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1.  Characteristics associated with requested and required accelerometer wear in children 
BMJ Open  2013;3(8):e003402.
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.
doi:10.1136/bmjopen-2013-003402
PMCID: PMC3753482  PMID: 23975106
Epidemiology; Public Health; Sports MEdicine
2.  The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan 
Trials  2013;14:234.
Background
The Active For Life Year 5 (AFLY5) randomised controlled trial protocol was published in this journal in 2011. It provided a summary analysis plan. This publication is an update of that protocol and provides a detailed analysis plan.
Update
This update provides a detailed analysis plan of the effectiveness and cost-effectiveness of the AFLY5 intervention. The plan includes details of how variables will be quality control checked and the criteria used to define derived variables. Details of four key analyses are provided: (a) effectiveness analysis 1 (the effect of the AFLY5 intervention on primary and secondary outcomes at the end of the school year in which the intervention is delivered); (b) mediation analyses (secondary analyses examining the extent to which any effects of the intervention are mediated via self-efficacy, parental support and knowledge, through which the intervention is theoretically believed to act); (c) effectiveness analysis 2 (the effect of the AFLY5 intervention on primary and secondary outcomes 12 months after the end of the intervention) and (d) cost effectiveness analysis (the cost-effectiveness of the AFLY5 intervention). The details include how the intention to treat and per-protocol analyses were defined and planned sensitivity analyses for dealing with missing data. A set of dummy tables are provided in Additional file 1.
Discussion
This detailed analysis plan was written prior to any analyst having access to any data and was approved by the AFLY5 Trial Steering Committee. Its publication will ensure that analyses are in accordance with an a priori plan related to the trial objectives and not driven by knowledge of the data.
Trial registration
ISRCTN50133740
doi:10.1186/1745-6215-14-234
PMCID: PMC3733690  PMID: 23883177
3.  The Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial: study protocol for a randomized controlled trial 
Trials  2011;12:181.
Background
Low levels of physical activity, high levels of sedentary behaviour and low levels of fruit and vegetable consumption are common in children and are associated with adverse health outcomes. The aim of this paper is to describe the protocol for a cluster randomised controlled trial (RCT) designed to evaluate a school-based intervention that aims to increase levels of physical activity, decrease sedentary behaviour and increase consumption of fruit and vegetables in school children.
Methods/design
The Active for Life Year 5 (AFLY5) study is a school-based, cluster RCT that targets school children in Year 5 (age 9-10 years). All state junior/primary schools in the area covered by Bristol City and North Somerset Council are invited to participate; special schools are excluded. Eligible schools are randomised to one of two arms: intervention arm (receive the intervention 2011-2012) and control arm (receive the intervention after the final follow-up assessment, 2013-2014). The primary outcomes of the trial are levels of accelerometer assessed physical activity and sedentary behaviour and questionnaire assessed fruit and vegetable consumption. A number of secondary outcomes will also be measured, including body mass index, waist circumference and overweight/obesity. Outcomes will be assessed at baseline (prior to intervention when the children are in Year 4), at the end of intervention 'immediate follow-up' and '12 months long-term' follow-up. We will use random effects linear and logistic regression models to compare outcomes by randomised arm. The economic evaluation from a societal perspective will take the form of a cost consequence analysis. Data from focus groups and interviews with pupils, parents and teachers will be used to increase understanding of how the intervention has any effect and is integrated into normal school activity.
Discussion
The results of the trial will provide information about the public health effectiveness of a school-based intervention aimed at improving levels of physical activity, sedentary behaviour and diet in children.
Trial registration
ISRCTN50133740
doi:10.1186/1745-6215-12-181
PMCID: PMC3158117  PMID: 21781344
5.  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.
doi:10.1136/bmj.g3256
PMCID: PMC4035503  PMID: 24865166

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