing. The longer-term impacts are not yet understood. Although young children may be unable to understand in detail what the virus is, they undoubtedly experience the disruption it brings to their lives. The wellbeing of families and children needs to be nurtured as they recover from the effects of the pandemic to allow them to thrive.Key messagesCOVID-19 restrictions are predicted to have a negative impact on young children.We interviewed parents of children in England due to begin primary school to understand their experiences of COVID-19 restrictions.Nurture concepts helped us understand the challenges families faced.Key themes identified were: creating age-appropriate explanations; understanding children’s behaviour; and concerns about school transition.We suggest a nurturing approach to recovery to best support children and their families.

Background Effective sex education is the key to good sexual health. Peer-led approaches can augment teacher-delivered sex education, but many fail to capitalise on mechanisms of social influence. We assessed the feasibility of a novel intervention (STASH) in which students (aged 14–16) nominated as influential by their peers were recruited and trained as Peer Supporters (PS). Over a 5–10-week period, they spread positive sexual health messages to friends in their year group, both in-person and via social media, and were supported to do so via weekly trainer-facilitated meetings. The aims of the study were to assess the feasibility of STASH (acceptability, fidelity and reach), to test and refine the programme theory and to establish whether the study met pre-set progression criteria for continuation to larger-scale evaluation. Methods The overall design was a non-randomised feasibility study of the STASH intervention in 6 schools in Scotland. Baseline (n=680) and follow-up questionnaires (approx. 6 months later; n=603) were administered to the intervention year group. The control group (students in year above) completed the follow-up questionnaire only (n=696), 1 year before the intervention group. The PS (n=88) completed a brief web survey about their experience of the role; researchers interviewed participants in key roles (PS (n=20); PS friends (n=22); teachers (n=8); trainers (n=3)) and observed 20 intervention activities. Activity evaluation forms and project monitoring data also contributed information. We performed descriptive quantitative analysis and thematic qualitative analysis. Results The PS role was acceptable; on average across schools >50% of students nominated as influential by their friends, signed up and were trained (n=104). This equated to 13% of the year group. Trained PS rarely dropped out (97% completion rate) and 85% said they liked the role. Fidelity was good (all bar one trainer-led activity carried out; PS were active). The intervention had good reach; PS were reasonably well connected and perceived as ‘a good mix’ and 58% of students reported exposure to STASH. Hypothesised pre-conditions, contextual influences and mechanisms of change for the intervention were largely confirmed. All bar one of the progression criteria was met. Conclusion The weight of evidence supports continuation to full-scale evaluation. Trial registration Current controlled trials ISRCTN97369178

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.

Background In the past decades, behavioral medicine has attained global recognition. Due to its global reach, a critical need has emerged to consider whether the original definition of behavioral medicine is still valid, comprehensive, and inclusive, and to reconsider the main tasks and goals of the International Society of Behavioral Medicine (ISBM), as the umbrella organization in the field. The purpose of the present study was to (i) update the definition and scope of behavioral medicine and its defining characteristics; and (ii) develop a proposal on ISBM’s main tasks and goals. Method Our study used the Delphi method. A core group prepared a discussion paper. An international Delphi panel rated questions and provided comments. The panel intended to reach an a priori defined level of consensus (i.e., 70%). Results The international panel reached consensus on an updated definition and scope of behavioral medicine as a field of research and practice that builds on collaboration among multiple disciplines. These disciplines are concerned with development and application of behavioral and biomedical evidence across the disease continuum in clinical and public health domains. Consensus was reached on a proposal for ISBM’s main tasks and goals focused on supporting communication and collaboration across disciplines and participating organizations; stimulating research, education, and practice; and supporting individuals and organizations in the field. Conclusion The consensus on definition and scope of behavioral medicine and ISBM’s tasks and goals provides a foundational step toward achieving these goals.

Objectives Incarcerated young men commonly experience problems with impulsivity and emotional dysregulation. Mindfulnesstraining could help but the evidence is limited. This study developed and piloted an adapted mindfulness-based intervention forthis group (n = 48).Methods Feasibility of recruitment, retention, and data collection were assessed, and the effectiveness of mindfulness trainingmeasured using validated questionnaires. Twenty-five qualitative interviews were conducted to explore experiences of thecourse, and barriers and facilitators to taking part.Results The findings indicated that recruitment and retention to mindfulness training groups was a challenge despite tryingvarious adaptive strategies to improve interest, relevance, and acceptability. Quantitative data collection was feasible at baselineand post-course. There were significant improvements following training in impulsivity (effect size [ES] 0.72, 95% CI 0.32–1.11,p = 0.001), mental wellbeing (ES 0.50; 95% CI 0.18–0.80; p = 0.003), inner resilience (comprehensibility ES 0.35; 95% CI −0.02–0.68; p = 0.03), and mindfulness (ES 0.32; 95% CI 0.03–0.60; p = 0.03). The majority (70%) of participants reportedfinding the course uncomfortable or disconcerting at first but if they chose to remain, this changed as they began to experiencebenefit. The body scan and breathing techniques were reported as being most helpful. Positive experiences included better sleep,less stress, feeling more in control, and improved relationships.Conclusions Developing and delivering mindfulness training for incarcerated young men is feasible and may be beneficial, butrecruitment and retention may limit reach. Further studies are required that include a control group.

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.

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

Background Treatment and prevention guidelines highlight the key role of health information and evidence-based psychosocial interventions for adolescent depression. Digital health technologies and psychoeducational interventions have been recommended to help engage young people and to provide accurate health information, enhance self-management skills, and promote social support. However, few digital psychoeducational interventions for adolescent depression have been robustly developed and evaluated in line with research guidance. Objective We aimed to evaluate the feasibility, acceptability, and potential impact of a theory-informed, co-designed digital intervention program, MoodHwb. Methods We used a mixed methods (quantitative and qualitative) approach to evaluate the program and the assessment process. Adolescents with or at elevated risk of depression and their parents and carers were recruited from mental health services, school counselors and nurses, and participants from a previous study. They completed a range of questionnaires before and after the program (related to the feasibility and acceptability of the program and evaluation process, and changes in mood, knowledge, attitudes, and behavior), and their Web usage was monitored. A subsample was also interviewed. A focus group was conducted with professionals from health, education, social, and youth services and charities. Interview and focus group transcripts were analyzed using thematic analysis with NVivo 10 (QSR International Pty Ltd). Results A total of 44 young people and 31 parents or carers were recruited, of which 36 (82%) young people and 21 (68%) parents or carers completed follow-up questionnaires. In all, 19 young people and 12 parents or carers were interviewed. Overall, 13 professionals from a range of disciplines participated in the focus group. The key themes from the interviews and groups related to the design features, sections and content, and integration and context of the program in the young person’s life. Overall, the participants found the intervention engaging, clear, user-friendly, and comprehensive, and stated that it could be integrated into existing services. Young people found the “Self help” section and “Mood monitor” particularly helpful. The findings provided initial support for the intervention program theory, for example, depression literacy improved after using the intervention (difference in mean literacy score: 1.7, 95% CI 0.8 to 2.6; P Conclusions Findings from this early stage evaluation suggest that MoodHwb and the assessment process were feasible and acceptable, and that the intervention has the potential to be helpful for young people, families and carers as an early intervention program in health, education, social, and youth services and charities. A randomized controlled trial is needed to further evaluate the digital program.

BACKGROUND There is strong interest in the use of social media to spread positive sexual health messages through young people’s social networks. However, research suggests this potential may be limited by a reluctance to be visibly associated with sexual health content online, and by lack of trust in the veracity of peer sources. OBJECTIVE To investigate opportunities and challenges of using social media to facilitate peer-to-peer sharing of sexual health messages within the context of a secondary school-based and peer-led sexual health intervention (STASH; Sexually Transmitted infections And Sexual Health). METHODS Following training, and as part of their role, student-nominated peer supporters (aged 14-16) invited school friends to trainer-monitored, private Facebook groups. Peer supporters posted curated educational sex and relationships content within these groups. Data come 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 semi-structured paired and group interviews with peer supporters and their friends (collectively, ‘students’; n=42; aged 14-16); a web-based post-intervention questionnaire to peer supporters (n=88); and baseline and follow-up questionnaires to students in the intervention year group (n=680 and 603 respectively). We carried out thematic analysis of qualitative data and 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 the Facebook posts; but even where friends were receptive to STASH messages, they did not necessarily engage visibly. Preferences for content design varied, but humor, color and text brevity were important. Preferences for online 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. CLINICALTRIAL Isrctn97369178

Children and adolescents commonly suffer from sleep and circadian rhythm disturbances, which may contribute to poorer mental health and wellbeing during this critical developmental phase. Many studies however rely on self-reported sleep measures. This study assessed whether accelerometry data collection was feasible within the school setting as a method for investigating the extent of sleep and circadian disruption, and associations with subjective wellbeing, in Scotland. Fourteen days of wrist-worn accelerometry data were collected from 69 pupils, aged 10-14 years. Objective measures of sleep timing, sleep duration and circadian rest-activity patterns were derived. Questionnaires assessed subjective sleep timing, depressive symptoms, and experiences of wearing the accelerometer. Pupils slept on average less than 8 hours per night, failing to meet standard age-specific recommendations. Sleep timing was later and duration longer on weekends compared to weekdays (B = 0.87, 95% confidence interval (CI) 0.70, 1.04; B = 0.49, 95% CI 0.29, 0.69), indicating social jetlag. Lower daytime activity was correlated with higher depressive symptoms (r = -0.84, p = 0.008). Compared to primary school pupils, secondary pupils had shorter sleep window duration and lower circadian relative amplitude. Over half of participants reported some discomfort/inconvenience wearing the accelerometer. These data highlight that inadequate sleep is prevalent in this sample of schoolchildren. Future, larger scale investigations will examine in more detail the associations between sleep, circadian function and physical activity with mental health and wellbeing.

Background Finding solutions to rising levels of obesity continues to be a major public health focus. Social support has an important role in successful weight loss, and digital interventions can reach a large proportion of the population at low cost. Objective To develop and assess the feasibility and acceptability of an application (app), web- and social support-based intervention in supporting adults with obesity to achieve weight loss goals. Design Stage 1 – intervention development phase involved three focus groups (n = 10) with users, and think-aloud interviews and field testing with another group (n = 28). Stage 2 – the intervention and evaluation methods were explored in a feasibility randomised controlled trial with economic and process evaluation. Setting Greater Glasgow and Clyde, UK. Participants Adults with a body mass index of ≥ 30kg/m2 who owned a smartphone and were interested in losing weight were randomised 2 : 1 (intervention : control) and followed up at 12 months. Recruitment took place in April–October 2016. Interventions The intervention group had access to HelpMeDoIt! for 12 months. This encouraged them to (1) set goals, (2) monitor progress and (3) harness social support by inviting ‘helpers’ from their existing social network. The control group received a healthy lifestyle leaflet. Main outcome measures Data from stage 1 informed the intervention design. Key measures in stage 2 assessed the feasibility and acceptability of the intervention and trial methods against prespecified progression criteria. Three primary outcomes were explored: body mass index, diet and physical activity. Secondary outcomes included weight, waist and hip circumference, social support, self-efficacy, motivation, mental health, health-related quality of life, NHS resource use, participant-borne costs and intervention costs. Qualitative interviews with participants (n = 26) and helpers (n = 9) explored the feasibility and acceptability of the trial methods and intervention. Results Stage 1 produced (1) a website that provided evidence-based information for lifestyle change and harnessing social support, and (2) an app that facilitated goal-setting, self-monitoring and supportive interaction between participants and their helper(s). Progression criteria were met, demonstrating that the intervention and trial methods were feasible and acceptable. A total of 109 participants (intervention, n = 73; control, n = 36) were recruited, with 84 participants (77%: intervention, 71%; control, 89%) followed up at 12 months. Data were successfully collected for most outcome measures (≥ 82% completion). Participants and helpers were generally positive, although helper engagement with the app was low. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it twice or more, 28 helpers enrolled via the app, and 19 (36%) participants interacted with their helper(s) via the app. Interview data indicated that HelpMeDoIt! prompted support from helpers that often occurred without the helpers using the app. Limitations Early technical problems meant that some participants and helpers had difficulty accessing the app. Ethical constraints meant that we were unable to contact helpers directly for interview. Conclusions The HelpMeDoIt! study demonstrated that a weight loss intervention delivered via an app and a website is feasible and acceptable. Progression criteria were met, supporting further evaluation of the intervention. Future work To further explore (1) the motivation and engagement of helpers, (2) the programme theory and (3) the effectiveness and cost-effectiveness of the intervention. Trial registration Current Controlled Trials ISRCTN85615983. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 3. See the NIHR Journals Library website for further project information.

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.

To determine the relationship between psychological stress with cognitive outcomes in a multi-centre longitudinal study of people with amnestic mild cognitive impairment (aMCI) we assessed three parameters of psychological stress (Recent Life Changes Questionnaire (RLCQ); the Perceived Stress Scale (PSS) and salivary cortisol) and their relationship with rates of cognitive decline over an 18 month follow up period and conversion to dementia over a 5.5 year period. In 133 aMCI and 68 cognitively intact participants the PSS score was higher in the aMCI compared with control group but neither the RLCQ scores nor salivary cortisol measures were different between groups. In the aMCI group the RLCQ and the PSS showed no significant association with cognitive function at baseline, cognitive decline or with conversion rates to dementia but high salivary cortisol levels were associated with RLCQ scores and poorer cognitive function at baseline and lower rates of cognitive decline. No relationship was found between salivary cortisol levels and conversion rate to dementia. We conclude that psychological stress as measured by the RLCQ or PSS was not associated with adverse cognitive outcomes in an aMCI population and hypothesise that this may reflect diminished cortisol production to psychological stress as the disease progresses.

Background: Behavioural weight management interventions in research studies and clinical practice differ in length, advice, frequency of meetings, staff and cost. Few real-world programmes have published patient outcomes and those that have used different ways of reporting information, making it impossible to compare interventions and develop the evidence base. To address this issue, we have developed a core outcome set for behavioural weight management intervention programmes for adults with overweight and obesity. Methods: Outcomes were identified via systematic review of the literature. A representative expert group was formed comprising people with experience of adult weight management services. An online Delphi process was employed to reach consensus as to which outcomes should be measured and reported, and which definitions/instruments should be utilised. Results: The expert group identified 8 core outcomes and 12 core processes for reporting by weight management services. 11 outcomes and 5 processes were identified as optional. The most appropriate definitions/instruments for measuring each outcome/process were also agreed. Conclusions: Our core outcome set will ensure consistency of reporting. This will allow behavioural weight management interventions to be compared, revealing which interventions work best for which members of the population and helping inform development of adult behavioural weight management interventions.