Title: Action 3:30: A cluster randomised feasibility study evaluation of a teaching assistant led, extracurricular physical activity intervention for 8 to 10 year olds
Funder: Department of Health and Social Care

Abstract: Design: Feasibility study. Schools randomised to Action 3:30 or usual provision. Participants: 360 Year 4/5 pupils from 12 primary schools. Recruitment: Prior to recruitment we will collect self-reported physical activity data in 8 schools and accelerometer plus self-reported activity in 4 schools. Then, in 6 schools we will employ recruitment method A. In the other 6 schools we will run recruitment method B which will have taster sessions during PE classess as an additional component. To enhance external validity, a second enrolment for intervention children will be offered. Intervention: Intervention schools will receive the Action 3:30 intervention. Action 3:30 is a 5-day programme that trains Teaching Assistants (TAs) in how to deliver physical activity sessions. TAs then deliver 30, 1-hour sessions after-school. Outcomes: Measures will be assessed prior to randomisation (T0) and during the last 6 sessions (T1). Main outcomes will be acceptability of the recruitment and study design and feasibility of increasing boys and girls Weekday MVPA. The primary outcome in a future trial would be weekday MVPA at T1. Economic evaluation: The KIDSCREEN-10 and CHU9D will be piloted as a health-related quality of life outcomes. Intervention-related resource use will be collected and a survey will be completed in all schools to assess after-school club costs. Process evaluation: We will conduct a process evaluation to provide insight into the extent to which the intervention was delivered as planned and facilitate a RE-AIM evaluation of potential population impact. TAs will record session attendance and adherence. Research staff will observe 3 sessions per school to assess fidelity. We will conduct 12 child focus groups in intervention schools, interview all TAs (n = 12) and key contacts (n = 12). We will examine factors that might have affected recruitment, delivery, attendance, enjoyment, anything that could be improved, potential contamination and any inequalities that might affect future delivery and any logistical issues with the opt-out consent process. Analysis: Eligibility, recruitment and follow-up figures will be presented as a CONSORT chart. Participant characteristics (BMI and activity) will be descriptively compared for participants recruited via the two different approaches and children recruited from the second enrolment. Change in mean activity over the intervention period, and the whole follow-up period will be presented with 95% CIs for the intervention and control schools separately, and further divided to present the findings for girls and boys separately within the two study arms. We will conduct a secondary analysis in which we will pilot the use of a complier average casual effect (CACE) analysis in which the data from all potential students in the 4 schools is used to model the effect of receiving Action 3:30 on MVPA. Mean changes and variation in KIDSCREEN and CHU9D health related quality of life scores will be estimated at the school level. Cost data will be analysed to estimate variation in the cost of implementation at the school level in a definitive trial. We will assess all RE-Aim dimensions to estimate the potential population impact of Action 3:30 in a full trial. Potential impact: If progression criteria are met we will apply for further funding. Funding: Intervention costs are funded by South Gloucestershire & North Somerset Councils

Lay abstract: Active children are more likely to have better physical health and feel better. The government recommends that all children should do an hour of physical activity that makes them feel slightly out of breath and sweaty each day. Many children do not meet this guideline. Primary school is when children establish physical activity behaviours and the skills they need to be active. The after-school period is a time in which children can be active but what schools currently provide is mainly team sports. Team sports do not appeal to less active children, who often do not feel able to join in. Instead, schools need after-school activity clubs that focus on having fun, taking part and trying new skills which are affordable. Teaching Assistants (TAs) are school staff members who could be trained to deliver physical activity clubs after-school, which would be a low-cost, sustainable public health intervention. We have developed a programme to help Teaching Assistants (TAs) deliver a fun physical activity programme, called Action 3:30. In Action 3:30, Teaching Assistants receive a 5-day training programme. Once trained, the TAs deliver enjoyable activity clubs for Year 4-5 children for an hour, twice a week. We recently completed a study, which showed that Action 3:30 is well liked by pupils and TAs. Attending Action 3:30 made boys more active but not girls. The study also showed that we recruited children who were already quite active. Guided by experts, we have changed the project to ensure that both boys and girls like it. We have changed session plans, and created videos of example sessions. We have also chosen a new recruitment approach in which children go to a taster session which shows them what the afterschool club would be like. Children and their families are told the days the club will run at the start, so that they know what they are committing to. We want to test if this new approach results in more low active children signing up and sticking with the programme. We want to test how acceptable our recruitment methods are to children and what they think about the changed intervention. We also want to find out the effect of the club on boys’ and girls’ physical activity and see if we need to make more changes to the project before we do a bigger study in more schools. We will conduct a school-based randomised controlled feasibility study in 12 primary schools. We will recruit 30 Year 4/5 children from each school. We will test two new recruitment methods (a and B) with half the schools receiving A and half B. Both approaches will include working with teachers, parents and children but B will also provide taster sessions during PE lessons.We will then look at how schools respond to the two different approaches and if there are any differences in the participants that sign up. Once signed up, we will ask all children to answer a survey and wear an accelerometer, which is a small device that records physical activity. We will train the TAs to deliver the clubs in six of the schools. The other schools will continue as normal. We will talk to the children, TAs and school staff to report what they thought about the programme and ask what they would change. We will assess all RE-AIM dimensions to estimate the potential population impact of Action 3:30 in a full trial and identify any changes to the intervention or study design or evaluation that would increase the likelihood of the intervention being nationally implemented

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