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Background The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA. A feasibility randomised controlled trial was conducted in England to adapt the intervention to the UK context. An embedded process evaluation focused on three key questions. 1. Was it feasible and acceptable to implement the intervention as planned? 2. How did the intervention affect staff and parent mediators? 3. Were the trial design and methods acceptable? Methods Twelve nurseries in south-west England were recruited and randomised to intervention or control. The intervention comprised: NAP SACC UK Partner (Health Visitor) support to nurseries to review practice and policies against best practice, and then set goals to improve physical activity, nutrition and oral health; two staff training workshops; and a web-based parent support element. The process evaluation comprised: observations of Partner training ( n  = 1), Partner/manager meetings ( n  = 5) and staff workshops ( n  = 10); semi-structured interviews with Partners ( n  = 4), managers ( n  = 12), staff (n = 4) and parents ( n  = 20); analysis of self-assessment forms, goal setting forms and Partner logbooks; and assessment of staff and parent knowledge, motivation and self-efficacy mediators. Results Overall, NAP SACC UK was feasible to implement and acceptable to nursery staff, managers, Partners and parents. The intervention was implemented as planned in five of the six intervention nurseries. Partners and managers appreciated the opportunity to review and improve nursery practices and valued the relationship forged between them. Staff rated the training workshops highly, despite attending outside of working hours. Most goals set by nurseries were achieved. However, Partners raised concerns about Health Visitors’ capacity to deliver the intervention in any subsequent roll out. Mediator scores improved in all but two areas in intervention staff and parents, with decreases or minimal changes in the control group. The web-based parent element was not well used and should be removed from any subsequent trial. The trial methods were acceptable to managers, staff, Partners and parents. Conclusions Implementing and evaluating a physical activity and nutrition intervention in nursery settings is feasible and acceptable. A full RCT of NAP SACC UK (with appropriate modifications) is warranted. Trial registration ISRCTN16287377 (10 Apr 2015).

Background Childhood obesity tracks into adulthood with detrimental effects on health. We aimed to examine the relationships of diet in childcare settings and daily physical activity (PA) of preschoolers with body mass index z-score (z-BMI). Methods We conducted a cross-sectional study of 150 children aged 2–4-years participating in the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) UK study to examine the associations of their diet in childcare settings and daily PA with z-BMI. Dietary intake was observed and recorded by fieldworkers using a validated tick-list food questionnaire and diet quality was assessed based on adherence to Children’s Food Trust (CFT) guidelines. PA was measured using accelerometers. We derived z-BMI scores using the UK 1990 and International Obesity Taskforce growth reference charts. Multilevel regression models were used to estimate associations between diet and PA with z-BMI separately, adjusted for age, gender, ethnicity, parental education level and clustering. Results Among children who consumed one main meal or snack at childcare, 34.4% and 74.3% met the standards on fruits and vegetables and high sugar or fat snacks, respectively. Adherence to CFT guidelines was not associated with zBMI. Only 11.4% of children met recommended UK guidelines of three hours per day of physical activity. Minutes spent in light PA (β = 0.08, 95% CI = 0.01, 0.15) and active time (β = 0.07, 95% CI = 0.01, 0.12) were positively associated with UK 1990 zBMI scores. Conclusions The low proportion of children meeting the standards on fruits and vegetables and high sugar or fat snacks and recommended physical activity levels highlight the need for more work to support nurseries and parents to improve preschool children’s diet and activity. In our exploratory analyses, we found children with higher zBMI were more physically active which could be attributed to fat-free mass or chance finding and so requires replication in a larger study. Trial registration ISRCTN16287377 . Registered 12 June 2014.

IntroductionAtopic dermatitis/eczema affects around 20% of children and is characterised by inflamed, dry, itchy skin. Guidelines recommend ‘leave-on’ emollients that are applied directly to the skin to add or trap moisture and used regularly, they can soothe, enhance the skin barrier and may prevent disease ‘flares’. However, the suitability of the many different emollients varies between people and there is little evidence to help prescribers and parents and carers decide which type to try first.Methods and analysisDesign: pragmatic, multicentre, individually randomised, parallel group superiority trial of four types of emollient (lotions, creams, gel or ointments).Setting: general practitioner surgeries in England.Participants: children aged over 6 months and less than 12 years with mild-to-severe eczema and no known sensitivity to study emollients.Interventions: study-approved lotion, cream, gel or ointment as the only leave-on emollient for 16 weeks, with directions to apply twice daily and as required. Other treatments, such as topical corticosteroids, used as standard care.Follow-up: 52 weeks.Primary outcome: validated patient-orientated eczema measure measured weekly for 16 weeks.Secondary outcomes: eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact).Sample size: 520 participants (130 per group).Analysis: intention-to-treat using linear mixed models for repeated measures.Nested qualitative study: audio-recording of sample of baseline appointments and up to 60 interviews with participants at 4 and 16 weeks, interviews to be transcribed and analysed thematically.Ethics and disseminationEthics approval granted by the NHS REC (South West - Central Bristol Research Ethics Committee 17/SW/0089). Findings will be presented at conferences, published in open-access peer-reviewed journals and the study website; and summaries shared with key stakeholders.Trial registration numberISRCTN84540529

Most children in the UK attend formal childcare from the age of 3 years, so it is important that these settings promote healthy behaviours and reduce risk of obesity. The Nutrition and Physical Activity Self-Assessment for Childcare (NAP SACC) programme works with nurseries to produce changes in the environment and improvements in children's nutrition and physical activity. Randomised controlled trials have demonstrated the feasibility and acceptability of NAP SACC in the USA, but not in the UK. This study aimed to adapt NAP SACC for use in the UK and to develop a home component to involve parents for use in a feasibility trial (NAP SACC UK). A purposive sample of 16 nurseries in North Somerset and Cardiff were invited to inform the development of NAP SACC UK. The areas were selected to include a range of ethnicity, deprivation, and rural and urban areas. 12 nurseries consented to participate. Health visitors and early years' staff participated in focus groups. Parents or carers with children aged 2–4 years at participating nurseries were invited to discuss parental involvement during telephone interviews. All interview recordings were transcribed verbatim and anonymised. Meaningful content was coded with thematic analysis. Five focus groups with early years' staff (n=17), ten nursery manager interviews, and 31 parent interviews were held. Staff were positive about the NAP SACC approach of self-assessment, use of action planning, and staff workshops. Although health-visitor involvement was welcomed, lack of capacity or knowledge to deliver workshops was a concern. Participants expressed concern about child oral health and interest in including it. Parents suggested involving the whole family in the home component and linking with themes in nurseries. Online tip-sharing forums for parents were also suggested. The approach used by NAP SACC was broadly acceptable to nurseries in the UK, with recommendations to deliver training and to include oral health. Parents welcomed support at home. Because North Somerset and Cardiff have different approaches to health improvement, and participants were recruited from a range of nurseries, the findings are to some extent generalisable to other areas within the UK. National Institute for Health Research (NIHR) Public Health Research Programme (PHR 12/153/39). NIHR paid the salaries of SW and RB.

Objective To investigate the effectiveness of a school based intervention to increase physical activity, reduce sedentary behaviour, and increase fruit and vegetable consumption in children.Design Cluster randomised controlled trial.Setting 60 primary schools in the south west of England.Participants Primary school children who were in school year 4 (age 8-9 years) at recruitment and baseline assessment, in year 5 during the intervention, and at the end of year 5 (age 9-10) at follow-up assessment.Intervention The Active for Life Year 5 (AFLY5) intervention consisted of teacher training, provision of lesson and child-parent interactive homework plans, all materials required for lessons and homework, and written materials for school newsletters and parents. The intervention was delivered when children were in school year 5 (age 9-10 years). Schools allocated to control received standard teaching.Main outcome measures The pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day, accelerometer assessed minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables.Results 60 schools with more than 2221 children were recruited; valid data were available for fruit and vegetable consumption for 2121 children, for accelerometer assessed physical activity and sedentary behaviour for 1252 children, and for secondary outcomes for between 1825 and 2212 children for the main analyses. None of the three primary outcomes differed between children in schools allocated to the AFLY5 intervention and those allocated to the control group. The difference in means comparing the intervention group with the control group was –1.35 (95% confidence interval –5.29 to 2.59) minutes per day for moderate to vigorous physical activity, –0.11 (–9.71 to 9.49) minutes per day for sedentary behaviour, and 0.08 (–0.12 to 0.28) servings per day for fruit and vegetable consumption. The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account: self reported time spent in screen viewing at the weekend (–21 (–37 to –4) minutes per day), self reported servings of snacks per day (–0.22 (–0.38 to –0.05)), and servings of high energy drinks per day (–0.26 (–0.43 to –0.10)) were all reduced. Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results.Conclusion The findings suggest that the AFLY5 school based intervention is not effective at increasing levels of physical activity, decreasing sedentary behaviour, and increasing fruit and vegetable consumption in primary school children. Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level, as well as at the school environment level. These findings have relevance for researchers, policy makers, public health practitioners, and doctors who are involved in health promotion, policy making, and commissioning services.Trial registration Current Controlled Trials ISRCTN50133740.

Objective To investigate characteristics associated with wearing an accelerometer for the required and requested time among 8-year-old to 10-year-old children. Design Cross-sectional. Setting 60 Bristol and North Somerset primary schools taking part in the ‘Active for Life Year 5’ randomised controlled trial (RCT) in 2011. Participants 2048 children, aged 8–10 years, invited to wear an accelerometer for 5 days of recording. Primary outcome measure Numbers meeting required wear-time for inclusion in main RCT analysis (≥8 h/day ≥3 days) and numbers meeting requested wear-time (≥8 h/day for all 5 days). Results 817 (40%) of the children wore the accelerometer for the requested time and 1629 (80%) for the required time. In adjusted multivariable analyses the odds of wearing the accelerometer for the required time were greater in females as compared with males (OR 1.76 (1.42–2.18)), those with higher scores for reporting their mother restricted time on sedentary behaviours (1.26 (1.04–1.52) per increase of 1 on a 1–4 scale) and in children from schools with larger year group sizes (1.01 (1.00–1.02) per additional child). Living in a neighbourhood with higher levels of deprivation (0.49 (0.33–0.72) comparing highest to lowest third of the deprivation score) or reporting higher levels of weekday outdoor play (0.97 (0.94, 1.00) per 30 min more) were associated with reduced odds of meeting required time. Results were essentially the same for requested wear-time. Other characteristics, including child body mass index, were not associated with required or requested wear-time. Conclusions Only 40% of children wore the accelerometer for the requested time but 80% fulfilled the required criteria to be included in the main study analyses. Knowing which characteristics are associated with accelerometer wear could help target interventions to increase wear-time.

ObjectiveTo investigate the long-term effectiveness of a school-based intervention to improve physical activity and diet in children.DesignCluster-randomised controlled trial.Setting60 primary schools in the southwest of England.ParticipantsPrimary school children who were aged 8–9 years at recruitment, 9–10 years during the intervention and 10–11 years at the long-term follow-up assessment.InterventionTeacher training, provision of lesson and child–parent interactive homework plans and teaching materials.Main outcome measuresPrimary outcomes were accelerometer-assessed minutes of moderate to vigorous physical activity (MVPA) per day, accelerometer-assessed minutes of sedentary behaviour per day and reported daily consumption of servings of fruit and vegetables.Results60 schools with 2221 eligible children were recruited. As in the previously published assessment immediately after the end of the intervention, none of the three primary outcomes differed between children in schools allocated to the intervention, compared with those in control schools at the end of the long-term follow-up (1 year after the end of the intervention). Differences in secondary outcomes were consistent with those at the immediate follow-up, with no evidence that these had diminished over time. Comparing intervention with control schools, the difference in mean child-reported screen viewing at the weekend was −16.03 min (95% CI −32.82 to 0.73), for servings of snacks per day, the difference was −0.11 (95% CI −0.39 to 0.06), in servings of high-energy drinks per day −0.20 (95% CI −0.39 to −0.01) and in servings of high-fat foods per day −0.12 (95% CI −0.39 to 0.00). None of these reached our predefined level of statistical significance, especially after accounting for multiple testing.ConclusionsSchool-based curriculum interventions alone are unlikely to have a major public health impact on children's diet and physical activity.Trial registration numberISRCTN50133740, Post-results.

Background Active for Life Year 5 (AFLY5) is an educational programme for Year 5 children (aged 9–10) designed to increase children’s physical activity, decrease sedentary behaviour and increase fruit and vegetable intake. This paper reports findings from a process evaluation embedded within a randomised controlled trial evaluating the programme’s effectiveness. It considers the fidelity of implementation of AFLY5 with a focus on three research questions: To what extent was the intervention delivered as planned? In what ways, if any, did the teachers amend the programme? and What were the reasons for any amendments? Methods Mixed methods were used including data collection via observation of the intervention delivery, questionnaire, teacher’s intervention delivery log and semi-structured interviews with teachers and parents. Qualitative data were analysed thematically and quantitative data were summarised using descriptive statistics. Results Following training, 42 of the 43 intervention school teachers/teaching staff (98 %) were confident they could deliver the nutrition and physical activity lessons according to plan. The mean number of lessons taught was 12.3 (s.d. 3.7), equating to 77 % of the intervention. Reach was high with 95 % of children in intervention schools receiving lessons. A mean of 6.2 (s.d. 2.6) out of 10 homeworks were delivered. Median lesson preparation time was 10 min (IQR 10–20) and 28 % of lessons were reported as having been amended. Qualitative findings revealed that those who amended the lessons did so to differentiate for student ability, update them for use with new technologies and to enhance teacher and student engagement. Teachers endorsed the aims of the intervention, but some were frustrated with having to adapt the lesson materials. Teachers also a reported tendency to delegate the physical activity lessons to other staff not trained in the intervention. Conclusions Fidelity of intervention implementation was good but teachers’ enthusiasm for the AFLY5 programme was mixed despite them believing that the messages behind the lessons were important. This may have meant that the intervention messages were not delivered as anticipated and explain why the intervention was found not to be effective. Trial registration ISRCTN50133740 .

Abstract Background Post herpetic neuralgia (PHN) is the most common complication of herpes zoster, also known as shingles. Amitriptyline has been postulated to prevent PHN. The objective is to determine whether prophylactic low-dose amitriptyline prevents PHN in patients newly diagnosed with shingles. Methods This is a multicentre, individually randomized, pragmatic, placebo-controlled superiority trial with health economic analysis and nested qualitative study. Patients with new-onset shingles are screened by treating clinicians in participating general practitioner surgeries. Key eligibility criteria are age ≥50 years, ≤6 days since rash onset and not already taking (and no contraindication to) amitriptyline. Participants are randomized 1:1 to amitriptyline 10 mg or matched placebo tablets (dose escalated as tolerated to a maximum of three tablets daily for 70 days). Resource-use data (including health, social and informal care, personal expenses and usual activities) are collected from electronic medical records and participant questionnaires. A sample of recruitment conversations are audio-recorded and interviews conducted with recruiters and patients, including those who decline to participate or who withdraw from the trial. Discussion The primary outcome is the presence of PHN (≥3/10 worst pain on Zoster Brief Pain Inventory) at 90 days after rash onset. Primary health economic analyses will present cost per case of PHN prevented and cost per quality-adjusted life year. Qualitative data will be analysed to optimize trial delivery and to aid interpretation and implementation of the trial findings. This is the largest trial to date to evaluate the clinical/cost-effectiveness and acceptability of prophylactic low-dose amitriptyline for the prevention of PHN. Protocol registration EudraCT 2021-001101-78 and ISRCTN14490832. The ATHENA study is the largest study in the world to investigate whether prophylactic low-dose amitriptyline prevents post herpetic neuralgia, the most common complication of herpes zoster (shingles). This protocol paper describes the design and conduct of this multi-centre, individually randomized, pragmatic, placebo-controlled superiority trial in primary care with health economic analysis and nested qualitative study.

Background Active for life year 5 (AFLY5) is a school-based intervention, based on social cognitive theory, which aims to promote healthy levels of physical activity and healthy eating by improving a child’s self-efficacy to make healthy choices, their knowledge of how to make such choices and prompting parents to support their children to make healthy choices. Previously published results showed no effect on the three primary outcomes and beneficial effects on three of nine secondary outcomes (time spent screen-viewing at weekends, consumption of snacks and of high energy drinks). This paper aims to determine the effect of the intervention on potential mediators. Methods We conducted a cluster RCT of a school-based intervention, with allocation concealed by use of a remote system. The study was undertaken in the South West of England between 2011 and 2013. Participants were school children who were age 8–9 years at baseline assessment and 9–10 years during the intervention. Potential mediators were assessed at the end of the intervention. The intervention consisted of teacher training, provision of all materials required for lessons and homeworks and written materials for school newsletters and parents. The ten potential mediators were child-reported self-efficacy for physical activity and fruit and vegetable consumption, perceived parental logistic support and modelling for their child’s physical activity, parental efforts to limit their child’s sedentary behaviour and modelling of healthy fruit and vegetable consumption, together with a knowledge assessment. Results We successfully recruited 60 schools with over 2,221 children; valid data for the 10 mediators were available for 87 % to 96 % of participants. Three of the ten potential mediators were greater in the intervention, compared with the control group: fruit and vegetable self-efficacy 2.2 units (95 % CI: 0.7 to 3.8), assessed on a scale 26 to 130; child-reported maternal limitation of sedentary behaviour 0.5 (0.1 to 0.8), scale 4 to 16; and knowledge 0.5 (0.2, 0.7) scale 0 to 9. Reported maternal limitation of sedentary behaviour and the child’s knowledge explained 23 % of the effect of the intervention on reducing time spent on sedentary behaviour at the weekend. There was no effect on other mediators. Conclusions Our findings suggest that the effect of the AFLY5 intervention on reducing screen-viewing at weekends was partially mediated by an effect on mothers limiting their child’s time spent sedentary and on increasing the child’s knowledge about healthy behaviour. However, overall our findings suggest that theory driven interventions, like AFLY5, can fail to influence most potential mediators and this may explain the failure of the intervention to improve most primary and secondary outcomes. Trial registration Current Controlled Trials ISRCTN50133740 . Registered 17/03/2011