Consolidated guidance for behavioral intervention pilot and feasibility studies.

BACKGROUND: In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences. METHODS: To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences. RESULTS: A total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading. CONCLUSION: We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

Exploring parents' physical activity motivation during the COVID-19 pandemic: a mixed-methods study from a self-determination theory perspective.

Background and objectives: The COVID-19 lockdowns impacted physical activity for all, but especially parents, because they had to balance home, work and leisure activities. Motivation for exercise is consistently shown to be associated with physical activity levels. Self-determination theory provides a framework through which the motivation for exercise and its social-contextual antecedents can be explored. The purpose of this study is to explore the role of motivation in determining physical activity in parents and carers of English primary school children before, during and after the COVID-19 lockdowns. Design, setting and participants: This study uses a mixed-methods design combining quantitative data and individual interviews. Participants were all parents/carers of children in year 6 (aged 10-11 years) at English primary schools in the United Kingdom. Methods: Quantitative data were collected on three occasions: between March 2017 and May 2018 (Wave 0, N = 1296), between May and December 2021 (Wave 1, N = 393) and between January and July 2022 (wave 2, N = 436). Motivation for exercise was assessed using the Behavioural Regulations in Exercise Questionnaire-2 and moderate-to-vigorous physical activity was estimated via waist-worn accelerometers. Data were analysed via regression models. Interviews with a subsample of parents (N = 43) were conducted on two occasions: between September and December 2021 and between February and July 2022. Interviews covered the impact of the pandemic on children and parents' physical activity and changes over time. This study focuses on discussions around the parents' own physical activity behaviour and their motivation. The framework method was used for analysis. Results: In separate linear regression models, intrinsic and identified regulation were associated with higher moderate-to-vigorous physical activity in waves 0 and 2. Amotivation was associated with lower moderate-to-vigorous physical activity in waves 0 and 2. In fully adjusted multivariable regression models, identified regulation was associated with a 4.9-minute increase in moderate-to-vigorous physical activity and introjected regulation was associated with a 2.3-minute decrease in moderate-to-vigorous physical activity at wave 0. Associations with moderate-to-vigorous physical activity were different in wave 2, with introjected regulation changing direction and a negative association with amotivation, although confidence intervals were wide due to smaller sample sizes. In the interviews, parents spoke of the effects that the COVID-19 lockdowns had on their motivation to be physically active in four theoretically driven themes: (1) motivation for physical activity, (2) perceived autonomy for physical activity, (3) perceived competence for physical activity and (4) perceived relatedness for physical activity. Limitations: The smaller sample sizes for waves 1 and 2 may have limited the ability to identify associations between behavioural regulations and moderate-to-vigorous physical activity post pandemic. Across all waves, parents were predominantly active, females, white and from higher socioeconomic areas and therefore may not reflect broader experiences. Conclusions and future work: Autonomous motivation, especially enjoyment and the importance for mental and physical well-being, was a key driver in keeping parents active during lockdowns and remains important for physical activity post lockdown, with introjected regulation potentially playing an increased role. Parents' interviews highlighted that while for some the lockdowns promoted autonomous motivation for exercise, others had enduring negative influences on their autonomy, competence and relatedness, which could be detrimental to their well-being. Strategies that focus on offering a range of novel activities for parents and that bring parent groups together may be effective. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131847.

The COVID-19 pandemic affected parents' ability to be active. Motivation is important for taking part in physical activity. We wanted to know how motivation for exercise had changed since before the pandemic and how it might still impact parents' physical activity. We asked groups of parents of children in year 6 (aged 10­11 years) to complete a questionnaire and wear a device that measures physical activity. One group did this before the pandemic and two groups did this after the lockdowns. We also spoke to parents two times after schools reopened. We asked about their physical activity, what they felt helped or stopped them being active and how this changed during the pandemic. Motivation plays a part in how much physical activity parents do. Enjoying activities, being active because it is part of your identity and being active due to health make parents more active. Some parents felt they were more active in the first lockdown, as they had more time, freedom and a choice of new and exciting activities, while others felt the lockdowns led to them being less active. This was due to a loss of connection with other people and feeling less confident in their physical activity. This means that it is important that parents are well-supported in their physical activity post pandemic efforts to help parents be active should focus on creating opportunities for parents to try new activities opportunities for parents to be active together might lead to more physical activity, improved connections with others and better well-being.

Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial.

The MAGENTA pragmatic parallel groups randomized controlled trial compared graded exercise therapy (GET) with activity management (AM) in treating paediatric myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). Children aged 8-17 years with mild/moderate ME/CFS and presenting to NHS specialist paediatric services were allocated at random to either individualised flexible treatment focussing on physical activity (GET, 123 participants) or on managing cognitive, school and social activity (AM, 118 participants) delivered by NHS therapists. The primary outcome was the self-reported short-form 36 physical function subscale (SF-36-PFS) after 6 months, with higher scores indicating better functioning. After 6 months, data were available for 201 (83%) participants who received a mean of 3.9 (GET) or 4.6 (AM) treatment sessions. Comparing participants with measured outcomes in their allocated groups, the mean SF-36-PFS score changed from 54.8 (standard deviation 23.7) to 55.7 (23.3) for GET and from 55.5 (23.1) to 57.7 (26.0) for AM giving an adjusted difference in means of -2.02 (95% confidence interval -7.75, 2.70). One hundred thirty-five participants completed the mean SF-36-PFS at 12 months, and whilst further improvement was observed, the difference between the study groups remained consistent with chance. The two study groups showed similar changes on most of the secondary outcome measures: Chalder Fatigue, Hospital Anxiety and Depression Scale: Depression, proportion of full-time school attended, a visual analogue pain scale, participant-rated change and accelerometer measured physical activity, whether at the 6-month or 12-month assessment. There was an isolated finding of some evidence of an improvement in anxiety in those allocated to GET, as measured by the Hospital Anxiety and Depression Scale at 6 months, with the 12-month assessment, and the Spence Children's Anxiety scale being aligned with that finding. There was weak evidence of a greater risk of deterioration with GET (27%) than with AM (17%; p = 0.069). At conventional UK cost per QALY thresholds, the probability that GET is more cost-effective than AM ranged from 18 to 21%. Whilst completion of the SF-36-PFS, Chalder Fatigue Scale and EQ-5D-Y was good at the 6-month assessment point, it was less satisfactory for other measures, and for all measures at the 12-month assessment.  Conclusion: There was no evidence that GET was more effective or cost-effective than AM in this setting, with very limited improvement in either study group evident by the 6-month or 12-month assessment points.  Trial registration: The study protocol was registered at www.isrctn.com (3rd September 2015; ISRCTN 23962803) before the start of enrolment to the initial feasibility phase.

Co-designing adult weight management services: a qualitative study exploring barriers, facilitators, and considerations for future commissioning.

BACKGROUND: Weight management services have not always benefitted everyone equally. People who live in more deprived areas, racially minoritised communities, those with complex additional needs (e.g., a physical or mental disability), and men are less likely to take part in weight management services. This can subsequently widen health inequalities. One way to counter this is to co-design services with under-served groups to better meet their needs. Using a case study approach, we explored how co-designed adult weight management services were developed, the barriers and facilitators to co-design, and the implications for future commissioning. METHODS: We selected four case studies of adult weight management services in Southwest England where co-design had been planned, representing a range of populations and settings. In each case, we recruited commissioners and providers of the services, and where possible, community members involved in co-design activities. Interviews were conducted online, audio-recorded, transcribed verbatim, and analysed using thematic analysis. RESULTS: We interviewed 18 participants (8 female; 10 male): seven commissioners, eight providers, and three community members involved in co-designing the services. The case studies used a range of co-design activities (planned and actualised), from light-touch to more in-depth approaches. In two case studies, co-design activities were planned but were not fully implemented due to organisational time or funding constraints. Co-design was viewed positively by participants as a way of creating more appropriate services and better engagement, thus potentially leading to reduced inequalities. Building relationships- with communities, individual community members, and with partner organisations- was critical for successful co-design and took time and effort. Short-term and unpredictable funding often hindered co-design efforts and could damage relationships with communities. Some commissioners raised concerns over the limited evidence for co-design, while others described having to embrace "a different way of thinking" when commissioning for co-design. CONCLUSIONS: Co-design is an increasingly popular approach to designing health in services but can be difficult to achieve within traditional funding and commissioning practices. Drawing on our case studies, we present key considerations for those wanting to co-design health services, noting the importance of building strong relationships, creating supportive organisational cultures, and developing the evidence base.

Are the Risk of Generalizability Biases Generalizable? A Meta-Epidemiological Study.

Background: Preliminary studies (e.g., pilot/feasibility studies) can result in misleading evidence that an intervention is ready to be evaluated in a large-scale trial when it is not. Risk of Generalizability Biases (RGBs, a set of external validity biases) represent study features that influence estimates of effectiveness, often inflating estimates in preliminary studies which are not replicated in larger-scale trials. While RGBs have been empirically established in interventions targeting obesity, the extent to which RGBs generalize to other health areas is unknown. Understanding the relevance of RGBs across health behavior intervention research can inform organized efforts to reduce their prevalence. Purpose: The purpose of our study was to examine whether RGBs generalize outside of obesity-related interventions. Methods: A systematic review identified health behavior interventions across four behaviors unrelated to obesity that follow a similar intervention development framework of preliminary studies informing larger-scale trials (i.e., tobacco use disorder, alcohol use disorder, interpersonal violence, and behaviors related to increased sexually transmitted infections). To be included, published interventions had to be tested in a preliminary study followed by testing in a larger trial (the two studies thus comprising a study pair). We extracted health-related outcomes and coded the presence/absence of RGBs. We used meta-regression models to estimate the impact of RGBs on the change in standardized mean difference (ΔSMD) between the preliminary study and larger trial. Results: We identified sixty-nine study pairs, of which forty-seven were eligible for inclusion in the analysis (k = 156 effects), with RGBs identified for each behavior. For pairs where the RGB was present in the preliminary study but removed in the larger trial the treatment effect decreased by an average of ΔSMD=-0.38 (range - 0.69 to -0.21). This provides evidence of larger drop in effectiveness for studies containing RGBs relative to study pairs with no RGBs present (treatment effect decreased by an average of ΔSMD =-0.24, range - 0.19 to -0.27). Conclusion: RGBs may be associated with higher effect estimates across diverse areas of health intervention research. These findings suggest commonalities shared across health behavior intervention fields may facilitate introduction of RGBs within preliminary studies, rather than RGBs being isolated to a single health behavior field.

Physical activity interventions in European primary schools: a scoping review to create a framework for the design of tailored interventions in European countries.

Introduction: Schools provide a unique environment to facilitate physical activity for children. However, many school-based physical activity interventions have not been effective. We propose a new approach, which allows schools to tailor interventions to their specific context. This scoping review aimed to identify intervention components from previous school-based physical activity interventions to form the basis of a tailored approach in a European setting. Methods: Joanna Briggs Institute guidelines for conducting scoping reviews were followed. European school-based intervention studies aimed at increasing physical activity in children aged 7-11 years published in English since 2015 were included. Databases searched were Ovid Medline, Embase, PsycINFO, Web of Science Social Sciences Citation Index, ERIC and British Education Index. Data was extracted on intervention components, context-related factors (geographical location, school size, child socioeconomic status and ethnicity), feasibility, acceptability and cost-effectiveness. A data-driven framework was developed to summarize the identified intervention components. Results: 79 articles were included, constituting 45 intervention studies. We identified 177 intervention components, which were synthesized into a framework of 60 intervention component types across 11 activity opportunities: six within the school day, three within the extended school day and two within the wider school environment. Interventions most frequently targeted physical education (21%), active and outdoor learning (16%), active breaks (15%), and school-level environmewnt (12%). Of the intervention components, 41% were delivered by school staff, 31% by the research team, and 24% by external organizations. Only 19% of intervention studies reported geographical location and only 10% reported school size. Participant ethnicity and socioeconomic information was reported by 15% and 25%, respectively. Intervention acceptability was reported in 51% of studies, feasibility in 49%, and cost effectiveness in 2%. Discussion: This review offers a first step in developing a future framework to help schools to develop context-specific, tailored interventions. However, there was a lack of reporting of contextual factors within the included studies, making it difficult to understand the role of context. Future research should seek to measure and report contextual factors, and to better understand the important aspects of context within school-based physical activity.

Study protocol for the Screen-Free Time with Friends Feasibility Trial.

BACKGROUND: Children are spending less leisure time with their friends in person and an increasing amount of time with digital screens. These changes may negatively affect children's physical and mental health. The Screen-Free Time with Friends Feasibility Trial will test the feasibility, including acceptability and compliance, of an intervention designed to reduce screen media usage and encourage physical interaction with friends during leisure time in 9-11-year-old children. METHODS: A non-randomized single-group feasibility trial will be conducted from March to October 2023 including approximately 75 children (aged 9-11 years) and 75 parents (at least 1 per child) from 3 different schools recruited from 3 different municipalities in Denmark. The Screen-Free Time with Friends intervention is a multicomponent intervention targeting families, afterschool clubs, and local communities. It has been developed using a systematic process guided by the Medical Research Council UK's framework for developing and evaluating complex interventions. With a systems perspective in mind, the intervention and implementation approach has been designed to facilitate adaptation to the specific needs of diverse local communities while maintaining the core components of the intervention. Feasibility and acceptability of the intervention will be assessed during the intervention using process evaluation inspired by the RE-AIM framework including questionnaires and interviews with the municipality project managers, research team members, local ambassadors and stakeholders, parents and school, and afterschool club personnel. In addition, participation, recruitment, retention rate, and compliance to the outcome measurements will be investigated and presented. DISCUSSION: The trial will investigate the feasibility and acceptability of the Screen-Free Time with Friends intervention, the recruitment strategy, and the planned outcome measurements. This feasibility study will investigate necessary refinements before the implementation of the intervention program in a larger cluster randomized controlled trial to evaluate its impact. CLINICALTRIALS: gov, ID: NCT05480085. Registered 29 July 2022. https://clinicaltrials.gov/ct2/show/NCT05480085?cond=Screen+free+time+with+friends&draw=2&rank=1.

The impact of the COVID-19 pandemic on the physical activity environment in English primary schools: a multi-perspective qualitative analysis.

Background: The COVID-19 lockdowns and social distancing measures, including school closures, had a major impact on children's physical activity in England, with data showing an initial reduction in activity in the short-term post-lockdown phase of the pandemic followed by a recovery on average in the medium-term post-lockdown period. The school environment is an important context for child physical activity. The purpose of this study is to understand the changes that took place to school physical activity environments once schools reopened after lockdowns. This information will improve understanding of why changes to children's physical activity have occurred over the course of the pandemic and the implications for future promotion of physical activity in schools. Methods: Interviews with parents (n = 43), school staff (n = 18) and focus groups with 10- to 11-year-old children (participant n = 92) were conducted at two time points: between September-December 2021 and February-July 2022. Interview and focus group guides covered the impact of the pandemic on child physical activity and changes to this over time. The framework method was used for analysis. Results: Three themes and three subthemes were generated: (1) the return to school; (2) over-pressured staff and environment and (3) the uneven impact of the pandemic. Theme 3 consists of three subthemes: (a) retained pandemic policies, (b) impact on physical activity culture and (c) different children need different things. Limitations and future work: Conducting this research in schools during ongoing COVID-19 disruptions was a challenge and may have limited school and participant participation, particularly school staff. The parent interview sample is predominantly female, active and of higher socioeconomic status, so the experiences of male, less active and lower socioeconomic parents are limited. This study suggests that the impact of COVID-19 on child physical activity is uneven, affecting some children more than others. Future work is therefore needed to explore the details of this potential diverging experience. Conclusion: The COVID-19 pandemic, school closures and post-lockdown school policies have impacted upon primary school physical activity environments. The post-lockdown school environment is highly pressured, impacting the extent to which schools can support and encourage child physical activity. Future research is needed to further explore the impact of post-lockdown changes on physical activity environments in schools, particularly over the longer term, as schools continue to adapt post lockdowns. Strategies required to support school physical activity environments must be context specific and sensitive to these changes, pressures and needs. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131847.

Schools are important spaces for children's physical activity. Children can be active in physical education lessons, break times, after-school clubs and travelling to school. School closures and other COVID-19 restrictions affected children's physical activity. We wanted to know how physical activity in primary schools might have changed since the pandemic. We spoke to school staff, pupils and parents two times after schools reopened. We asked about children's physical activity, and if or how this had changed over the course of the pandemic. We asked school staff about school policies around physical activity. When children went back to school, schools needed a 'recovery' approach. Children's academic, social and physical skills had been affected. For this time schools prioritised physical activity, but this was short-lived. Since then, schools have been highly pressured. They have had to 'catch up' on missed learning, staff are overloaded and some pupils are still affected by the lockdowns. Physical activity policies in schools have changed, but in many different ways. Some have kept social distancing policies; others feel their school culture has changed. Additionally, pupil ability and needs are more polarised. These factors have shaped, but are also shaped by, the high pressure in schools. Supporting changing child needs in highly pressured schools is hard for state primary schools. Changes to school physical activity policies need to be understood and evaluated. Strategies to ease pressure in schools are needed to support physical activity.

Effectiveness of the Walking in ScHools (WISH) Study, a peer-led walking intervention for adolescent girls: results of a cluster randomised controlled trial.

BACKGROUND: Most adolescent girls fail to meet current physical activity guidelines. Physical activity behaviours track from childhood into adulthood and providing adolescent girls with opportunities to be physically active may have health benefits beyond childhood. The effects of walking interventions on adult cardiometabolic health are known, however less is understood about the potential of walking to promote physical activity in adolescents. Following the Walking In ScHools (WISH) feasibility study, this definitive trial aimed to evaluate the effectiveness of a novel, low-cost, school-based walking intervention at increasing physical activity levels of adolescent girls (aged 12-14 years). METHODS: Female pupils were recruited from eighteen schools across the border region of Ireland and in Northern Ireland. In intervention schools (n = 9), girls aged 15-18 years, were trained as walk leaders, and led the younger pupils in 10-15 min walks before school, at break and lunch recess. All walks took place in school grounds and pupils were encouraged to participate in as many walks as possible each week. The primary outcome measure was accelerometer determined total physical activity (counts per minutes, cpm). RESULTS: In total, 589 pupils were recruited to the study. At baseline, pupils engaged in a median (interquartile range (IQR)) 35.7 (21.2) mins moderate-vigorous physical activity (MVPA) per day and only 12% (n = 66) of participants met physical activity guidelines (60 min MVPA per day). The intervention was delivered for a mean (standard deviation (SD)) 19.9 ± 0.97 weeks. The mean post-intervention total physical activity for the intervention group was 676 cpm and 710 cpm in the control group. Post-intervention total physical activity did not statistically differ between groups when adjusted for age, body mass index z-scores and baseline physical activity (mean difference, -33.5, 95% CI = -21.2 to 88.1; p = 0.213). CONCLUSIONS: 'Scaling-up' physical activity interventions is challenging and despite a promising feasibility study, the results of this fully powered trial suggest that in this context, the WISH intervention did not increase device measured physical activity. Since the COVID-19 pandemic, school environments have changed and although pupils enjoyed the programme, attendance at walks was low, indicating that there is a need to better understand how to implement interventions within schools. TRIAL REGISTRATION: ISRCTN; ISRCTN12847782; Registered 2nd July 2019.

Children's experiences of care on walking and cycling journeys between home and school in Healthy New Towns: Reframing active school travel.

The Healthy New Town programme in England set out to 'put health into place' by supporting the design and construction of healthy places to live, including by creating safe environments for active travel. To explore the impact of this approach, this study examined how children and their families experienced school journeys in two contrasting Healthy New Towns in England, one an affluent new town in the early stages of construction and the other more economically deprived and established. We undertook photo-elicitation and go-along interviews with 24 children aged 7-12 years and semi-structured interviews with 17 caregivers. We found that experiences of care were important for children's school travel. In the 'deprived' town, opportunities for children to care and to be cared for were enjoyed, facilitated by routes with limited traffic, pockets of 'nature', and possibilities to encounter meaningful others. For families living in a town under construction, the need to negotiate unfinished travel infrastructure, and a sense of being 'in limbo', was experienced as an absence of care by planners and developers. Interventions to promote children's active travel should consider the role of care-full planning in facilitating walking and cycling journeys.

A peer-led walking intervention for adolescent girls (the WISH study): a cluster-randomised controlled trial.

BACKGROUND: Adolescent girls in the UK and Ireland fail to meet physical activity (PA) guidelines. PA behaviours track from childhood into adulthood. The effects of walking interventions on adult health are known; however, the potential of walking to promote PA in adolescents is less known. This study evaluated the effectiveness of a novel, school-based walking intervention aimed at increasing PA levels of adolescent girls. METHODS: In this cluster-randomised controlled trial, female pupils aged 12-14 years were recruited from 18 (mixed or single-sex) schools across the border region of Ireland and Northern Ireland. Schools were randomly assigned to either the control group (usual physical activity; n=9) or the intervention group (n=9) by independent faculty staff using an online randomisation tool (randomization.com). In intervention schools, female pupils aged 15-18 years were trained as walk leaders and led the younger pupils in 10-15 min walks before school, at break, and at lunchtime. Walks were in school grounds and pupils were encouraged to join as many walks as possible. The intervention was delivered for a full school year excluding holidays (for a total of 18-21 weeks). Accelerometers measured PA, and the primary outcome was total PA (counts per minute [cpm]). Ethics approval was granted by Ulster University Research Ethics Committee and written informed consent (parent or guardian) and assent (pupils) was obtained. This study is registered with the ISRCTN Registry, 12847782. FINDINGS: The study took place from Sept 1, 2021, to May 31, 2023. In total, 589 pupils were recruited (n=286 in intervention group; n=303 in control group). Median moderate-vigorous PA (MVPA) at baseline was 36·1 min/day (IQR 23·0) for the intervention group and 35·3 min/day (19·8) for the control group. Only 37 (15%) girls in the intervention group and 29 (10%) girls in the control group met PA guidelines (60 min/day of MVPA). The mean total PA after intervention was 676 cpm (SD 18·7) for the intervention group and 710 cpm (SD 17·7) for the control group. Post-intervention total PA did not differ between groups when adjusted for age, body-mass index, z-scores, and baseline PA (mean difference -33·5, 95% CI -21·2 to 88·1; p=0·213). INTERPRETATION: Scaling up PA interventions is challenging. Despite a promising feasibility study, the results of this fully powered trial indicate that in this context, the walking programme did not increase PA. Since the COVID-19 pandemic, school environments have changed, and although pupils enjoyed the programme, attendance at walks was low. There is a need to better understand the implementation of interventions such as this within schools. FUNDING: Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN).

Comparison of children's physical activity profiles before and after COVID-19 lockdowns: A latent profile analysis.

Physical activity is important for children's health, but moderate to vigorous physical activity (MVPA) declines with age. COVID-19 lockdowns resulted in reduced MVPA and increased sedentary time among children. Characterising children's activity patterns may help identify groups who are most likely to be inactive post-lockdown. Data were combined from a pre-COVID-19 cohort study on children aged 5-6 years (Year1: n = 1299), 8-9 years (Year4: n = 1223) and 10-11 years (Year6: n = 1296) and cross-sectional post-lockdown data from a natural experiment on 10-11-year-olds in 2021 (Year6-W1: n = 393) and 2022 (Year6-W2: n = 436). The proportions of time spent in MVPA, light physical activity (LPA) and sedentary time on weekdays and weekends were derived from accelerometer data. Latent class analysis was used to identify activity profiles pre and post-lockdown, and estimate pre-COVID-19 transitions between Year4 and Year6. We identified six pre-COVID-19 activity profiles in Year6, including a new profile characterised by very low MVPA and high sedentary time (19% of children). There was substantial movement between profiles at Year4 and Year6, with 45% moving to a profile with lower MVPA. Likelihood ratio tests suggested differences in Year6 activity profiles pre and post-lockdown, with a new post-lockdown profile emerging characterised by higher LPA. The percentage of children in the least active profiles (where under 20% meet UK physical activity guidelines), rose post-lockdown, from 34% pre-COVID-19 to 50% in 2021 and 40% in 2022. We also saw gender and socioeconomic gaps widen, and increased separation between high and low physical activity levels. Children's physical activity has changed post-COVID-19, in terms of who is being active and how. The impact varies by activity profile, which is influenced by gender and socio-economic position. A greater understanding of these differences and targeting of low active groups is needed to increase both individual and population levels of physical activity.

The status of active after-school clubs among primary school children in England (UK) after the COVD-19 lockdowns: implications for policy and practice.

BACKGROUND: Children's physical activity in England is more dependent on active clubs after the COVID-19 pandemic. However, it is unclear how the COVID-19 pandemic and related cost-of-living crisis have impacted on active club participation, costs and provision. This mixed-methods natural experiment explored school-based and community-based active clubs after lockdowns, using a unique combination of data sources to highlight implications for policy and practice post-COVID-19. METHODS: Cross-sectional questionnaire data on school and community active clubs were collected from 10-11-year-old children pre-COVID-19 in 2017-18 (N = 1,296; 50 schools), in 2021 (N = 393; 23 schools), and 2022 (N = 463; 27 schools). Club participation and attendance frequency were modelled using logistic and Poisson mixed effects models, adjusted for child age, gender and household education. In 2021 and 2022, parents reported expenditure on community-based clubs and schools provided data on school-based club provision, with data summarised descriptively. Qualitative data were collected in 2021 and 2022, with one-to-one interviews with school staff (N = 18) and parents (N = 43), and twelve child focus groups (N = 92), and analysed using the framework method. RESULTS: School-based active club participation was higher in 2022 compared to pre-pandemic (50% /43%), while community-based club participation was lower (74%/80%). Children attended 0.3 fewer clubs per week. Those from lower education households were less likely to participate in both types of active clubs, and girls less likely to attend community clubs. In 2022, the median cost of community and school club sessions were £6.67 and £3.88 respectively, with 52% of school-based clubs free to parents. Schools offered an average of 3.4 active clubs per week for 10-11-year-olds in 2022, with 34% partly/wholly subsidised. Qualitative analysis highlighted the impact of the cost-of-living crisis and COVID-19 pandemic on family resources, encouraging a shift to more affordable and convenient school-based active clubs, which negatively impacted the community-based active club environment. However, many schools struggled to meet this increased demand. CONCLUSIONS: Findings emphasise the importance for policymakers to support schools to meet increased demand for clubs and community clubs to increase affordable and convenient physical activity opportunities. Targeted support is needed to prevent socioeconomic and gender inequalities.

'Including us, talking to us and creating a safe environment'-Youth patient and public involvement and the Walking In ScHools (WISH) Study: Lessons learned.

BACKGROUND: Young people have the right to be informed and consulted about decisions affecting their lives. Patient and public involvement (PPI) ensures that research is carried out 'with' or 'by' young people rather than 'to', 'about' or 'for' them. The aim of this paper is to outline how youth PPI can be embedded within a physical activity intervention, reflect on the impact of PPI and provide recommendations for future PPI in a similar context. METHODS: A Youth Advisory Group (YAG) was set up within the Walking In ScHools (WISH) Study to involve adolescent girls in the delivery, implementation and dissemination of a physical activity intervention targeted at adolescents. Schools invited pupils aged 12-14 years and 15-18 years to YAG meetings (n3, from 2019 to 2023). Participative methods were used to inform recruitment strategies and data collection methods for the WISH Study. RESULTS: Across the three YAG meetings, n51 pupils from n8 schools were involved. Pupils enjoyed the YAG meetings, felt that their feedback was valued and considered the meetings a good way to get young people involved in research. The YAG advised on specific issues and although measuring impact was not the primary aim of the YAG meetings, over the course of the study there were many examples of the impact of PPI. Recruitment targets for the WISH Study were exceeded, the attrition rate was low and pupils were engaged in data collection. CONCLUSION: Youth PPI is a developing field and there are few physical activity studies that report the PPI work undertaken. Within the WISH Study, three YAG meetings were held successfully, and the views of adolescent girls were central to the development of the study. Considering the specific issues that the YAG advised on (study recruitment, attrition and data collection), there was evidence of a positive impact of PPI. PATIENT OR PUBLIC CONTRIBUTION: Pupils from post-primary schools interested/participating in the WISH Study were invited to attend YAG meetings. YAG meetings were set up to consult adolescent girls on the delivery, implementation and dissemination of the WISH intervention.

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.

The new normal for children's physical activity and screen viewing: a multi-perspective qualitative analysis of behaviours a year after the COVID-19 lockdowns in the UK.

BACKGROUND: The COVID-19 pandemic significantly impacted children's physical activity. Recent evidence indicated children's accelerometer-measured physical activity levels have, on average, returned to near pre-pandemic levels in 2022, though sedentary behaviour remains higher. However, insufficient physical activity levels among children continues to be a critical public health issue in the UK, with only 41% meeting physical activity guidelines. This study aimed to provide in-depth analysis of how the pandemic has shaped children's physical activity patterns beyond the short-term periods following lockdowns and identify the new challenges to engaging children in physical activity. METHODS: One-to-one interviews with parents (n = 22), school staff (n = 9), and six focus groups with children aged 10-11 years (n = 45) were conducted between February and July 2022. Topics explored changes to children's physical activity and sedentary behaviour patterns, including screen-viewing, and factors influencing any changes. The framework method was used for analysis. RESULTS: Five themes were generated. Theme 1 described residual lockdown habits, including increased screen-viewing within the home, while activities outside the home continued to feel less spontaneous. Theme 2 highlighted an interrupted development of social, emotional, and physical skills among children compared to what would be expected pre-pandemic. This coincided with Theme 3 which reflected increased mental health challenges among families, creating complex barriers to children's physical activity. A new normal for child physical activity was evoked and explored in Theme 4, with greater dependence on structured and organised activities. However, Theme 5 highlighted that girls and children with lower socio-economic position may be especially at risk of decreased physical activity. CONCLUSIONS: There is a new normal for children's physical activity that is characterised by increased dependence on structured and organised physical activities, such as active clubs, and less on unstructured and spontaneous physical activities, such as physical play. While this may suit many children, girls and children from lower socio-economic households face barriers to participating in the new normal. It is important that affordable and equitable opportunities are provided to all children to prevent physical activity and health inequalities.

Natural experiments for the evaluation of place-based public health interventions: a methodology scoping review.

Introduction: Place-based public health evaluations are increasingly making use of natural experiments. This scoping review aimed to provide an overview of the design and use of natural experiment evaluations (NEEs), and an assessment of the plausibility of the as-if randomization assumption. Methods: A systematic search of three bibliographic databases (Pubmed, Web of Science and Ovid-Medline) was conducted in January 2020 to capture publications that reported a natural experiment of a place-based public health intervention or outcome. For each, study design elements were extracted. An additional evaluation of as-if randomization was conducted by 12 of this paper's authors who evaluated the same set of 20 randomly selected studies and assessed 'as-if ' randomization for each. Results: 366 NEE studies of place-based public health interventions were identified. The most commonly used NEE approach was a Difference-in-Differences study design (25%), followed by before-after studies (23%) and regression analysis studies. 42% of NEEs had likely or probable as-if randomization of exposure (the intervention), while for 25% this was implausible. An inter-rater agreement exercise indicated poor reliability of as-if randomization assignment. Only about half of NEEs reported some form of sensitivity or falsification analysis to support inferences. Conclusion: NEEs are conducted using many different designs and statistical methods and encompass various definitions of a natural experiment, while it is questionable whether all evaluations reported as natural experiments should be considered as such. The likelihood of as-if randomization should be specifically reported, and primary analyses should be supported by sensitivity analyses and/or falsification tests. Transparent reporting of NEE designs and evaluation methods will contribute to the optimum use of place-based NEEs.

Advertisement of unhealthy commodities in Bristol and South Gloucestershire and rationale for a new advertisement policy.

BACKGROUND: Bristol City Council introduced a new advertisement policy in 2021/2022 which included prohibiting the advertising of unhealthy food and drink (HFSS), alcohol, gambling and payday loans across council-owned advertising spaces. This mixed methods study is part of the BEAR study, and aimed to explore the rationale and the barriers and facilitators to implementing the policy, and describe the perceived advertising environment prior to implementation. METHODS: Semi-structured interviews were carried out with seven stakeholders involved in the design and implementation of the advertising policy. A stakeholder topic guide was developed before interviews took place to help standardise the lines of inquiry between interviewees. A resident survey was developed to collect socio-demographic data and, for the purpose of this study, information regarding observations of advertising for HFSS products, alcohol and gambling. RESULTS: Fifty-eight percent of respondents residing in Bristol and South Gloucestershire reported seeing advertisements for unhealthy commodities in the week prior to completing the survey. This was highest for HFSS products (40%). 16% of residents reported seeing HFSS product advertisements specifically appealing to children. For HFSS products in particular, younger people were more likely to report seeing adverts than older people, as were those who were from more deprived areas. An advertisement policy that restricts the advertisement of such unhealthy commodities, and in particular for HFSS products, has the potential to reduce health inequalities. This rationale directly influenced the development of the advertisement policy in Bristol. Implementation of the policy benefitted from an existing supportive environment following the 'health in all policies' initiative and a focus on reducing health inequalities across the city. CONCLUSIONS: Unhealthy product advertisements, particularly for unhealthy food and drinks, were observed more by younger people and those living in more deprived areas. Policies that specifically restrict such advertisements, therefore, have the potential to reduce health inequalities, as was the hope when this policy was developed. Future evaluation of the policy will provide evidence of any public health impact.

Conducting school-based health surveys with secondary schools in England: advice and recommendations from school staff, local authority professionals, and wider key stakeholders, a qualitative study.

BACKGROUND: Improving the health and well-being of young people is a public health priority. Schools present an ideal setting to implement strategies to improve young people's health and well-being. A key strategy involves conducting surveys to assess student health needs, inform interventions, and monitor health over time. Conducting research in schools is, however, challenging. Schools can find it difficult to participate and adhere to research processes, even when they are keen to be involved in research, because of competing priorities (e.g., attendance and educational achievement), as well as time and resource constraints. There is a lack of literature on the perspectives of school staff and other key stakeholders working in young people's health on how best to work with schools to conduct health research, and in particular, health surveys. METHODS: Participants (n = 26) included members of staff from 11 secondary schools (covering students aged 11-16 years), 5 local authority professionals, and 10 wider key stakeholders in young people's health and well-being (e.g., a school governor, a national government member), based in South West England. Participants took part in semi-structured interviews that were conducted either over the phone or via an online platform. Data were analysed using the Framework Method. RESULTS: Three main themes were identified: Recruitment and Retention, Practicalities of Data Collection in Schools, and Collaboration from Design to Dissemination. It is important to acknowledge the role of local authorities and academy trusts in the English education system, and work closely with these when conducting school-based health surveys. School staff prefer to be contacted about research via email and in the summer term, following exams. Researchers should contact a member of staff involved in student health/well-being, as well as senior leadership, during recruitment. Data collection during the start and end of the school year is undesirable. Research should be collaborative with school staff and young people, consistent with school priorities and values, and flexible and tailored to school timetables and resources. CONCLUSIONS: Overall the findings demonstrate that survey-based research methods should be school-led and tailored to each school.

Rethinking children's physical activity interventions at school: A new context-specific approach.

Physical activity is important for children's health. However, evidence suggests that many children and adults do not meet international physical activity recommendations. Current school-based interventions have had limited effect on physical activity and alternative approaches are needed. Context, which includes school setting, ethos, staff, and sociodemographic factors, is a key and largely ignored contributing factor to school-based physical activity intervention effectiveness, impacting in several interacting ways. Conceptualization: Current programs focus on tightly-constructed content that ignores the context in which the program will be delivered, thereby limiting effectiveness. We propose a move away from uniform interventions that maximize internal validity toward a flexible approach that enables schools to tailor content to their specific context. Evaluation designs: Evaluation of context-specific interventions should explicitly consider context. This is challenging in cluster randomized controlled trial designs. Thus, alternative designs such as natural experiment and stepped-wedge designs warrant further consideration. Primary outcome: A collective focus on average minutes of moderate-to-vigorous intensity physical activity may not always be the most appropriate choice. A wider range of outcomes may improve children's physical activity and health in the long-term. In this paper, we argue that greater consideration of school context is key in the design and analysis of school-based physical activity interventions and may help overcome existing limitations in the design of effective interventions and thus progress the field. While this focus on context-specific interventions and evaluation is untested, we hope to stimulate debate of the key issues to improve future physical activity intervention development and implementation.