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Why you should read this article: • UK care homes are an important example of a complex environment where research is essential but faces multiple challenges in terms of rigour and methodology • This paper offers a variety of important methodological strategies to identify and address challenges that could impact findings and the ability to carry out research • It highlights the importance of taking a critical stance with all elements of the research process and illustrates the need to identify and mitigate challenges when conducting research in complex environments. Background: The evidence base for hydration practice in care homes is underdeveloped. High-quality research is therefore needed to determine what practices support older people with dementia in drinking sufficient fluid. However, methodological developments are needed to be able to do this. Aim: To highlight the methodological issues researchers encountered during a feasibility cluster, randomised controlled trial of ThinkDrink, a hydration care guide for people with dementia living in UK care homes. Discussion: This is a challenging area because of the complexity of recruitment, participation and data collection in care homes. Researchers must pay extra attention to rigour and quality in the design of their studies. There may be multiple challenges, so various strategies may be required. Conclusion: It is important that researchers continue to reflect on rigorous approaches to develop evidence in a crucial area of care, despite these challenges. Implications for practice: Researchers working in complex environments face a variety of challenges to complete methodologically rigorous research. It is important for researchers to be critical of research processes and data, to mitigate and overcome these challenges. [ABSTRACT FROM AUTHOR]

Background: In many Westernised countries, children do not consume a sufficient amount of vegetables for optimal health and development. Child-feeding guidelines have been produced to address this, but often only promote offering vegetables at midday/evening meals and snack times. With guidance having limited success in increasing children's vegetable intake at a population level, novel approaches to address this must be developed. Offering vegetables to children at breakfast time in nursery/kindergarten settings has the potential to increase children's overall daily vegetable consumption as children typically attend nursery/kindergarten and many routinely eat breakfast there. However, the feasibility and acceptability of this intervention (Veggie Brek) to children and nursery staff has not been investigated. Methods: A feasibility and acceptability cluster randomised controlled trial (RCT) was undertaken in eight UK nurseries. All nurseries engaged in one-week baseline and follow-up phases before and after an intervention/control period. Staff in intervention nurseries offered three raw carrot batons and three cucumber sticks alongside children's main breakfast food each day for three weeks. Control nurseries offered children their usual breakfast. Feasibility was assessed by recruitment data and nursery staff's ability to follow the trial protocol. Acceptability was assessed by children's willingness to eat the vegetables at breakfast time. All primary outcomes were assessed against traffic-light progression criteria. Staff preference for collecting data via photographs versus using paper was also assessed. Further views about the intervention were obtained through semi-structured interviews with nursery staff. Results: The recruitment of parents/caregivers willing to provide consent for eligible children was acceptable at 67.8% (within the amber stop–go criterion) with 351 children taking part across eight nurseries. Both the feasibility and acceptability of the intervention to nursery staff and the willingness of children to consume the vegetables met the green stop–go criteria, with children eating some part of the vegetables in 62.4% (745/1194) of instances where vegetables were offered. Additionally, staff preferred reporting data using paper compared to taking photographs. Conclusions: Offering vegetables to children at breakfast time in nursery/kindergarten settings is feasible and acceptable to children and nursery staff. A full intervention evaluation should be explored via a definitive RCT. Trial registration: NCT05217550. [ABSTRACT FROM AUTHOR]

Background. The implementation of a complex intervention is heavily influenced by individual context. Variation in implementation and tailoring of the intervention to the particular context will occur, even in a trial setting. It is recognised that in trials, evaluating the process of implementation of a complex intervention is important, yet process evaluation methods are rarely reported. The WAVES study is a cluster randomised controlled trial to evaluate the effectiveness of an obesity prevention intervention programme targeting children aged 6–7 years, delivered by teachers in primary schools across the West Midlands, UK. The intervention promoted activities encouraging physical activity and healthy eating. This paper presents the methods used to assess implementation of the intervention. Methods. Previous literature was used to identify the dimensions of intervention process and implementation to be assessed, including adherence, exposure, quality of delivery, participant responsiveness, context, and programme differentiation. Results. Multiple methods and tools were developed to capture information on all these dimensions. These included observations, logbooks, qualitative evaluation, questionnaires and research team reflection. Discussion. Data collection posed several challenges, predominantly when relying on teachers to complete paperwork, which they saw as burdensome on top of their teaching responsibilities. However, the use of multiple methods helped to ensure data on each dimension, where possible, was collected using more than one method. This also allowed for triangulation of the findings when several data sources on any one dimension were available. Conclusions. We have reported a comprehensive approach to the assessment of the implementation and processes of a complex childhood obesity prevention intervention within a cluster randomised controlled trial. These approaches can be transferred and adapted for use in other complex intervention trials. [ABSTRACT FROM AUTHOR]

Background: In response to increasing policy action and public concern about the negative health effects of sugar-sweetened beverages (SSBs), there is increased promotion of artificially sweetened beverages (ASBs). These have been linked with obesity and diabetes in recent experimental work. This study examined associations between SSB and ASB consumption and changes in adiposity in a nationally representative sample of UK children. Methods: We conducted a longitudinal study of 13,170 children aged 7-11 years in the UK Millennium Cohort Study, collected in 2008 and 2012. Logistic regression was used to assess socio-demographic and behavioural correlates of weekly SSB and ASB consumption at 11 years. Linear regression examined associations between SSB/ASB consumption and changes in adiposity measures between 7 and 11 years. Results: Boys were more likely to consume SSBs weekly (62.3 % v 59.1 %) than girls at age 11 years. South Asian children were more likely to consume SSBs weekly (78.8 % v 58.4 %) but less likely to consume ASBsweekly (51.7 % v 66.3 %) than White children. Daily SSB consumption was associated with increases in percentage body fat between ages 7 and 11 (+0.57 %, 95 % confidence intervals 0.30;0.83). Daily ASB consumption was associated with increased percentage body fat at age 11 (+1.18 kg/m², 0.81;1.54) and greater increases between ages 7 and 11 (+0.35 kg/m², 0.09;0.61). Conclusion: Consumption of SSBs and ASBs was associated with BMI and percentage body fat increases in UK children. Obesity prevention strategies which encourage the substitution of SSBs with ASBs may not yield the adiposity benefits originally intended and this area should be a focus for further research. [ABSTRACT FROM AUTHOR]

Background. Extracurricular programmes could provide a mechanism to increase the physical activity (PA) of primary-school-aged children. The aim of this feasibility study was to examine whether the Action 3:30 intervention, which is delivered by teaching assistants, holds promise as a means of increasing the PA of Year 5 and 6 children. Methods. A cluster randomised feasibility trial was conducted in 20 primary schools. Ten schools received the Action 3:30 intervention and 10 schools were allocated to the control arm. The intervention was 40 one-hour sessions, delivered twice a week by teaching assistants. The proportion of participants recruited per school was calculated. Session delivery and session attendance was calculated for intervention schools. Weekday and after-school (3.30 to 8.30 pm) moderate to vigorous intensity physical (MVPA) was assessed by accelerometer at baseline (T0), during the last few weeks of the intervention (T1) and four months after the intervention had ended (T2). The costs of delivering the intervention were estimated. Results. Five intervention schools ran all 40 of the intended sessions. Of the remaining five, three ran 39, one ran 38 and one ran 29 sessions. Mean attendance was 53%. The adjusted difference in weekday MVPA at T1 was 4.3 minutes (95% CI −2.6 to 11.3). Sex-stratified analyses indicated that boys obtained 8.6 more minutes of weekday MVPA than the control group (95% CI 2.8 to 14.5) at T1 with no effect for girls (0.15 minutes, 95% CI −9.7 to 10.0). There was no evidence that participation in the programme increased MVPA once the club sessions ceased (T2). The indicative average cost of this intervention was £2,425 per school or £81 per participating child during its first year and £1,461 per school or £49 per participating child thereafter. Conclusions. The effect of the Action 3:30 interventions was comparable to previous physical activity interventions but further analysis indicated that there was a marked sex difference with a positive impact on boys and no evidence of an effect on girls. The Action 3:30 intervention holds considerable promise but more work is needed to enhance the effectiveness of the intervention, particularly for girls. [ABSTRACT FROM AUTHOR]