Title: Active For Life Year 5: A cluster randomised controlled trial of a primary school-based intervention to increase levels of physical activity decrease sedentary behaviour and improve diet
Funder: Department of Health (England)

Abstract: Design: School-based cluster randomised controlled trial. Setting: State primary and junior schools with Year 5 children (aged 9-10) in the city of Bristol. Special schools will be excluded. Participants will be Year 5 children in these schools whose parents provide opt-out consent. Children will only have measurements if they provide assent.Target population: UK school children aged 9-10Intervention: Schools randomised to the intervention (N=30; 750 children) will receive the intervention immediately and those randomised to control (N=30;750) after completion of the 2-year follow-up assessment. The intervention comprises: a) training for classroom teachers; b) provision of 16 lesson-plans and teaching materials including pictures CDs and journals; c) provision of 10 parental-child interaction homework activities (see detailed project description); d) information in the school newsletters about the importance of increasing physical activity reducing sedentary behaviour and improving diet; e) written information for parents on how to encourage their children to eat healthily and be active; f) a healthy activity day at school for parents teachers and children in the middle of the intervention period. Training for classroom teachers will take place over 1 day (as in the feasibility/pilot studies) and will be provided by the two teacher trainers who provided training for our feasibility/pilot studies together with input from the applicants and the trial coordinator. At the end of the training the teachers will be provided with lesson plans and all necessary materials for the 16-lessons and 10 homework activities as well as contact details of the trial coordinator. Measurements of Outcome and Duration of follow-up: All outcomes will be assessed at baseline (prior to starting the intervention); 1 year later (at the end of the intervention) and 2 years later (to assess any long term impact). All three assessments will be conducted at the same time of year and will be completed by two trained fieldworkers. At each stage of assessment the following will be measured on the children:1. Accelerometer assessment of physical activity and sedentary behaviourWe will use an ActiGraph accelerometer and will use the same protocol to that used in our feasibility/pilot work. The accelerometers will be shown to the children and verbal instructions provided in the class room with all children together. Data will be collected on three weekdays and both weekend days. The accelerometer data will be downloaded and analysed using standard protocols to define sedentary light moderate and vigorous levels of activity. 2. Weight height and waist circumferenceAll anthropometric measurements will be completed with each child in a private room. Weight (to the nearest 0.1kg) will be measured without shoes in light clothing on a Seca digital scale. Height will be measured to the nearest 0.1cm without shoes using a portable Harpenden stadiometer. Waist circumference will be measured the nearest 1mm at the mid-point between the lower ribs and the pelvic bone with a flexible tape. 3. Questionnaire assessment of diet physical activity and sedentary behaviourAll questionnaires will be combined into one document and administered in the classroom with the two fieldworkers present to answer any queries. Fruit and vegetable consumption and other dietary outcomes will be assessed using the “A Day in the Life Questionnaire” (DILQ) which was used in our feasibility/pilot studies and has been previously validated in children of this age. Fruit and vegetable consumption will be assessed using an established scoring scheme. The DILQ data will also be used to create categories of snacks high fat food and high energy drink. As in the pilot study allocation of foods written in text to categories will be undertaken independently by two individuals with discrepancies checked by the trial coordinator. An abbreviated and updated version of a previously validated screen viewing questionnaire that was used in our feasibility/pilot study will be used . The questionnaire asks about the length of time spent doing screen based activities on the previous weekday and Saturday. Validated (in children of this age) questionnaires for assessing children’s self-efficacy to change physical activity and fruit and vegetable consumption behaviour and for assessing parental support of change in these activities in their children will be used to assess our mediators.4. Collection of information on costs: Intervention related resource use in the form of time and travel will be collected through researcher and teacher time logs. Parental time and other expenses will be collected through brief self completed questionnaires completed by parents twice (mid-point and end) during the intervention period. Researchers will also record non time resources used in the provision of lesson plans teaching materials and parental informationSample Size: The pilot study provided information for this calculation including intracluster correlation coefficients (ICC). With 60 schools (~1500 pupils) we will be able to detect effects that would be of public health importance (0.25-0.30SD for each outcome) with 80-90% power at a 0.05 alpha level for all primary outcomes and similar levels of power at a 0.01 alpha level for secondary outcomes. Analyses: Analysis and presentation of data will be in accordance with CONSORT guidelines with the primary comparative analysis being conducted on an intention-to-treat basis and due emphasis placed on confidence intervals for the between-arm comparisons. For continuously measured outcomes we would use multivariable linear regression and for binary outcomes logistic regression. The economic evaluation from a societal perspective will take the form of a cost consequence analysis. Resources will be valued as reported by researchers teachers and parents and using routine data sources. Random-effects regression will be used to account for clustering by schools in all analysesTime-table: The study will be completed in 3.5 years. All schools will be recruited prior to random allocation. Baseline assessment will take place during the first 8 months. Schools (N=30) allocated to intervention will have the intervention during the first 1.5 years. Follow-up assessments will be at 1 and 2 years post baseline assessment and the final 6 months of the study will be used to complete all analyses and papers for publication.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL