Happy Homework 2.0: A Trial of Daily Movement Habits in Scottish Primary School Children Aged 4-8 Years Old

Purpose: The Happy Homework (HH) intervention included homework activities which aimed to improve both activity-related behaviours across the whole day and key dietary behaviours. The physical activity (PA) activities were informed by the World Health Organisation (WHO) recommendations for children aged 5-17 years that most of children's daily activity should be aerobic, and vigorous-intensity activities should be incorporated including activities which strengthen muscle and bone at least 3 times per week. Additional activities encouraged children to break-up sedentary behaviour (SB) by standing or moving, limit recreational screen-time (ST) to no more than 2 h per day, have adequate sleep durations of between 9 and 11 h per night and maintain consistent bed and wake times. The activities did not require any equipment or large spaces and were mapped in-line with the Scottish Curriculum for Excellence (CfE). The development of the HH intervention was informed by Self-determination theory (SDT). The intervention aimed to develop children's motivation to lead healthier lifestyles by meeting their three basic psychological needs: autonomy (i.e., feeling one has choice and is willingly endorsing one's behaviour), competence (i.e., the experience of mastery and being effective in one's activity), and relatedness (i.e., the need to feel connected and a sense of belongingness with others). Satisfying children's three needs has been shown to be predictive of PA participation and positive health behaviours. HH workbooks were provided to children on a Monday, Wednesday, and Friday to encourage habitual involvement in the activities over an 8-week period from February - April 2019 (i.e., Winter - Spring), which included 2 Easter holiday weeks. Additional activities and health promotion reminders were also provided in the workbooks for the days when the child did not receive HH. Parents were required to sign off each activity that they completed with their child which the teachers subsequently recorded in their logbook, to be used as a measure of fidelity. If a child completed the weekly HH activities, their teacher would place a happy face sticker on their HH workbook at the end of each week as a small reward to foster adherence. A pilot study in 9-12 year olds found that Happy Homework was effective in improving children's physical activity and sleep, as well as fruit and vegetable consumption, yet recommendations to improve the interventions efficacy included moving to a digital platform and away from traditional paper-based homework tasks. As such, Happy Homework 2.0 was co-developed as an app-based intervention, with the same goal of improving children's 24-hour movement behaviours. As such, the purpose of this randomised control feasibility trial will be to examine the feasibility, acceptability and efficacy of Happy Homework 2.0 in improving the 24-hour movement of younger children (i.e., 4-8 years old). Justification: Canada first published 24-hour movement guidelines for children in 2016, followed by New Zealand and Australia in 2017. These guidelines emphasize the importance of higher levels of PA and sleep, alongside lower levels of SB, for optimal health. Despite growing evidence, the United Kingdom (UK) has not yet developed or adopted 24-hour movement guidelines for children. In the UK, only 8% of children meet all three movement guidelines, while 11% meet none. This highlights a clear gap between recommended behaviours and children's actual movement patterns, yet research exploring 24-hour movement guidelines within the UK remains limited. The home environment may play an important role in promoting 24-hour movement, as children spend roughly half their day at home, and parents have been shown to positively influence children's PA, SB, and sleep. While school-based interventions are commonly used to encourage these behaviours, a recent review found that school-based interventions incorporating homework significantly improved children's sleep and reduced sedentary behaviour. Longer interventions were also associated with increased PA. These findings suggest that future school-based programmes should include homework components that target reductions in SB and improvements in sleep. Happy Homework is a school-based intervention designed to promote adherence to 24-hour movement guidelines and help prevent non-communicable diseases. The programme requires no special facilities or equipment, making it accessible to all children regardless of socioeconomic status. The intervention has shown success in improving PA (e.g., stepping time) and sleep in primary school children aged 9-12 years. However, it has not yet been adapted or tested for younger primary school children aged 4-8 years. Research clearly shows that physical inactivity tends to increase as children grow older, especially during the transition into adolescence. Therefore, intervening earlier may prevent this decline before sedentary habits become established. With UK children failing to attain positive 24-hour movement behaviours, and Scottish children being amongst the most inactive globally, development of scalable interventions, which show success, such as Happy Homework, is warranted. Design: This mixed-methods study will include a maximum of 2 co-design workshops which will inform the randomised feasibility trial we will undertake. Stakeholders included in the study will be: * Primary school head teachers and classroom teachers * Parents of children attending school * School children. An iterative co-design process with 4-8 year olds will be used to refine the existing co-produced app. This protocol was developed in accordance with the SPIRIT 2013 Statement and reporting will follow the CONSORT extension for pilot and feasibility trials. The study will be registered on ClinicalTrials.gov prior to participant recruitment. Methodology: Participants who provide both parental consent and child assent will be invited to take part in the study. To maintain study integrity and minimise contamination, schools and participants will be allocated to either the co-design workshops or the randomised feasibility trial study, but not both. A maximum of three connected co-design workshops, and one co-production workshops with each of the 3 different stakeholder groups (i.e., parents, children and teachers/head teachers) will be conducted. The co-design workshops will involve the following: (1) stakeholders reviewing paper-based, low-fidelity prototypes of the HH app; (2) stakeholders providing feedback on the existing design (informed by ongoing study); (3) stakeholders engaging in individual/group design with blank wireframe templates provided (a process referred to as 'feature prioritisation') with their own ideas and features; (4) the 'feature prioritisation' from each workshop informing the proceeding round of co-design; and (5) consolidating the best ideas into a final design that represents a minimal viable product design (a product developed with sufficient features for those involved in early testing) which will be represented through online wireframes. The co-design workshops will be conducted in person. Workshop guides will build upon previous findings within the workshop before each, but will involve the following: (1) stakeholders reviewing an online wireframe of HH app; (2) stakeholders providing feedback on the design and perceived usability (which will be informed by co-design workshops); (3) stakeholders engaging in individual/group design with blank wireframe templates with changes or edits they suggest to change within the online wireframes (feature prioritisation); and (5) consolidating the best ideas into a final design that represents a minimal viable product design (a product developed with sufficient features for those involved in early testing). All workshops will be conducted within the school setting as detailed in the risk assessment, providing a familiar and supportive environment for children. Adult participants (e.g., teachers) will be encouraged to attend in person, although an online option will be made available where necessary. Workshops will be audio-recorded using a university-issued device and transcribed verbatim for analysis. During the feasibility RCT, children will be measured at two time-points: pre-intervention (1 week prior to intervention delivery) and post-intervention (1 week after the intervention). The included cluster-RCT measurements which will be taken include: Demographic information - home postcode, child's eligibility for free school meals, parental/guardian occupation, household annual combined income, highest education qualification achieved by parents/guardian, family status, and number of children living at home will be obtained. The gender of each participant will be obtained to measure gender homogeneity in our sample. Body mass- The height and weight of agreeing children will be collected to allow for the classification of Body Mass Index. Alternatively, children will be provided will the opportunity to self-report their height and weight. Weight will be measured barefoot to the nearest 0.1kg with an electronic scale (university supplied) while height will be measured barefoot to the nearest 0.1cm using a stadiometer in accordance with standard procedures. Additionally, children will be fitted with accelerometer devices which must be worn for the duration of the week prior to intervention delivery and 1 week after intervention delivery. Full details of the devices will be shared will children and parents in an information sheet, including general upkeep, what do to if they fall off, and contact details for the primary researcher for further questions. During both the measurement periods, individuals will be encouraged to resume normal activity. The included devices are as follows: PA - The ActiGraph GT3X will be used to measure the PA levels of children. This device detects accelerations in three axes (i.e., vertical, Mediolateral, and anteroposterior). Prior to data collection, parents, teachers, and children will be instructed on the positioning of the accelerometer (i.e., non-dominant wrist) and advised that the accelerometer should be worn for 7 days over the full day (24-hours), except during water-based activities (e.eg., showers or swimming). SB - The activPAL 3TM monitors will be used with placement on the participants right thigh, midway between the anterior superior iliac spine and the knee, using a hypoallergenic Hypafix dressing. This device uses accelerometer-derived information about thigh position to determine the start and end of each period spent sitting/lying, standing, and stepping, as well as stepping speed, step counts, and postural transitions. This device will be worn for 7 days (24 hours) and will be made waterproof by the dressing; therefore, it can be worn during water-based activities. Sleep - The activPAL 3TM monitors (thigh placement) will be used and has been validated for use within children, with a 24-hour wear time supporting estimates of sleep duration. The 'primary lying' outcome, derived from the activPAL software, will be used by the CREA (version 1.3) and GHLA (version 2.2) algorithms to estimate sleep time duration. The device will be placed on the right thigh, midway between the anterior superior iliac spine and the knee, using a hypoallergenic Hypafix dressing. This device will be worn for 7 days (24 hours) and will be made waterproof by the dressing; therefore, it can be worn during water-based activities. The randomised feasibility trial will involve four primary schools in South Lanarkshire (two intervention and two control), with two classes from each school recruited to participate. Findings from the co-design workshops will inform key aspects of the intervention, including the nature and frequency of homework tasks. The intervention will run for a minimum of 8 weeks and a maximum of 12 weeks. Outcome measures will be collected at two time points: baseline (one week prior to intervention delivery) and post-intervention (the week immediately after the intervention is completed). The primary researcher will familiarise themselves with each school's safeguarding procedures and identify the designated child protection officer prior to study commencement. Although the study is not expected to elicit sensitive disclosures, any concerns arising will be reported to the relevant child protection officer in line with safeguarding protocols. The primary researcher has experience in both qualitative and quantitative methods and holds current PVG clearance for work with children. They will ensure adherence to ethical guidelines throughout, including the rights and welfare of the child.