Changing the food environment in secondary school canteens to promote healthy dietary choices: a qualitative study with school caterers.

BACKGROUND: Typical adolescent diets do not meet current dietary recommendations. There is a need to address these dietary patterns to reduce the risk of obesity and other diet-related diseases. Schools provide an opportune setting to do so, as students consume a substantial proportion of their daily dietary intake whilst at school. There is a developing evidence base on the use of choice architecture (food choice cues) to promote healthy eating in school contexts. It is necessary to understand the acceptability and feasibility of implementing such interventions. We aimed to explore these factors from the perspectives of secondary school caterers. METHODS: We conducted qualitative interviews with caterers from secondary schools across the West Midlands, UK and national/regional catering representatives. A semi-structured topic guide and visual aid were used to guide interviews. Interviews were recorded and transcribed. Framework analysis was conducted in NVivo v12. RESULTS: Twelve participants took part. Seven themes were identified and grouped into three categories: Acceptability (Suitability; Salient cues; Student engagement), Barriers (Catering decision drivers; Limits of influence), and Enablers (Perceived role; Opportunities). Caterers considered healthy food cues to be suited to adolescents as they require minimal reflective motivation. Salient cues included enhancing the placement, presentation and portability of healthy items, improving the dining environment and focusing pricing/incentive strategies on increased quantity. Student engagement was considered important. Some catering decision drivers conflicted with healthy food cues, and many felt that their role in healthy eating was limited due to the overwhelming influence of external food environments, adolescent resistance, and features of the secondary school canteen setting e.g. short duration of lunchtime, lack of space. However, caterers appeared motivated to implement healthy food cues and identified key opportunities for implementation, including integration into whole-school approaches to healthy eating. CONCLUSIONS: Interventions using healthy food cues appeared acceptable to secondary school caterers, key potential implementers of these strategies. Future interventions could incorporate strategies relating to placement, presentation and pricing to prompt healthy selections, and actions to engage the student body and improve the dining environment. Evaluations should consider potential impacts upon food purchasing, consumption and waste to address caterers' concerns about these issues.

The Erasmus+ EUMOVE project-a school-based promotion of healthy lifestyles to prevent obesity in European children and adolescents.

The aim of this study was to describe the goals, activities, and methods of EUMOVE project in developing a set of resources targeting both primary and secondary schools that allow the entire educational community to promote healthy lifestyles (HL). The EUMOVE project is an Erasmus+ program based in the Creating Active Schools (CAS) framework. The project lasted 3 years and was developed by 14 academic and non-governmental institutions from Spain, Portugal, France, Italy, and the UK. EUMOVE was divided into three phases. In the first phase, several work packages were carried out aimed to ensure the coordination/management of the project activities. In the second phase, seven educational resources strengthened by rigorous scientific research were developed to promote HL from schools. During the last phase, all the resources were disseminated through scientific seminars, workshops with families and teachers, and the online promotion by the non-governmental institutions of each country. The EUMOVE project developed and promoted a smartphone APP, video/activity repository of physically active lessons, active break virtual platform, learning units, and parent/teachers/school-leaders' guidelines to promote physical activity, active commuting, active school playgrounds, healthy diet, and sleep habits. To our knowledge, EUMOVE is the first European project to provide a set of practical tools based on scientific evidence to help schools or future school-wide interventions implement a paradigm shift based on the CAS framework for the promotion of HL. Future research will need to investigate the implementation, effectiveness, and scalability of this proposal.

How Does the University Environment Relate to Student's Physical Activity Patterns in Ireland.

BACKGROUND: Identifying factors related to physical activity in university students can aid the development of health promotion interventions, but there is limited research regarding the influence of university environments. This study examined the relationship between level of provision for university environments that aim to promote physical activity and self-reported physical activity patterns of students. METHODS: An environmental audit tool was completed by universities (n = 28) on the island of Ireland to acquire information about physical activity opportunities, resources, and supports offered. Students (N = 6951; 50.7% male; 21.51 [5.55] y) completed an online survey, providing responses about their active transport and recreational physical activity behaviors. Binary logistic regressions were used to examine the associations between environmental factors that support physical activity and clustered physical activity patterns, while controlling for gender, age, and university size. RESULTS: Universities with a high provision for organizational structures and internal partnerships, indoor facilities, and sport clubs increase the odds of their students having more active physical activity patterns. Increased provision of investment and personnel was seen to have a mixed relationship with students' physical activity engagement, highlighting the need to understand where resources are needed and not just increase them. CONCLUSIONS: It is important for universities to have adequate organizational structures with internal partnerships to understand how resources can be maximized to support physical activity engagement across the whole student population. University campuses hold the potential for increasing student engagement in physical activity, and these findings can help inform campus-wide initiatives that foster active student populations for improving overall long-term health.

'Walk Buds': A walking intervention to increase physical activity, physical fitness, and emotional wellbeing, in 9-13 year old children with intellectual disabilities. Results of a clustered randomised feasibility trial.

BACKGROUND: Children with intellectual disability are less physically active and more sedentary than typically developing peers. To date no studies have tested the feasibility of a school-based walking intervention for children with Intellectual Disability. METHOD: A clustered randomised controlled trial (cRCT), with an embedded process evaluation, was used to test the feasibility of a school-based walking intervention. Eight schools (n = 161 pupils aged 9-13 years) were randomised into either an intervention arm or an 'exercise as usual' arm. Measures included physical activity, physical fitness and emotional wellbeing. Baseline and 3-month follow-up data were collected. RESULTS: The 'Walk Buds' intervention was found to be acceptable to teaching staff and pupils, with an uptake rate of the walking sessions offered of 84%. CONCLUSION: A number of challenges were experienced, relating to the COVID-19 pandemic, and difficulties collecting accelerometer data. Barriers, facilitators and required changes identified through the mixed methods process evaluation are discussed.

Correction: Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/55039.].

Is Scotland Walking in the Right Direction? A Cross-Sectional Analysis of Trends in Walking by Socioeconomic Status.

BACKGROUND: Walking is a key target behavior for promoting population health. This paper charts the 30-year history of walking policy in Scotland. We assess whether population walking levels among adults in Scotland have changed in recent years and identify the characteristics of those least likely to report any walking. METHODS: We pooled 9 years (2012-2019 and 2021) of data from adult (≥16 y) respondents of the Scottish Health Survey (n = 41,470). The outcomes of interest were the percentage reporting (1) any walking and (2) any walking with an average pace that is of at least moderate intensity. We also investigated the contribution of walking to total nonoccupational moderate to vigorous physical activity. We used linear and logistic regressions to test linear trends over time and to identify inequalities by age, sex, and the Scottish Index of Multiple Deprivation quintile. RESULTS: There was an increase in all measures of walking over the period 2012-2021; for example, the percentage reporting any walking increased by 7 percentage points (81.4%-88.4%). Inequalities still exist by age, sex, and the Scottish Index of Multiple Deprivation but have not grown over time. Inequalities by sex and age are most pronounced in the least affluent Scottish Index of Multiple Deprivation quintiles; less affluent older women are least likely to report any walking. CONCLUSIONS: Scotland appears to be walking in the right direction. Surveillance data support a positive trend after decades of policy and promotion efforts. The policies do not appear to be exacerbating existing inequalities, but narrowing them will require more concentrated efforts.

Computer-Facilitated Screening and Brief Intervention for Alcohol Use Risk in Adolescent Patients of Pediatric Primary Care Offices: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Alcohol and other substance use disorders usually begin with substance use in adolescence. Pediatric primary care offices, where most adolescents receive health care, are a promising venue for early identification of substance use and for brief intervention to prevent associated problems and the development of substance use disorder. OBJECTIVE: This study tests the effects of a computer-facilitated screening and brief intervention (cSBI) system (the CRAFFT [Car, Relax, Alone, Forget, Family/Friends, Trouble] Interactive System [CRAFFT-IS]) on heavy episodic drinking, riding with a driver who is substance impaired, or driving while substance impaired among adolescents aged 14 to 17 years presenting for a well visit at pediatric primary care practices. METHODS: We are conducting a cluster randomized controlled trial of the CRAFFT-IS versus usual care and recruiting up to 40 primary care clinicians at up to 20 pediatric primary care practices within the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings network. Clinicians are randomized 1:1 within each practice to implement the CRAFFT-IS or usual care with a target sample size of 1300 adolescent patients aged 14 to 17 years. At study start, intervention clinicians complete web-based modules, trainer-led live sessions, and mock sessions to establish baseline competency with intervention counseling. Adolescents receive mailed recruitment materials that invite adolescents to complete an eligibility survey. Eligible and interested adolescents provide informed assent (parental permission requirement has been waived). Before their visit, enrolled adolescents seeing intervention clinicians complete a self-administered web-based CRAFFT screening questionnaire and view brief psychoeducational content illustrating substance use-associated health risks. During the visit, intervention clinicians access a computerized summary of the patient's screening results and a tailored counseling script to deliver a motivational interviewing-based brief intervention. All participants complete previsit, postvisit, and 12-month follow-up study assessments. Primary outcomes include past 90-day heavy episodic drinking and riding with a driver who is substance impaired at 3-, 6-, 9-, and 12-month follow-ups. Multiple logistic regression modeling with generalized estimating equations and mixed effects modeling will be used in outcomes analyses. Exploratory aims include examining other substance use outcomes (eg, cannabis and nicotine vaping), potential mediators of intervention effect (eg, self-efficacy not to drink), and effect moderation by baseline risk level and sociodemographic characteristics. RESULTS: The AAP Institutional Review Board approved this study. The first practice and clinicians were enrolled in August 2022; as of July 2023, a total of 6 practices (23 clinicians) had enrolled. Recruitment is expected to continue until late 2024 or early 2025. Data collection will be completed in 2025 or 2026. CONCLUSIONS: Findings from this study will inform the promotion of high-quality screening and brief intervention efforts in pediatric primary care with the aim of reducing alcohol-related morbidity and mortality during adolescence and beyond. TRIAL REGISTRATION: ClinicalTrials.gov NCT04450966; https://www.clinicaltrials.gov/study/NCT04450966. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55039.

The International Olympic Committee framework on fairness, inclusion and nondiscrimination on the basis of gender identity and sex variations does not protect fairness for female athletes.

The International Olympic Committee (IOC) recently published a framework on fairness, inclusion, and nondiscrimination on the basis of gender identity and sex variations. Although we appreciate the IOC's recognition of the role of sports science and medicine in policy development, we disagree with the assertion that the IOC framework is consistent with existing scientific and medical evidence and question its recommendations for implementation. Testosterone exposure during male development results in physical differences between male and female bodies; this process underpins male athletic advantage in muscle mass, strength and power, and endurance and aerobic capacity. The IOC's "no presumption of advantage" principle disregards this reality. Studies show that transgender women (male-born individuals who identify as women) with suppressed testosterone retain muscle mass, strength, and other physical advantages compared to females; male performance advantage cannot be eliminated with testosterone suppression. The IOC's concept of "meaningful competition" is flawed because fairness of category does not hinge on closely matched performances. The female category ensures fair competition for female athletes by excluding male advantages. Case-by-case testing for transgender women may lead to stigmatization and cannot be robustly managed in practice. We argue that eligibility criteria for female competition must consider male development rather than relying on current testosterone levels. Female athletes should be recognized as the key stakeholders in the consultation and decision-making processes. We urge the IOC to reevaluate the recommendations of their Framework to include a comprehensive understanding of the biological advantages of male development to ensure fairness and safety in female sports.

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.

Results from Ireland North and South's 2022 report card on physical activity for children and adolescents.

Background: The Ireland North and South Report Card on Physical Activity (PA) for Children and Adolescents aims to monitor progress in PA participation across a range of internationally established indicators. Methods: Data were collated for 11 indicators and graded following the harmonised Active Healthy Kids Global Alliance report card process. Six representative studies (sample size range n = 898 to n = 15,557) were primarily used in the grading, with many indicators supplemented with additional studies and reports. Data collected since the implementation of COVID-19 public health measures in March 2020 were excluded. Results: Grades were awarded as follows: 'Overall physical activity', C-; 'Organised Sport and Physical Activity', C; 'Active Play', INC; 'Sedentary Behaviours', C-; 'Physical Fitness', INC; 'Family and Peers', D+; 'School', C-; 'Physical Education', D; 'Community and Environment', B+ and 'Government', B. Separate grades were awarded for disability as follows; 'Overall physical activity', F; 'Organised Sport and Physical Activity', D; 'Sedentary Behaviours', C-; 'Family and Peers', C; 'School', C- and 'Government', B. 'Active Play', 'Physical Fitness', 'Physical Education' and 'Community and Environment' were all graded INC for disability. Since the last report card in 2016, four grades remained the same, three increased ('Overall physical activity', 'School' and 'Physical Education') and two ('Family and Peers,' and 'Government') were awarded grades for the first time. Conclusion: Grades specific to children and adolescents with disability were generally lower for each indicator. While small improvements have been shown across a few indicators, PA levels remain low across many indicators for children and adolescents.

Risk-based approach to setting sterile filtration microbial bioburden limits - Focus on biotech-derived products.

Holistic concepts should be applied that reduce risks prior to final bioburden testing and sterile filtration, based on enhanced process and product attribute understanding, which could be key to successful bioburden risk management. Key findings of this paper include.

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).

'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.

Brief bouts of device-measured intermittent lifestyle physical activity and its association with major adverse cardiovascular events and mortality in people who do not exercise: a prospective cohort study.

BACKGROUND: Guidelines emphasise the health benefits of bouts of physical activity of any duration. However, the associations of intermittent lifestyle physical activity accumulated through non-exercise with mortality and major adverse cardiovascular events (MACE) remain unclear. We aimed to examine the associations of bouts of moderate-to-vigorous intermittent lifestyle physical activity (MV-ILPA) and the proportion of vigorous activity contributing within these bouts with mortality and MACE. METHODS: In this prospective cohort study, we used data from the UK Biobank on adults who do not exercise (ie, those who did not report leisure-time exercise) who had wrist-worn accelerometry data available. Participants were followed up until Nov 30, 2022, with the outcome of interest of all-cause mortality obtained through linkage with NHS Digital of England and Wales, and the NHS Central Register and National Records of Scotland, and MACE obtained from inpatient hospitalisation data provided by the Hospital Episode Statistics for England, the Patient Episode Database for Wales, and the Scottish Morbidity Record for Scotland. MV-ILPA bouts were derived using a two-level Random Forest classifier and grouped as short (<1 min), medium (1 to <3 min; 3 to <5 min), and long (5 to <10 min). We further examined the dose-response relationship of the proportion of vigorous physical activity contributing to the MV-ILPA bout. FINDINGS: Between June 1, 2013, and Dec 23, 2015, 103 684 Biobank participants wore an accelerometer on their wrist. 25 241 adults (mean age 61·8 years [SD 7·6]), of whom 14 178 (56·2%) were women, were included in our analysis of all-cause mortality. During a mean follow-up duration of 7·9 years (SD 0·9), 824 MACE and 1111 deaths occurred. Compared with bouts of less than 1 min, mortality risk was lower for bouts of 1 min to less than 3 min (hazard ratio [HR] 0·66 [0·53-0·81]), 3 min to less than 5 min (HR 0·56 [0·46-0·69]), and 5 to less than 10 min (HR 0·48 [0·39-0·59]). Similarly, compared with bouts of less than 1 min, risk of MACE was lower for bouts of 1 min to less than 3 min (HR 0·71 [0·54-0·93]), 3 min to less than 5 min (0·62 [0·48-0·81]), and 5 min to less than 10 min (0·59 [0·46-0·76]). Short bouts (<1 min) were associated with lower MACE risk only when bouts were comprised of at least 15% vigorous activity. INTERPRETATION: Intermittent non-exercise physical activity was associated with lower mortality and MACE. Our results support the promotion of short intermittent bouts of non-exercise physical activity of moderate-to-vigorous intensity to improve longevity and cardiovascular health among adults who do not habitually exercise in their leisure time. FUNDING: Australian National Health, Medical Research Council, and Wellcome Trust.

Digital Health Implementation Strategies Coproduced With Adults With Acquired Brain Injury, Their Close Others, and Clinicians: Mixed Methods Study With Collaborative Autoethnography and Network Analysis.

BACKGROUND: Acquired brain injuries (ABIs), such as stroke and traumatic brain injury, commonly cause cognitive-communication disorders, in which underlying cognitive difficulties also impair communication. As communication is an exchange with others, close others such as family and friends also experience the impact of cognitive-communication impairment. It is therefore an internationally recommended best practice for speech-language pathologists to provide communication support to both people with ABI and the people who communicate with them. Current research also identifies a need for neurorehabilitation professionals to support digital communication, such as social media use, after ABI. However, with >135 million people worldwide affected by ABI, alternate and supplementary service delivery models are needed to meet these communication needs. The "Social Brain Toolkit" is a novel suite of 3 interventions to deliver communication rehabilitation via the internet. However, digital health implementation is complex, and minimal guidance exists for ABI. OBJECTIVE: This study aimed to support the implementation of the Social Brain Toolkit by coproducing implementation knowledge with people with ABI, people who communicate with people with ABI, clinicians, and leaders in digital health implementation. METHODS: A maximum variation sample (N=35) of individuals with living experience of ABI, close others, clinicians, and digital health implementation leaders participated in an explanatory sequential mixed methods design. Stakeholders quantitatively prioritized 4 of the 7 theoretical domains of the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework as being the most important for Social Brain Toolkit implementation. Qualitative interview and focus group data collection focused on these 4 domains. Data were deductively analyzed against the NASSS framework with stakeholder coauthors to determine implementation considerations and strategies. A collaborative autoethnography of the research was conducted. Interrelationships between considerations and strategies were identified through a post hoc network analysis. RESULTS: Across the 4 prioritized domains of "condition," "technology," "value proposition," and "adopters," 48 digital health implementation considerations and 52 tailored developer and clinician implementation strategies were generated. Benefits and challenges of coproduction were identified. The post hoc network analysis revealed 172 unique relationships between the identified implementation considerations and strategies, with user and persona testing and responsive design identified as the potentially most impactful strategies. CONCLUSIONS: People with ABI, close others, clinicians, and digital health leaders coproduced new knowledge of digital health implementation considerations for adults with ABI and the people who communicate with them, as well as tailored implementation strategies. Complexity-informed network analyses offered a data-driven method to identify the 2 most potentially impactful strategies. Although the study was limited by a focus on 4 NASSS domains and the underrepresentation of certain demographics, the wealth of actionable implementation knowledge produced supports future coproduction of implementation research with mutually beneficial outcomes for stakeholders and researchers. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/35080.

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.

Feasibility of home-based exercise training during adjuvant treatment for metastatic castrate-resistant prostate cancer patients treated with an androgen receptor pathway inhibitor (EXACT).

BACKGROUND: Exercise is an effective adjuvant therapy that can alleviate treatment-related toxicities for men with prostate cancer (PC). However, the feasibility of delivering exercise training to men with advanced disease and the wider impact on clinical outcomes remain unknown. The purpose of the EXACT trial was to determine the feasibility and effects of home-based exercise training in men with metastatic castrate-resistant prostate cancer (mCRPC). METHODS: Patients with mCRPC receiving ADT + an androgen receptor pathway inhibitor (ARPI) were prescribed 12 weeks of home-based, remotely monitored, moderate intensity, aerobic and resistance exercise. Feasibility was assessed using recruitment, retention and adherence rates. Safety and adverse events were monitored throughout, with functional and patient-reported outcomes captured at baseline, post-intervention and at 3-month follow-up. RESULTS: From the 117 screened, 49 were deemed eligible and approached, with 30 patients providing informed consent (61% recruitment rate). Of those who consented, 28 patients completed baseline assessments, with 24 patients completing the intervention and 22 completing follow-up (retention rates: 86% and 79% respectively). Task completion was excellent throughout, with no intervention-related adverse events recorded. Self-reported adherence to the overall intervention was 82%. Exercise training decreased mean body mass (-1.5%), improved functional fitness (> 10%) and improved several patient-reported outcomes including clinically meaningful changes in fatigue (p = 0.042), FACT-G (p = 0.054) and FACT-P (p = 0.083), all with moderate effect sizes. CONCLUSION: Home-based exercise training, with weekly remote monitoring, was feasible and safe for men with mCRPC being treated with an ARPI. Given that treatment-related toxicities accumulate throughout the course of treatment, and as a result, negatively impact functional fitness and health-related quality of life (HRQoL), it was positive that exercise training improved or prevented a decline in these clinically important variables and could better equip patients for future treatment. Collectively, these preliminary feasibility findings support the need for a definitive, larger RCT, which downstream may lead to the inclusion of home-based exercise training as part of adjuvant care for mCRPC.