Sian L Wells

Effect of intervention aimed at increasing physical activity, reducing sedentary behaviour, and increasing fruit and vegetable consumption in children: Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial

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.

Characteristics associated with requested and required accelerometer wear in children

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.

Long-term effects of the Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial

Objective To investigate the long-term effectiveness of a school-based intervention to improve physical activity and diet in children. Design Cluster-randomised controlled trial. Setting 60 primary schools in the southwest of England. Participants Primary 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. Intervention Teacher training, provision of lesson and child–parent interactive homework plans and teaching materials. Main outcome measures Primary 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. Results 60 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. Conclusions School-based curriculum interventions alone are unlikely to have a major public health impact on childrens diet and physical activity. Trial registration number ISRCTN50133740, Post-results.

NAP SACC UK: protocol for a feasibility cluster randomised controlled trial in nurseries and at home to increase physical activity and healthy eating in children aged 2-4 years.

Introduction Systematic reviews have identified the lack of intervention studies with young children to prevent obesity. This feasibility study examines the feasibility and acceptability of adapting the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) intervention in the UK to inform a full-scale trial. Methods and analysis A feasibility cluster randomised controlled trial in 12 nurseries in England, with 6 randomly assigned to the adapted NAP SACC UK intervention: nursery staff will receive training and support from an NAP SACC UK Partner to review the nursery environment (nutrition, physical activity, sedentary behaviours and oral health) and set goals for making changes. Parents will be invited to participate in a digital media-based home component to set goals for making changes in the home. As this is a feasibility study, the sample size was not based on a power calculation but will indicate the likely response rates and intracluster correlations. Measures will be assessed at baseline and 8–10 months later. We will estimate the recruitment rate of nurseries and children and adherence to the intervention and data. Nursery measurements will include the Environmental Policy Assessment and Observation score and the nursery staffs review of the nursery environment. Child measurements will include height and weight to calculate z-score body mass index (zBMI), accelerometer-determined minutes of moderate-to-vigorous physical activity per day and sedentary time, and diet using the Child and Diet Evaluation Tool. Questionnaires with nursery staff and parents will measure mediators. A process evaluation will assess fidelity of intervention delivery and views of participants. Ethics and dissemination Ethical approval for this study was given by Wales 3 NHS Research Ethics Committee. Findings will be made available through publication in peer-reviewed journals, at conferences and to participants via the University of Bristol website. Data will be available from the University of Bristol Research Data Repository. Trial registration number ISRCTN16287377.

P25 Feasibility cluster randomised controlled trial and process evaluation of an environmental intervention in nurseries and a web-based home intervention to increase physical activity, oral health and healthy eating in children aged 2–4 years: nap sacc uk

Background Systematic reviews have identified the lack of intervention studies to prevent obesity in young children. Most 3 year old children in the UK attend formal childcare, and the Government plans to extend free childcare to 30 hours per week for 3 and 4 year olds; therefore these settings present an opportunity to improve health. The Nutrition and Physical Activity Self Assessment for Childcare (NAP SACC) programme aims to improve child nutrition and physical activity through changes to the nursery environment. Feasibility and acceptability have been demonstrated through Randomised Controlled Trials (RCT) in the USA. This study examined the feasibility and acceptability of adapting the NAP SACC intervention for the UK. Methods A feasibility cluster RCT in 12 nurseries with 2–4 year olds in the southwest region of England. Focus groups and interviews with Health Visitors (community children’s nurses), nursery staff and parents informed adaptation of the intervention for the UK. The intervention comprised: two staff workshops on physical activity and nutrition; Health Visitor support to review nursery practices against 80 areas of best practice, set goals and make changes; a digital media-based home component. Measures were assessed at baseline and post-intervention: zBMI, accelerometer-measured physical activity and sedentary time, diet, child quality of life, health care usage, parental and nursery staff mediators and quality of nursery environment. Fidelity and acceptability were assessed through observation and interviews analysed via thematic analysis. Results Formative work resulted in the following adaptations: inclusion of an oral health component; changes to confirm with UK guidance; specialist workshop facilitators; and development of the home component. 168 (37%) eligible children were recruited from 12 nurseries. Interviews were completed with four Health Visitors, 17 nursery staff and 20 parents. The intervention was implemented with high fidelity, with two exceptions: one nursery did not implement the intervention due to staff workload; and the digital home component was used by just 12 (14%) parents. Intervention acceptability was high. A mean of seven staff per nursery attended each workshop. The workshops and Health Visitor contact were highly valued. The mean number of goals set was eight. Nursery changes included: menu modifications, reducing portion sizes and sugary snacks, role modelling physical activity and eating, and active story telling. The trial design and methods were highly acceptable. Descriptive analysis of the outcomes will be available by September 2017. Conclusion NAP SACC UK is feasible and acceptable with the exception of the home component; effectiveness should be tested through a full-scale RCT.

NAP SACC UK

Introduction Systematic reviews have identified the lack of intervention studies with young children to prevent obesity. This feasibility study examines the feasibility and acceptability of adapting the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) intervention in the UK to inform a full-scale trial. Methods and analysis A feasibility cluster randomised controlled trial in 12 nurseries in England, with 6 randomly assigned to the adapted NAP SACC UK intervention: nursery staff will receive training and support from an NAP SACC UK Partner to review the nursery environment (nutrition, physical activity, sedentary behaviours and oral health) and set goals for making changes. Parents will be invited to participate in a digital media-based home component to set goals for making changes in the home. As this is a feasibility study, the sample size was not based on a power calculation but will indicate the likely response rates and intracluster correlations. Measures will be assessed at baseline and 8–10 months later. We will estimate the recruitment rate of nurseries and children and adherence to the intervention and data. Nursery measurements will include the Environmental Policy Assessment and Observation score and the nursery staffs review of the nursery environment. Child measurements will include height and weight to calculate z-score body mass index (zBMI), accelerometer-determined minutes of moderate-to-vigorous physical activity per day and sedentary time, and diet using the Child and Diet Evaluation Tool. Questionnaires with nursery staff and parents will measure mediators. A process evaluation will assess fidelity of intervention delivery and views of participants. Ethics and dissemination Ethical approval for this study was given by Wales 3 NHS Research Ethics Committee. Findings will be made available through publication in peer-reviewed journals, at conferences and to participants via the University of Bristol website. Data will be available from the University of Bristol Research Data Repository. Trial registration number ISRCTN16287377.

NAP SACC UK: protocol for a feasibility cluster randomised controlled trial in nurseries and at home to increase physical activity and healthy eating in 2-4 year olds

Introduction Systematic reviews have identified the lack of intervention studies with young children to prevent obesity. This feasibility study examines the feasibility and acceptability of adapting the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) intervention in the UK to inform a full-scale trial. Methods and analysis A feasibility cluster randomised controlled trial in 12 nurseries in England, with 6 randomly assigned to the adapted NAP SACC UK intervention: nursery staff will receive training and support from an NAP SACC UK Partner to review the nursery environment (nutrition, physical activity, sedentary behaviours and oral health) and set goals for making changes. Parents will be invited to participate in a digital media-based home component to set goals for making changes in the home. As this is a feasibility study, the sample size was not based on a power calculation but will indicate the likely response rates and intracluster correlations. Measures will be assessed at baseline and 8–10 months later. We will estimate the recruitment rate of nurseries and children and adherence to the intervention and data. Nursery measurements will include the Environmental Policy Assessment and Observation score and the nursery staffs review of the nursery environment. Child measurements will include height and weight to calculate z-score body mass index (zBMI), accelerometer-determined minutes of moderate-to-vigorous physical activity per day and sedentary time, and diet using the Child and Diet Evaluation Tool. Questionnaires with nursery staff and parents will measure mediators. A process evaluation will assess fidelity of intervention delivery and views of participants. Ethics and dissemination Ethical approval for this study was given by Wales 3 NHS Research Ethics Committee. Findings will be made available through publication in peer-reviewed journals, at conferences and to participants via the University of Bristol website. Data will be available from the University of Bristol Research Data Repository. Trial registration number ISRCTN16287377.