A multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK)

Background: Obesity levels in children as they start primary school with prevalence increasing with deprivation. Only 10% of 2-4 year olds in the UK meet the recommendation of being physically active at least three hours per day. Most children do not eat sufficient fruits and vegetables, and energy intake from non-milk extrinsic sugar consumption is more than double the recommended amount. Most 3-4 year-olds in the UK attend some formal childcare. These settings provide opportunities to deliver interventions at the population level to improve nutritional quality and physical activity. The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA. We conducted a feasibility study to develop this intervention for use in the UK and found it to be feasible and highly acceptable to nursery staff, health professionals and parents. Aim: To evaluate the effectiveness and cost-effectiveness of the NAP SACC UK intervention to increase physical activity, reduce sedentary time and improve the quality and quantity of nutritional intake. Methods Design: Multi-centre cluster RCT with embedded process and economic evaluations. Participants: UK nurseries; children aged 2-4 years attending an average of 12 hours per week. Intervention: Nursery managers work with a health professional (Partner) to self-assess policies and practices relating to physical activity and nutrition. Nursery staff attend physical activity and nutrition training workshops and set goals to be achieved within six months. The Partner provides on-going support throughout this period. After six months, progress is reviewed, staff receive one further workshop and new goals are set, with on-going Partner support. Comparator: Usual practice Sample: 56 nurseries stratified by region and level of deprivation, randomly allocated to intervention or control. Primary outcomes: accelerometer assessed mean total activity time on nursery days; average calories consumed across all eating occasions on nursery days. Secondary outcomes: Accelerometer assessed mean daily moderate to vigorous physical activity time and sedentary time per nursery day; average size (calories) of food served across all eating occasions in nursery per day; average grams of core and non-core food and the ratio consumed across all eating occasions in nursery per day; zBMI; proportion of children who are overweight/obese; Environment and Policy Assessment and Observation (EPAO) UK Instrument score; child quality of life; cost-effectiveness. If the intervention is found to be effective, we will apply for funding to measure some or all outcomes over a longer period. An embedded process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will assess cost-effectiveness. Timeline: 3.5 years with the intervention running for 12 months. Impact and dissemination: An engagement plan will be produced with collaborators and the Lay Advisory Group. Participants will be informed of the findings through local meetings and briefing summaries. We will disseminate findings to public health, early years and local authority colleagues and the wider scientific community via meetings, articles in practice newsletters, scientific articles and conferences. If the intervention proves effective, we will work with stakeholders to develop a scalability plan.