Title: 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)
Funder: Department of Health and Social Care

Abstract: Background: In the UK, most children under 5 years do not get enough physical activity and many also have a poor diet. As a result, more than one in five children are overweight or obese by the time they start primary school. Many children attend nurseries for childcare, but not all nurseries provide healthy environments. This study will test whether a programme called NAP SACC UK (Nutrition and Physical Activity Self Assessment for Childcare) can improve children’s health by making nurseries a place where children can be physically active and eat healthy food. In a pilot study of NAP SACC UK, we found that nursery staff, parents and health staff liked the programme and the methods we used. This new, larger study will now test whether NAP SACC UK improves children’s physical activity, food intake and obesity levels. We will also test whether it is a good use of money._x000D_ The programme: The NAP SACC programme has five parts. 1. Nursery managers work with a health professional (called a Partner) to assess what they currently do to promote physical activity and healthy eating. 2. Nursery staff attend training workshops in their own nursery. 3. Nursery staff set goals to be achieved in the next six months. 4. The Partner gives on-going advice and support during this period. 5. After six months, the Manager and Partner look at what changes have been made, and set new goals for the next six months. _x000D_ _x000D_ Methods: We will recruit 56 nurseries from four areas of the UK. Children aged 2-4 years who go to nursery for an average of 12 hours per week will be invited to take part. Half of the nurseries will take part in the NAP SACC UK programme, while the other half will continue as normal. Whether they take part in the programme will be decided randomly, like tossing a coin. _x000D_ _x000D_ Before we start the programme and one year later we will: measure each child’s height and weight; ask them to wear an activity monitor (accelerometer); and take photographs of everything they are served and eat at nursery snack and mealtimes to estimate how much food they eat. We will see if children in the NAP SACC UK group haver better physical activity levels, nutrition and obesity levels than children who did not receive the programme. If we see a positive difference we will apply for funding to take some or all of these measurements again later to see if the changes last._x000D_ To check how the programme is run, we will observe staff workshops and interview nursery managers and Partner” to understand how the programme was delivered, any problems there were and in what ways it has been helpful. We will also work out how much the NAP SACC UK programme costs and weigh this against any benefits to decide if it provides value for money. _x000D_ _x000D_ PPI: During the pilot study the NAP SACC UK programme and methods were shaped through discussion with parents, nursery staff, and education and health staff. We will continue to meet with this group to help us to communicate and engage with nursery staff and parents before, during and after the study._x000D_ _x000D_ Dissemination: We will tell the people who took part in the study what we found out through local meetings and written summaries. We will present the findings to people working in public health, local authorities and childcare settings, through written reports and presentations at scientific conferences. If NAP SACC UK is effective at improving child health, we will talk to local authorities about how to deliver it in other UK nurseries.

Lay abstract: 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._x000D_ _x000D_ 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._x000D_ _x000D_ Methods_x000D_ Design: Multi-centre cluster RCT with embedded process and economic evaluations._x000D_ _x000D_ Participants: UK nurseries; children aged 2-4 years attending an average of 12 hours per week._x000D_ _x000D_ 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. _x000D_ _x000D_ Comparator: Usual practice _x000D_ _x000D_ Sample: 56 nurseries stratified by region and level of deprivation, randomly allocated to intervention or control._x000D_ _x000D_ Primary outcomes: accelerometer assessed mean total activity time on nursery days; average calories consumed across all eating occasions on nursery days._x000D_ _x000D_ 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. _x000D_ _x000D_ If the intervention is found to be effective, we will apply for funding to measure some or all outcomes over a longer period._x000D_ _x000D_ An embedded process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will assess cost-effectiveness._x000D_ _x000D_ Timeline: 3.5 years with the intervention running for 12 months._x000D_ _x000D_ 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.

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