Title: A cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the GoActive programme to increase physical activity among 13-14 year-old adolescents
Funder: Department of Health and Social Care

Abstract: Background: Adolescent physical activity promotion is rarely effective, despite adolescence being critical for preventing a steep physical activity decline. Low adolescent physical activity is likely to last into adulthood, increasing health risks. Intervention development: The GoActive intervention is evidence-based and designed iteratively with adolescent input to ensure appeal for all students. Strategies for effective inclusion of inactive/shy adolescents were developed in collaboration with people with these characteristics. Feasibility/pilot work: We studied the feasibility in 1 school and conducted a subsequent pilot RCT in 3 schools (2 intervention/1 control). Learning from both projects have been incorporated in the current proposal. Design/setting/target population: Secondary school based cluster randomised controlled trial, recruiting all Year 9 students in participating schools. Intervention being evaluated: GoActive aims to increase physical activity through increased peer support, self-efficacy, self-esteem and friendship quality, and is implemented using a tiered-leadership system. Tutor groups choose 2 weekly activities each; mentors (older adolescents in the school) and weekly peer-leaders (2 per class) encourage students try these. Students gain points for trying new activities; points are entered into a between-class competition. GoActive will run for 2 terms: weekly facilitation support from a council-funded health trainer will be offered in term 1, with more distant support in term 2. Evaluation: We aim to recruit 16 schools with socio-economic status representing national variability. Outcomes assessed at (1) baseline, (2) interim (wk6), (3) post intervention (wk14-16), and (4) 10-month follow-up [main outcome]. Primary outcome: Change in daily accelerometer-assessed moderate-to-vigorous physical activity Secondary outcomes: 1. Accelerometer-assessed sedentary, light, overall physical activity during school time, weekday evenings, weekends 2. Self-reported physical activity, self-efficacy, self-esteem, peer support, friendship quality, mood, school-reported absence and academic performance, measured body fat %, BMI 3. Within-trial, long term cost-effectiveness and cost-utility analyses 4. Mixed methods process evaluation assessing a) programme acceptability, uptake, maintenance, and dose; and b) putative moderators/mediators Sample size: We require 1310 adolescents (N=100/school) for 85% power to detect a 5-minute difference in change in MVPA/day (SD:17.8; ICC:0.034). We aim to recruit 150 participants at 16 schools to account for 30-40% attrition and school drop out. Randomisation: Schools will be randomised after baseline measurements; students will be the unit of analysis. Economic evaluation: Within-trial cost-effectiveness will be expressed as incremental costs per incremental change in physical activity (METs). Long term cost-effectiveness will assess whether the intervention is likely to increase length and/or quality of life, and at what cost. Process evaluation: Focus groups and interviews (mentors/teachers/students) will explore programme acceptability, barriers/facilitators, potential mechanisms of effect, population group differences and maintenance. Qualitative data will inform and be integrated with quantitative data (questionnaires/participation logs). Impact: Stakeholder workshops will ensure dissemination of results for optimal public health impact.

Lay abstract: AIMS This project aims to establish the effect of the GoActive intervention in increasing daily levels of physical activity in 13-14 year-old (Year 9) adolescents. It also aims to measure its cost-effectiveness, and explore why the intervention did or did not work. BACKGROUND - Too little physical activity among young people raises the risk of obesity, mental health problems and poor bone development. - Physical activity levels drop during adolescence and stay low in adulthood, increasing the risk of long-term health problems, such as diabetes and cancer. - To help young people increase their activity level, we have worked with students and teachers to design the GoActive programme. GoActive aims to include all students, whether they are currently active or not. GOACTIVE PROGRAMME - In GoActive, each tutor group chooses 2 different activities each week. Students are encouraged to try these activities by GoActive Mentors (from older Years) and GoActive Peer Leaders (in each Year 9 class). - Students win points for trying new activities, which are also entered into a between-class competition. Prizes are awarded to those reaching individual goals (such as 20 points), and to the classes scoring the most points in a week. - In 2013 we successfully tested GoActive in 3 secondary schools to see how acceptable the intervention was to those involved. This application is based on this experience as well as student and teacher feedback. PROJECT DESIGN - To test GoActive, we will recruit a diverse sample of schools in Cambridgeshire, 8 to run the programme and another 8 to provide a comparison (a randomised controlled trial). We will recruit 150 Year 9 students at each school (2400 in total). - We will compare the activity levels of Year 9 students at schools running GoActive with those at schools not running it. We will compare activity levels while GoActive is running and also when it is finished. - We will measure physical activity using a monitor similar to a pedometer. Also, height and weight will be measured and questionnaires will ask students about the types of activity they do, social support, and mood. We will also review how many students take part, how much it costs, plus students’ attendance and test scores. - During and after the programme we will interview students, Mentors and teachers in discussion groups to see what they think about GoActive. We will also explore how and why GoActive did (or did not) work and if this differs for different people. INVOLVING STUDENTS, PARENTS AND TEACHERS - Involving those who will be involved in GoActive is important to the success of the project. Therefore, throughout the project, we seek feedback on our plans from students, parents and teachers. - We will hold workshops with parents, teachers, school governors and people working in local and national government. Initially, these workshops will focus on making sure that this research provides answers to the questions that matter. Towards the end, we will discuss future use and potential roll-out of GoActive, including the ways of communicating the results to the right people. GETTING THE WORD OUT - The project findings will be presented to students, parents, teachers, and people in local and national government. This will help get the project delivered in more schools across the country. - We also plan to present the work to other academics, through journal publications and presentation at conferences.

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