Child-care self-assessment to improve physical activity, oral health and nutrition for 2- to 4-year-olds: a feasibility cluster RCT

Article history

The research reported in this issue of the journal was funded by the PHR programme as project number 12/153/39. The contractual start date was in April 2017. The final report began editorial review in February 2018 and was accepted for publication in September 2018. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PHR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Ruth Kipping received grants from North Somerset Council and Gloucestershire Council. Ruth Kipping and Rona Campbell received grants from Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer). Laura Johnson received grants from the Elizabeth Blackwell Institute (University of Bristol) and the Wellcome Trust. Laurence Moore received grants from the Medical Research Council (MRC) and from the Scottish Government Chief Scientist Office. Rona Campbell (2015–current), Laurence Moore (2009–15) and Russell Jago (2014–current) were members of the National Institute for Health Research (NIHR) Public Health Research (PHR) Research Funding Board. William Hollingworth was a member of the NIHR Health Technology Assessment Clinical Evaluation and Trials Board. Rona Campbell was a member of the MRC Public Health Intervention Development (PHIND) Scheme Funding Board and the Board of DECIPHer Impact.

Copyright statement

© Queen’s Printer and Controller of HMSO 2019. This work was produced by Kipping et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

2019 Queen’s Printer and Controller of HMSO

Preschool children’s physical activity, nutrition and weight: a national priority

In England, 22.6% of children starting primary school are overweight or obese. 2 Obesity rates increase with deprivation; 12.7% in the most deprived areas are obese, compared with 5.8% in the least deprived decile. It is predicted that 17% of children aged 2–11 years in England will be overweight in 2020 and a further 13% will be obese. 3 Therefore, it is a priority that interventions are developed, tested and implemented with preschool-aged children to reduce their risk of developing obesity and chronic diseases.

Among children, physical activity (PA) is associated with lower levels of cardiometabolic risk factors, including blood lipids, blood pressure and improved psychological well-being. 4 Patterns of PA track moderately from childhood to adulthood, suggesting that it is linked to both short- and long-term health among children. 5 Furthermore, review evidence has identified that preschool children (aged 3 to 4.9 years) who had higher levels or increased amounts of PA were associated with improved measures of adiposity, motor skill development, psychosocial health and cardiometabolic health. 6

The English Chief Medical Officer’s recommendations are that children < 5 years of age who are capable of walking should be physically active for at least 3 hours per day and sedentary time should be minimised. 7 There is no guidance about screen time in the UK. In 2012, only 10% of 2- to 4-year-olds in England were classified as meeting the current guidelines for children < 5 years7 of at least 3 hours of PA per day. In addition, 3- to 4-year-olds in the UK are sedentary for an average of 10–11 hours per day. 7,8

A diet that is high in fruit and vegetables and low in saturated fat has been associated with reduced risk of many forms of cancer, adult heart disease and all-cause mortality. 9 Dietary patterns are often set during childhood. Children aged 1.5–10 years in the UK do not eat sufficient amounts of fruit and vegetables, and 32% of boys and 18% of girls are reported as having eaten no fruit during a 4-day period. 10 The latest national recommendation is that intake of free sugars should provide no more than 5% of total energy intake for adults and children aged > 2 years. 11 Intake of non-milk extrinsic sugars (NMES) is 12% of total daily energy intake for 1- to 3-year-olds and 13% for 4- to 10-year-olds. 12 Soft drinks contribute 10% to the intake of NMES in 1- to 3-year-olds and 13% to the intake of NMES in 4- to 10-year-olds. Saturated fat intake is also higher than the recommended 11% of total daily energy intake, at 14.6% for 1- to 3-year-olds and 13.3% for 4- to 10-year-olds. Preschool-aged children in low-income populations are more likely to consume table sugar and soft drinks than those in more affluent groups. 13

A study of the prevalence of dental caries among a sample of 5-year-old children in state-funded schools in England found that 24.7% of children had some obvious tooth decay in 2014/15. 14 The average number of teeth that were decayed, missing or filled in the whole sample was 0.8, and among those with decay it was 3.4. There is a clear correlation between higher deprivation and dental decay (R² = 0.47) at local authority level. Poor oral health can have a negative impact on sleeping, eating, speaking, playing and socialising for children. 15 Furthermore, it is the most common reason for admission for hospital in children aged 5–9 years in England. 16 A Public Health England commissioning toolkit for oral health reviewed the evidence for a wide range of oral health interventions and found that there was some evidence for the effectiveness of healthy food and drink policies in early childhood settings and recommended this approach. 17 Furthermore, the review found that oral health training for the wider professional workforce appeared promising although there was a lack of randomised controlled trials (RCTs).

Three systematic reviews of obesity prevention, PA and nutrition in young children each identified a lack of studies in young children and a clear need for more research with robust study designs. 18–20 The 2011 Cochrane review of obesity prevention in children identified research gaps for effective interventions for children aged 0–5 years. 20 In addition, this review recommended that studies must better report the impacts on the environment, setting and sustainability. Studies should also test interventions that are guided by theory-based frameworks such as the socioecological model.

Rationale for a feasibility study on physical activity and improved nutrition in child-care settings

Child-care settings provide opportunities to deliver interventions at the population level. 21 Ninety-seven per cent of children aged 3–4 years in England attend some form of government-funded early years education, of whom 39% attend day-care providers outside school settings. 22 In England, government-funded child care for 3- and 4-year-olds increased from 15 to 30 hours/week in September 201723 (with certain conditions on parental employment), which has the potential to increase the amount of time children spend in child-care settings. However, not all child-care settings are health-promoting environments. Child-care settings provide scalable opportunities to deliver interventions at the population level. 21 The 2012 Early Years Foundation Stage (EYFS) statutory framework sets the standards to ensure that children learn, develop and are kept healthy and safe. 24 The EYFS includes somewhat limited standards for PA and healthy diet and requires nurseries to maintain a high staff to child ratio (1 : 4 for 2-year-olds, and 1 : 13 for 3- to 5-year-olds). 24 This provides nursery staff with contact during mealtimes to apply the techniques of taste exposure, encouragement, praise, and modelling of healthy eating. Furthermore, the settings can constrain or enable PA. A systematic review of the role of peers in eating behaviours and PA found that there was some evidence to support the role of peers. 25 Four out of the six PA studies reported that children were more active when peers were present. However, large peer group size was negatively associated with PA in two cross-sectional studies. 26,27 All nutrition interventions in the review reported that children’s eating behaviours may be influenced by their peers.

The Children’s Food Trust published voluntary guidelines for food in early years settings in 2012. 28 In addition, PA guidelines for young children in England were published in 2011. 7 The English 2016 Childhood Obesity strategy is very limited with respect to preschool children,29 but local authorities in England and Wales are increasingly developing and implementing their own programmes to support healthy interventions in early years settings. We have reviewed the local authority websites for the Core Cities in England and found all (except one) have some form of healthy early years programme. In Wales, the Healthy and Sustainable Pre-School Scheme was started in 2011 on seven health topics: Nutrition and Oral Health; Physical Activity/Active Play; Mental and Emotional Health, Wellbeing and Relationships; Environment; Safety; Hygiene; and Workplace Health and Wellbeing. 30 These programmes all include nutrition and some have additional health topics. However, none of these programmes has been evaluated for effectiveness through a RCT. Therefore, new approaches are required to prevent obesity and reduce inequalities in early years settings.

Assessment of PA in 3- to 5-year-old children at preschool has shown that they are physically inactive during most of their time in preschool, with only 3% of time engaged in moderate to vigorous physical activity (MVPA). MVPA is closely associated with cardiorespiratory fitness and body mass index (BMI) in adolescence; therefore, it is of concern that such a small proportion of time in preschool is spent in MVPA. Furthermore, about 80% of time is spent in sedentary activities. 31 However, studies have found different levels; one study found that children aged 3–4 years in the UK (in particular boys) spent more time in MVPA and were less sedentary when in child care than when at home. 32 The particular preschool that a child attends is a strong predictor of PA levels, and being outdoors is one of the most powerful correlates of PA in children. 31 The lack of MVPA in preschool settings may be influenced by space constraints, a lack of equipment, a lack of policies and a lack of scheduled times for free play and outdoor play and a lack of staff training in PA promotion. 19 A systematic review of interventions to increase PA in child-care settings concluded that regularly provided, structured PA programmes can increase the amount and intensity of PA undertaken. 33

Larson et al. 18 reviewed the regulations, practices, policies and interventions for promoting healthy eating and PA and for preventing obesity in children attending child care. The review identified a lack of strong regulation in child-care settings in relation to health behaviours, such as PA and diet. A 2016 Cochrane review of strategies to improve healthy eating, PA and obesity prevention in child-care services found that:

Weak and inconsistent evidence of the effectiveness of such strategies in improving the implementation of policies and practices, childcare service staff knowledge or attitudes, or child diet, physical activity or weight status. Further research in the field is required.

Wolfenden et al. 33

There is ample opportunity within child-care settings to improve nutritional quality, oral health, time engaged in PA and promotion of health behaviours by caregivers. Other than Nutrition And Physical Activity Self Assessment for Child Care (NAP SACC) (see NAP SACC), a small number of RCTs based in child-care settings that aim to improve nutrition and/or PA or sedentary time with 2- to 4-year-olds have been published (Table 1). The studies focused on education, staff development, and addressing child-care policies or opportunities for increasing PA. Many, but not all, of the studies reported small changes in children’s PA, sedentary time or nutrition in the short term. Only one intervention showed an effect on weight. 40 There was a lack of long-term follow-up or demonstration of effect across a wide range of anthropometric and behavioural changes. Only four of the studies were in the UK and none of these targeted both diet and PA within child-care settings.

Ongoing randomised controlled trials

Internationally, several trials in early years settings or with families of preschool children are currently being conducted with the aim of improving nutrition and/or PA, which further demonstrates the importance of improving health for this age group:

• Jump Start is a multicomponent PA intervention for children aged 3–5 years in Australia. The intervention uses lessons in preschool and a home-based component with the primary outcome of total activity (accelerometer measured) during centre hours. 52

• The Healthy Start-Départ Santé intervention is being tested in preschools with children aged 3–5 years in Canada. The intervention aims to enable parents and preschool staff to integrate PA and health eating into the day. 53

• The DAGIS study (increased health and wellbeing in preschool) is a preschool intervention that is being developed with the aim of reducing inequalities in energy balance-related behaviours in preschoolers aged 3–5 years in Finland. 54,55

• In Norway, a web-based programme to reduce food-related fears and promote healthy dietary habits in 1-year-olds is being studied through a trial design with two different interventions. 56

• The physical Literacy in the Early Years (PLEY) Project in Nova Scotia (Canada) is aiming to determine if 3- to 5-year-old children who participate in active outdoor play in Childcare Centres, facilitated by educators trained in embedding loose parts into outdoor play spaces, develop greater physical literacy. 57

• Smart Moms is a 6-month smartphone intervention in North Carolina (USA) that aims to reduce sugar-sweetened beverage and juice consumption among children aged 3–5 years with overweight or obese mothers. 58

• The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend) is a trial in Australia testing a 33-month intervention using web-based materials and Facebook (Facebook, Inc., Menlo Park, CA, USA; www.facebook.com) with parents of infants, alongside the pre-existing six 2-hour sessions given quarterly to first-time parents. 59

NAP SACC

The NAP SACC intervention was chosen to be adapted and piloted in the UK in this study. 60 NAP SACC, which was developed in the USA, is focused on improving nutrition and PA environment, policies and practices in child-care centres through self-assessment and targeted technical assistance. It addresses PA, sedentary behaviours and nutrition by allowing providers to choose where they focus change. The NAP SACC approach, which uses data, evidence-based action-planning, choice, support, engagement and ownership, tailoring and sustained change, has been used in other UK public health interventions. RCTs of NAP SACC in the USA have demonstrated the feasibility and acceptability of the intervention, the effectiveness of improving the environmental audit nutrition score [11% improvement from a baseline Environment and Policy Assessment and Observation (EPAO) score of 8.6],60 increase in nursery staff’s knowledge of childhood obesity, healthy eating, personal health and working with families (all at a p < 0.05 level), decrease in children’s body mass index z-scores (zBMI) (p = 0.02)61 (a measure of relative weight adjusted for child age and sex) and an increase in accelerometer-measured PA by 17% (p < 0.05) and a 46.2% increase in vigorous activity (p < 0.05). 62 NAP SACC was updated in 2014 and the revised online version, called ‘Go NAP SACC’, includes expanded best practices and is the version which NAP SACC UK is based on, excluding the materials for breastfeeding. 63

NAP SACC is one of the few interventions that works with child-care providers to produce sustainable changes in the child-care environment and promote improvements in children’s activity levels and nutritional intake. NAP SACC has been widely adopted throughout the USA, which demonstrates that it is a model that, if shown to be effective, could easily be disseminated in the UK. NAP SACC has not previously been assessed for feasibility or acceptability of use in the UK or with direct measures of nutrition or BMI. In addition, some issues of fidelity to the intervention were encountered in the US trial, which were addressed through this feasibility study.

Study aim and objectives

The aim of the feasibility study was to evaluate the feasibility and acceptability of implementing and trialling an adaptation of the NAP SACC intervention, with a home component in nursery settings. The study had one primary objective and three secondary objectives.

Feasibility study design

The feasibility study had two phases:

• Phase 1: intervention adaptation and development, in which the NAP SACC materials were adapted for use in the UK and the NAP SACC UK home component to involve parents/carers was created.

• Phase 2: feasibility cluster RCT with embedded process evaluation and health economic methods (Figures 1 and 2). The logic model for the NAP SACC UK intervention is shown in Figure 3.

FIGURE 1.

Phase 1 flow diagram.

FIGURE 2.

Phase 2 flow diagram.

FIGURE 3.

Logic model of NAP SACC UK. IOTF, International Obesity Task Force.

The protocol for the study has been published. 1

Progression criteria

The predefined progression criteria for the trial, as agreed with the external Trial Steering Committee (TSC) and the funder [National Institute for Health Research (NIHR)], were the following.

Trial registration, governance and ethics

The study was approved by Wales Research Ethics Committee 3 prior to recruitment and data collection commencing (formative work 14/WA/1134; pilot RCT 15/WA/0043; process evaluation 15/WA/035). The trial protocol was registered with Current Controlled Trials (ISRCTN16287377: www.isrctn.com/ISRCTN16287377). Ethics approval for the mediator questionnaire substudy was obtained from the Faculty of Health Sciences Research Ethics Committee at the University of Bristol (reference 41585). Ethics approval for the nursery food photography feasibility substudy was obtained from the University of Bristol School for Policy Studies Research Ethics Committee in November 2017. The feasibility RCT was overseen by a TSC, comprising an independent chairperson and four independent members. The TSC met approximately 6-monthly throughout the study (with one 12-month gap), meeting five times in total, to examine trial progress, conduct and scientific credibility. This was a pilot trial with no interim analysis and, therefore, the TSC and funder agreed that a separate Data Monitoring and Safety Committee was not necessary.

Safety

Child-care providers were given contact details for the trial manager and were able to contact the study team if they had any concerns or parents/carers report concerns. Nursery managers and those delivering the intervention (health visitors and trainers) were asked to contact the study team within 5 working days if any untoward incident or adverse event (AE) occurred to a member of staff or child, as a direct result of taking part in NAP SACC UK, or because of changes that have occurred in the nursery environment as a result of participation in NAP SACC UK. Study-specific AE/incident report forms were available to be used to record information on the event. No AEs or serious AEs were reported associated with the intervention or trial.

Public involvement

A patient and public involvement group was set up early in the project to provide advice and guidance. Parents, child-care staff, health visitors, local authority early years staff, public health specialists, health improvement staff and a dietitian were invited to participate. The first meeting was held in March 2015, during phase 1 of the project, as phase 2 (a feasibility RCT) was being planned. The topics discussed included the wording of parent questionnaires, wording of the questionnaire around future use of anonymised data, the content and delivery of the nursery staff workshops that made up a key component of the intervention, the home component, ‘NAP SACC at Home’, and suitable thank you gifts for the children involved. This first meeting was well attended (nine lay members). The next meeting, held in February 2016 with the same group invited, was very poorly attended (one lay member). This meeting was held after baseline data collection, prior to the intervention. The main topic for discussion was the home component, ‘NAP SACC at Home’, particularly how to engage parents and children, the suitability of sending tips by text and e-mail, how to encourage parents to set goals, and the use of a NAP SACC UK Facebook group.

The final meeting was held in July 2017 at the end of the study. This time only nursery managers were invited (five attended) and the meeting was used to discuss improvements that could be made to the NAP SACC intervention and data collection methods following issues identified during the feasibility study. Topics discussed included how to approach nurseries and parents to improve recruitment, incentives for nurseries to participate, dietary measures and the possibility of weighing or photographing food consumed by children, intervention delivery and the impact of the government-funded 30 hours of child care due to start in September 2017. This was a very useful meeting with good engagement from nursery managers, who provided useful insights.

Changes made to the protocol and intervention following phase 1

Phase 1 eligibility and recruitment

A purposive sample of eight child-care providers in North Somerset and eight child-care providers in Cardiff were sent a letter inviting the child-care provider staff to take part in a focus group or telephone interview to inform the development of the NAP SACC UK trial. A letter, project information sheet, reply envelope and form indicating if they wish to participate in a focus group or telephone interview were sent. The sample of child-care providers included private day nurseries as well as community preschools and Children’s Centre nurseries but did not include parent-and-child playgroups or crèches. North Somerset and Cardiff were selected because these are the areas where the RCT was originally intended to take place, Gloucestershire was substituted for Cardiff for phase 2. The two areas provided diverse localities within England and Wales, including urban and rural settings, with a range of deprivation and ethnicity indices.

Health visitors in North Somerset, Wales Healthy and Sustainable Pre-School Scheme (WHASPS) staff in Cardiff and early years staff working at local authorities in North Somerset and Cardiff were sent the same information inviting them to take part in separate focus groups. Written informed consent was taken before the focus groups and telephone interviews commenced.

Phase 1 data collection procedures

Twelve (75%) nurseries were recruited, eight in North Somerset and four in Cardiff. The recruited child-care settings were asked to send parents with children aged 2–4 years a letter, project information sheet, reply envelope and form indicating if they wish to participate in a telephone interview to discuss the NAP SACC UK intervention and trial.

Interviews were conducted with parents in sufficient numbers until saturation was reached and followed a semistructured format with follow-up probes on key topics of interest. Questions focused on ways in which the NAP SACC intervention could be adapted to involve parents and methods of maximising participation in the trial. Each telephone interview lasted 30–45 minutes, was conducted by a trained researcher and was recorded using an Olympus DS-2200 Digital recorder (Olympus DS-2200 Digital recorder, 2 Corporate Center Drive, Melville, NY, USA).

Focus groups were initially chosen as the method of data collection for nursery, early years and public health staff. Focus groups are an effective method of collecting qualitative data as the thoughts and ideas of some members of the group can often encourage others to verbalise their responses in a comfortable, safe and supportive environment. 68 Each focus group lasted 45–60 minutes, was conducted by a trained moderator and was recorded using an Olympus DS-2200 digital recorder.

The focus groups had a semistructured design with follow-up probes on key topics of interest. Questions focused on which aspects of NAP SACC needed to be adapted to incorporate UK guidance, recommendations and terminology; how NAP SACC could be adapted to include parents; what additional training could be provided to child-care staff to increase structured active play; how the intervention could be promoted to child-care providers; what factors might influence low participation and adherence to the programme and study; and what strategies should be used to maximise participation.

Owing to the logistical difficulties of arranging focus groups with nursery staff, it was later decided to hold telephone interviews for most nursery staff. The same topic guides were used for the nursery staff interviews as they were for the focus groups and ethics approval was given for the change.

In addition to discussing how NAP SACC could be adapted to the UK during focus groups and interviews, potential changes to NAP SACC were discussed during meetings with a group of local experts, including a community dietitian, oral health and PA specialists, as well as with the study Trial Management Group, the TSC and the founder of NAP SACC (and co-applicant), Dianne Ward.

Phase 1 data analysis

The interview and focus group recordings were transcribed verbatim and anonymised. Tapes were erased and destroyed after transcription. All identifying data were removed from the transcripts. The qualitative software analysis package NVivo (Version 10, QSR International, Warrington, UK) was used to support analysis and data management. As the data were exploratory, a thematic analytical approach was used. A member of the research team indexed a subset of transcript data to construct a coding framework. Codes were then applied to the remaining transcript data. Codes were assembled to construct emergent themes, which were refined and agreed through discussions between the research team. All participant narratives were equally privileged in the generation of new theoretical and empirical insights. Anonymised data were presented in the form of quotes.

Recruitment

Participant characteristics are shown in Table 2. A total of 12 nursery managers, 31 parents and 15 public health and early years staff participated in the study. More than 90% of the participants were female. Four focus groups were conducted with public health and early years staff, along with one focus group for nursery staff. All 31 parents were interviewed by telephone.

Nursery environment

NAP SACC intervention

Nursery staff were asked to look at the questions on the self-assessment form and provide feedback on their clarity, appropriateness and fit with UK standards. They were also asked to comment on the length of the draft document. Overall, nursery staff were positive about the NAP SACC approach of self-assessment:

. . . I thought they were quite . . . reflective and . . . not too off-putting either . . . and you just literally tick boxes, which is what we always like.

Manager_Mid_SES_Nursery_3

You know, when you said 70 questions I thought, ‘Ooh’. But actually they’re quite straightforward.

Manager_High_SES_Nursery_2

However, the absence of a section on oral health in the self-assessment form was noted to be a growing concern in nurseries:

. . . one thing that has come to our attention in nurseries . . . is children’s teeth . . . more so than obesity, I feel. We have three children at the nursery . . . one . . . is 2 years old and her teeth are rotten . . . another little boy . . . has a hole in his tooth . . . another little girl . . . has got holes in her teeth . . . to the point where she needs them out. And I think . . . we need to put . . . oral health in there somewhere.

Manager_Mid_SES_Nursery_3

Regarding the action-planning document, nursery staff suggested reducing the number of goals required to be set over a 6-month period:

I don’t know whether 10 would be manageable in 6 months, besides everything else that people have to do as well. 10 just seems quite a lot. I’ve got action plans that I might have 10 on but I’m going to spend a whole year covering those. 6 months to do 10 is quite a lot I think.

Manager_Low_SES_Nursery_10

We usually have, when we do anything in child care, we usually use three or four goals, targets.

Manager_Mid_SES_Nursery_3

They also welcomed improved links with health visitors:

We never ever see a health visitor, so I think that’s amazing.

Manager_Mid_SES_ Nursery_2

However, health visitors and WHASPS expressed concern over their capacity to deliver training workshops for nursery staff:

My area, there’s lots of health visitors, so we’d probably be able to achieve it. But in other places, like here, [town name], they may not be able to because there’s quite a few nurseries and not many health visitors, so they might struggle to get round each one, with getting their work done as well.

Health_Visitor_North_Somerset

I think having to give presentations maybe takes us into a different level of time commitment.

WHASP_Cardiff

When asked if the proposed workshop topics of ‘childhood overweight’, ‘nutrition for children, ‘physical activity for children’ and ‘personal health and wellness for staff’ would be of interest to child-care staff, nursery managers expressed a particular need for more staff training in children’s PA:

. . . although physical development is now a prime area for us to promote, a lot of us have not had any training about how to promote that, you know, the types of activities, and it’s not easily available.

Manager_High_SES_Nursery_5

However, concerns were raised about the sensitivity of the topic ‘personal health and wellness for staff’:

. . . that could be quite a tricky area, couldn’t it? Um especially if you’re modelling the obesity one, because you could have some staff that could be slightly overweight that could take offence at that . . . it would have to be handled very carefully, wouldn’t it?’

Manager_ Mid_SES_Nursery_4

Developing a home component

In general, parents welcomed the idea of including a home learning component in the NAP SACC UK intervention:

If I was given something like that . . . um I’d have just welcomed the advice and I wouldn’t think you were trying to tell me what to do; you’re just trying to help me in the right direction. If there are a few things that I can improve upon, then brilliant.

Parent_High_SES_Nursery_2

However, many parents were concerned that this part of the intervention could be deemed to be invasive or ‘preachy’:

There’s a fine line with becoming too involved with how a parent is raising their child, so I would be cautious.

Parent_High_SES_Nursery_12

I think sometimes some people might think it’s a bit patronising. It’s quite obvious that children shouldn’t just sit around and watch TV [television], they need exercise.

Parent_Mid_SES_Nursery_3

Some parents cautioned that the home component may be received differently depending on social background:

I think there are some types of parents that will be hard to reach, so if you approach it in a non-judgemental way and you make it easily accessible for everyone no matter what background, I imagine there are some people who don’t have much money . . . they will feel different and I think it’s making those people feel welcome because it’s help for everyone.

Parent_Mid_SES_Nursery_11

Healthy/low-cost recipe and PA ideas were reported to be most attractive to parents as part of the home component:

Sometimes it’s cheaper or easier to buy junk food. So I think recipes is a good one, giving ideas.

Parent_Mid_SES_Nursery_11

I think a lot more should be available for children, I’ve been looking at gymnastics and dance classes for my daughter and they are just so expensive . . . you would love to send your children to all these classes, but you need ideas of things that don’t cost, or don’t cost a lot of money.

Parent_Midd_SES_Nursery_4

Many parents welcomed the idea of sharing healthy eating and PA ideas with others, and tip-sharing forums were suggested, either online (e.g. using social media) or at a physical meet-up:

You could probably maybe do workshops for parents, ways of getting vegetables into foods, things like that. It would give you a boost to do the right thing, wouldn’t it?

Parent_Low_SES_Nursery_6

It would be really handy to have a Facebook page with ideas of what you could cook for dinner tonight. A healthy meal that you could do, or something that you could do with the children.

Parent_Mid_SES_Nursery_4

Others suggested that the home component would be most successful if linked in with the nursery’s activities:

You could do something coming from the nurseries, like a welcome pack, or once a quarter maybe linked to the seasons, something like that. Different vegetables and things . . . In that you could have a couple of recipe ideas, or activities you can do at this time of year, or even go for a long walk and collect autumn leaves, pine cones to make Christmas decorations, all that sort of stuff. Seasonal fruit and veg and a couple of nice recipes to do with it. A little fun activity pack.

Parent_Mid_SES_Nursery_7

Parent–child cookery sessions and demonstrations at the nursery were also appealing:

I wonder whether if you had some kind of demo maybe, I don’t know whether the preschool would be involved with that. You could have a kind of demo, someone come along and cook something, and the children and the parents all stay together and have like a buffet or party, that maybe encourages the children to try something they haven’t and maybe the parents as well.

Parent_High_SES_Nursery_1

Finally, parents highlighted the importance of involving children in the home component as much as possible, as they were regarded by parents as ‘key’ to change in the home:

So anything that involves the parent going IN, I think they would be keen on and involving the children as well will mean once you’ve left this event, you take it home and if the children’s imagination has been captured and you’ve been there together, then I think that would be a very good way of getting the information home.

Parent_Mid_SES_Nursery_4

Development of NAP SACC UK and NAP SACC UK at Home

Summary

The phase 1 study found that nurseries reported a generally good standard of nutrition, but the extent to which nutrition guidance was used varied between settings, with some using no nutritional guidance at all. Most nurseries had space for the children to be physically active, which was usually outdoors. There was variation in the extent to which the outdoor space was used ‘all weather’ or on fine days only. Screen time was limited across settings, with few including television time in their daily routines. Children’s oral health was highlighted to be a growing concern in nurseries, and this concern was reinforced by an NHS oral health specialist, who was a member of our group of expert advisors to NAP SACC UK. Adaptations to NAP SACC were made in the light of the phase 1 study and NAP SACC UK at Home was created.

Sample size, eligibility, recruitment and randomisation

The sample size for this feasibility study was not informed by a power calculation. The sample size of 12 nurseries was chosen to provide information on variability within and between nurseries at baseline and follow-up, response rates and intracluster correlation coefficients (ICCs) in anticipation of a larger trial. A larger sample would not have been appropriate for a feasibility study and 12 participants was deemed a sufficient sample for the process evaluation, which was the most important part of this feasibility study.

The study took place in nurseries in two areas of England (North Somerset and Gloucestershire) and in the homes of children recruited to the study. North Somerset is a rural area adjacent to Bristol, with 14.1% of children living in poverty (per cent of children aged < 16 years in families receiving means-tested benefits and low income in 2012). 71 Gloucestershire is a large rural county to the north of Bristol. The health of people in Gloucestershire is generally better than the England average; however, 13.8% of children live in poverty. 72

The inclusion criteria for child-care providers were that they must be a day nursery, private nursery school, maintained nursery school, children’s centre with nursery, or preschool, in North Somerset or Gloucestershire. Excluded child-care settings were child minders, crèches, playgroups, primary school reception classes (where schools operate an early-admission policy to admit children aged 4 years) and au pairs. Settings were eligible if they had a minimum of 20 children aged 2–4 years who attend the child-care providers for at least 12 hours per week over 50 weeks of the year, or 15 hours per week in term time.

The NAP SACC UK study was discussed with North Somerset child-care provider managers at meetings convened by North Somerset Council and advertised in the Council’s early years newsletter. These opportunities were not available in Gloucestershire because of timing of recruitment. Child-care providers were sent a letter from the Council, project information sheet, reply envelope and form indicating if they wish to participate and reason for their response. Non-responders were followed up with a reminder and then a telephone call. All interested child-care providers were contacted by telephone to discuss the study following which, if the provider was still interested, they were offered a visit to discuss the intervention and study in more detail. A £200 incentive was provided to all participating nurseries at the end of the study.

Randomisation involved allocation to two arms: NAP SACC UK or usual practice. Twelve child-care providers (six in each area) were recruited to the trial, of which six were randomised to the control group and six to the intervention (three in each area). Allocation was conducted by an independent statistician at the Bristol Randomised Trials Collaboration, blind to the identity of the child-care providers. Stratified randomisation was used to ensure balance for (1) deprivation (using IMDs for the local super output area for 2010, where the provider is located), (2) size of child-care provider [small (≤ 48 children) or large (> 48 children)] depending on number of children attending, details obtained from the Council, Ofsted website or the nurseries own website] and (3) location (North Somerset and Gloucestershire). To achieve reasonably equally sized groups for randomisation, 12 groups were created across each of the two areas, with six lists created for each of low, medium and high IMD score. Each of the six lists by IMD category combinations was divided into two equal groups according to size.

Parents/carers were given a letter, project information sheet, reply envelope and form indicating if they wish to give consent for their child to take part in the study (sent at the end of August 2015). Research staff attended all nurseries late afternoon on between 1 and 3 days (depending on staff availability) to talk to parents about recruitment and answer any questions. All children received a small thank you gift [packet of stickers or a Mr Men™ (Mister Men Limited, London, UK) book] after each of the two data collections to encourage the prompt return of accelerometers.

The NAP SACC UK intervention

The NAP SACC UK intervention is based on the online Go NAP SACC intervention73 (but delivered in person) and was adapted for use in the UK during phase 1 of the feasibility study. It is based on social cognitive theory and the socioeconomic framework. In the feasibility study, the intervention was delivered by health visitors (NAP SACC UK partners) and local experts delivered the workshops for nursery staff. The intervention used in the NAP SACC UK feasibility trial is summarised using the Template for Intervention Description and Replication (TIDieR)74 12-item checklist in Table 5. The intervention also contained a home-based component, informed by other studies of behaviour change with parents/carers of young children use of digital media, and interviews and focus groups with parents/carers, nursery managers and health visitors. The intended behaviour change techniques used in the different elements of the NAP SACC UK intervention are outlined in Appendix 5, Table 32.

Outcome measures

Data collection

As this feasibility study was not designed to assess efficacy, effectiveness or cost-effectiveness, data collection was designed primarily to assess feasibility and acceptability. All measurements were completed at baseline and again at follow-up, except for the baseline nursery audits and demographic information provided on consent forms. Data collection methods comprised the following.

Data storage and management

The secure, web-based electronic data capture system REDCap was used to store study data. This tool was created specifically for clinical research. The study team built and modified electronic forms in the database with support from a university clinical data systems manager.

Data from questionnaires were stored in anonymised form using participant identification (ID) numbers. REDCap contains functionality that allowed the team to e-mail survey links directly to participants. It was used in this way to collect follow-up parent/carer questionnaire data, for those parents/carers who provided an e-mail address on their child’s consent form (the majority). NVivo data analysis software was used to store, code and undertake thematic analysis of anonymised transcripts of the process evaluation data. All data collected will be made freely and openly available for other researchers to use via the data.bris Research Data Repository (where consent was given for data to be shared); this will take place at an appropriate time with respect to a possible full trial.

Data analysis

The statistical analyses were primarily descriptive, providing estimates of eligibility, recruitment, intervention delivery and retention rates among this study population, with 95% confidence intervals (CIs) calculated to incorporate between-provider variation where appropriate. Summary statistics were calculated for the outcome measures using means and standard deviations (SDs) by allocation arm and key demographic variables to inform the sample size and recruitment plan for the main trial, if warranted. Differences were explored for what was identified to be the primary outcome for a future trial by study location (North Somerset/Gloucestershire) and deprivation (high vs. low). Comparisons were made between those who completed the study and those who dropped out to investigate if this is a potential source of bias. Missing data were not imputed for the purposes of the feasibility study. However, the extent of missing data was examined and described to inform the full trial. Stata^® v14 (StataCorp LP, College Station, TX, USA) statistical software was used for all analyses.

As this was a feasibility study, the sample size was not based on a power calculation, so the sample cannot provide a usefully precise estimate of the intervention effect. However, we were able to determine likely recruitment rate of nurseries and children, adherence to the intervention, and intracluster correlations in anticipation of a larger trial.

For qualitative data we aimed for a maximum variation sample of interviewees to achieve a broad perspective on the salient issues. Emergent issues from earlier interviews and focus groups were explored in subsequent interviews and the number of interviews undertaken was determined by data saturation (no new issues or themes emerging from within/across participants). All interviews and focus groups were audio-taped and transcribed verbatim. All the transcripts were read and reread in order to gain an overall understanding of participants’ views and experiences. Data were coded in NVivo software, and analysed thematically, allowing comparisons to be made within and across the interviews. Quotations which best represented the nature of each theme were extracted. In the process evaluation of the feasibility trial a total of 40 interviews were carried out and transcribed. One transcriber working within the University of Bristol was paid to transcribe 11 interviews; an outside transcriber with previous experience of working with the University transcribed 24 interviews, and the remaining five interviews were transcribed by one of the NAP SACC UK team members.

Health economics

Our aim was to pilot measures of resource use and estimate more precisely the cost of the intervention to inform a full-scale trial. We measured key cost components for the public sector, child-care providers and parents. We delineated resource use (e.g. hours), unit costs (e.g. cost per hour) and calculated mean provider and parental costs in the intervention and control groups. We estimated incremental costs and 95% CIs for descriptive purposes. We anticipated that the NAP SACC UK intervention would be unlikely to affect HRQoL in the short term, and any effect on HRQoL is more likely in the long term through changes in dietary habits, PA and BMI. However, we piloted a measure of HRQoL in order to explore any changes over the course of the trial and examine associations between PA and HRQoL.

The HRQoL was measured using the Paediatric Quality of Life Inventory (PedsQL) 4.0 for children aged 2–4 years91 at baseline and 8–10 months later. The instrument has been tested for reliability and validity in community settings91 including comparing HRQoL between preschool children with or without obesity. 92 The inventory has 21 items rating HRQoL in four domains: physical function, emotional function, social function and nursery function. Parents rated their child’s functioning related to each item on a scale of 0 to 4 (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem). The PedsQL items were reverse scored and linearly transformed onto a scale of 0–100, for ease of interpretation, so that higher PedsQL scores indicated better HRQoL. Missing observations were imputed, as per the PedsQL scoring instructions. 93

Family expenditure on PA of the 2- to 4-year-old child was collected from the parent questionnaire at baseline and 8–10 months later. Parents were asked to list all the physical activities their 2- to 4-year-old child had participated in over the past week and the associated cost, if any, of each activity (entry fees, membership, etc.). A subsequent question asked how many miles in the car were travelled to get to the activity. Expenditure on transport was calculated using the HM Revenue and Customs tax rates per business mile, costed at 45p per mile. 94 The cost of transport to the activities was added to the expenditure on physical activities to generate the total weekly expenditure on PA of the 2- to 4-year-old. Parents were also asked to estimate the time spent on their child being physically active including travel and waiting time. This time was converted into hours per week.

Data on food expenditure were collected through the parent questionnaire, where parents were asked to estimate how much they spent on food in either the last week or the last month. Data were converted to weekly expenditure. Food expenditure was separated into five domains: supermarket shop, convenience shop, takeaway food, café/restaurant food and other (e.g. school dinner money). Parents were also asked if the spending on food in that period had been typical.

Health-care use was collected through the parent questionnaire in which parents were asked to detail visits to health-care providers in the last month. These data were collected at baseline and at the 8- to 10-month follow-up. This included, general practitioner (GP)/family doctor, therapist (e.g. physiotherapist, dietitian) and hospital inpatient and outpatient visits. The costs of health-care use of the 2- to 4-year-old children were calculated by multiplying the mean number of visits by the associated Department for Health and Social Care NHS Reference Costs 2015–201695 and the Personal Social Services Research Unit Health and Social Care Unit Costs 2016. 96 At follow-up, a subsample of 35 parents were randomly selected (by the trials unit) to recall health-care use over the past 5 months (rather than the last month) to compare parent recall. These data were divided by five to give a monthly average.

Data were collected on parent time taken off work and the associated costs. Parents were asked how many days they had taken off work in the past month associated with the health of their 2- to 4-year-old child. Time taken off work was separated into three domains: paid time off work, unpaid time off work and annual leave days off work. The cost of paid time off was calculated by taking the average weekly salary from the Average Salary of Hours and Earnings Survey 2016. 97 The national median weekly salary of £539.00 was divided by five to provide a day rate of £107.80. This number was then multiplied by the number of paid days’ work parents took off because of their 2- to 4-year-old child’s health.

The costs to nurseries of preparing for and delivering the intervention were estimated using the reported time that nursery staff attended the workshop, recorded time with the health visitors and additional information from the nursery logs. The cost of the intervention to the nurseries was estimated using the average hourly rate for nursery workers and managers. 98 However, it was at the discretion of the nursery how they pay staff to attend the workshop. Not all nurseries paid their staff to attend the workshop.

All data relating to cost and HRQoL were combined with the parental mediator questionnaire and given to parents by nursery staff to return by post to the research team. At follow-up, all parents/carers who had provided an e-mail address on their child consent forms were e-mailed a link to complete the parent/carer questionnaire online, using the study’s database. Non-responders were sent a paper copy. Data were analysed using Stata MP 14.2 statistics and data analysis package. Mean differences at follow-up were tested using paired t-tests for food expenditure, PA expenditure, PedsQL score and child health-care costs. Costs and outcomes are presented in a cost–consequence table.

Process evaluation

Recruitment, retention and participant characteristics

Figure 4 summarises participation in the feasibility trial, with reasons for withdrawal from the study following the Consolidated Standards of Reporting Trials (CONSORT) guidance. Of the 14 nurseries approached in North Somerset, six (42.9%) gave consent to take part in the study. In Gloucestershire, of the 24 approached, six (25.0%) consented to participate, giving an overall consent rate of 31.6%. No large nurseries in the highest deprivation group were recruited in Gloucestershire. At least one nursery was recruited in each of the other five groups. Reasons for declining to take part included being too busy, staffing issues, financial issues and feeling that they did not need the intervention. No nurseries were lost to follow-up.

FIGURE 4.

The Consolidated Standards of Reporting Trials (CONSORT) flow diagram.

There were estimated to be 476 children potentially eligible to take part in the study. Of the 221 potentially eligible children in North Somerset, 97 (43.9%) parents provided consent for their child to take part in the measurements and 80 (31.4%) out of 255 potentially eligible children in Gloucestershire were given consent. The parental consent for all children was 37.2%. The 177 consented children were invited to take part in baseline data collection; one (0.6%) child’s consent was withdrawn by the parents prior to data collection commencing. A total of 175 out of the 176 remaining children provided some baseline data (99.4%) (one child was absent from nursery and parents did not complete baseline parental questionnaire). A further eight (4.5%) children were removed because they were ineligible, leaving 167 out of 168 children with data in the baseline analysis.

At the follow-up data collection, 147 (87.5%) out of 168 children at baseline participated in data collection. Two (1.2%) children had consent withdrawn, two (1.2%) refused to participate in measurements and their parents did not return follow-up questionnaires, eight (4.8%) moved nursery and nine (5.4%) moved to primary school and did not take up the offer to continue participation. Out of the 476 potentially eligible children at baseline, 147 (30.9%) children provided data at baseline and follow-up. This comprised 66 children in the intervention arm and 81 children in the control arm. Sending a link to the parental questionnaire by e-mail to a subgroup of parents at follow-up yielded a completion rate of 28% with 87% for those parents sent the questionnaire by post at follow-up. In the pilot of collecting weekend food and drink consumption CADET data from parents in two nurseries, 51.6% of parents returned the paper copy. For the parents in the two nurseries where data were collected over the telephone, the research staff had difficulty reaching the parents/carers even after four attempts at phoning.

The completeness of data by item for nurseries, children and parents is shown in Table 8 and the characteristics of nurseries, children and parents by study arm at baseline are shown in Table 9.

Outcomes

Health economics

Process evaluation

Summary

Progress against the progression criteria is summarised in Table 27. Recruitment of nurseries (31.6%) and children (35.3%) was lower than the progression criteria of 40%, but both were exceeded in one of the two study areas. No nurseries withdrew from the study. The intervention was delivered as planned in five out of the six intervention nurseries with high levels of feasibility and acceptability (there were particular circumstances in the sixth nursery), with the exception of the home component. It was feasible to recruit and train health visitors to deliver the intervention, but health visitors reported that they may not have capacity to deliver the intervention in the future alongside their usual workload.

The trial methods and design were acceptable and feasible. The number of children lost to follow-up was 24 (14.2%), and this was due to withdrawing consent (1.8%), child refusal to participate on the day (1.2%), children moving to primary school (6.5%) or children moving nursery (4.7%). The response rate was 145 (85.8%) at follow-up. Although the study was not powered to measure effectiveness, accelerometer measured total PA and MVPA were higher in the intervention arm than in the control arm after the intervention. The ICC for total activity was estimated at 0.02 (95% CI < 0.0001 to 0.95). Assuming a coefficient of variation in participating children per nursery of 0.4, 30% incomplete data and an ICC of 0.05, 720 children at 52 nurseries will give 90% power at the 5% significance level to detect a 17-minute increase. The average cost of delivering the intervention was estimated at £1184 per nursery, and nurseries incurred, on average, an additional £717 for staff to attend the two workshops.

Mediator questionnaire test–retest reliability study overview

The aims of the current study were to test the NAP SACC UK parent and nursery staff questionnaire mediators for (1) acceptability by examining response rates and missing data, (2) maximising the internal consistency of the scales using Cronbach’s α coefficients and (3) reliability by conducting test–retest analyses using weighted kappa coefficients and paired t-tests.

Development of the mediator questions

The mediator questions for parents and nursery staff (see Appendices 2 and 3) were based on the questionnaire items used in the Active for Life Year 5101 study and were adapted using the NAP SACC UK self-assessment form. The self-efficacy, motivation and knowledge questions were split into two sections: children’s nutrition/oral health and children’s PA. All the self-efficacy questions started with the same stem, ‘I feel able to’, and were followed by dietary, PA or oral health-related behaviours where the response options were: 1 – ‘Disagree a lot’, 2 – ‘Disagree a little’, 3 – ‘Not sure’, 4 – ‘Agree a little’ and 5 – ‘Agree a lot’. The same health-related behaviours were included in the motivation questions but used the stem, ‘I am motivated to’. The motivation response options were: 1 – ‘Never’, 2 – ‘Sometimes’, 3 – ‘I don’t know’, 4 – ‘Most of the time’ and 5 – ‘Always’. Multiple-choice questions were set for the knowledge items and varied in terms of having one or multiple correct response options.

Sample and recruitment

Nurseries from Bristol, UK, were recruited through postal invitations followed by an e-mail invitation 10 days later. Participating nursery managers recruited nursery staff and parents via e-mail. Parents were also recruited via an online advert on the survey forum of the UK-based parenting website (www.netmums.com). Inclusion criteria were nursery staff and parents or guardians who worked with or had 2- to 4-year-old children. Written informed consent was obtained from the nursery managers and online consent was gained from each participant prior to data collection commencing.

Data collection

Nursery managers were instructed to send a link to the online nursery staff questionnaire via e-mail to all nursery staff who worked with 2- to 4-year-olds. This was repeated for the parent questionnaire to parents who had 2- to 4-year-old children. Participants were asked to provide their e-mail address at the end of the questionnaire and those who did were automatically sent the questionnaire again 1 week later. They were sent a reminder e-mail a further 3 days later. Participants’ questionnaires were included if the second administration of the questionnaire was completed between 7 and 11 days after the first administration. Each participant was reimbursed with a £10 voucher on completion of the first and second administrations of the questionnaire.

Data analysis

Descriptive statistics were used to summarise the participant characteristics, response rates and missing data. Using the data from the first administration of the questionnaire, Cronbach’s α coefficients were calculated to determine the internal consistency of the four scales: nutrition self-efficacy, PA self-efficacy, nutrition motivation and PA motivation. Values of at least 0.7 were considered acceptable. 102 To assess test–retest reliability of the items, weighted kappa coefficients for ordinal variables103 were calculated. To interpret the kappa coefficient results, the cut-off points detailed by Landis and Koch104 were used: 0.00–0.20 = ‘slight’; 0.21–0.40 = ‘fair’; 0.41–0.60 = ‘moderate’; 0.61–0.80 = ‘substantial’; and 0.81–1.00 = ‘almost perfect’ agreement. For the knowledge questions, the percentage of correct answers was derived for each participant and paired t-tests were carried out on these continuous test and retest summed scores.

Participants

Demographic characteristics for the 82 parents and 69 nursery staff are shown in Appendix 9, Table 43. Most parents were in the 31–35 years age group (43.9%) whereas nursery staff were mainly in the 25–30 years age category (31.9%). The highest level of education was a university degree for both parents (41.5%) and nursery staff (37.7%).

Acceptability and missing data

The number of times that individuals gave consent on the questionnaire link was 130 and 103 for parents and nursery staff respectively; it was not possible to distinguish whether or not the same individuals clicked consent multiple times, as they did not have to provide any identifying information (e.g. e-mail addresses). A total of 102 parents completed the first administration of the questionnaire and 88 parents (86.3%) completed it for the second administration. For the nursery staff questionnaire, 86 and 74 (86.0%) participants completed the first and second administrations, respectively. A total of 73 (89.0%) and 70 (85.4%) parents completed all the self-efficacy and motivation questions in the first and second questionnaire, respectively. The number of nursery staff participants completing all the questions was 58 (84.1%) for the first and 61 (88.4%) for the second administration.

Cronbach’s α coefficients

The Cronbach α coefficients of the items within the four scales from the parent questionnaire are presented in Appendix 9, Tables 44 and 45. The final column represents the α coefficients for the test scale if the item is removed. The overall Cronbach’s α for the scale is also presented in the final column. The nutrition self-efficacy scale shows an acceptable level of internal consistency (α = 0.80). The PA self-efficacy scale has the weakest internal consistency in the parent questionnaire but is still at an acceptable level (α = 0.73). The removal of the item 17 relating to the provision of opportunities to walk to/from nursery would noticeably improve the internal consistency of the scale (α = 0.81). The nutrition motivation scale shows a high level of internal consistency (α = 0.86). The PA motivation scale demonstrates the highest overall Cronbach’s α (α = 0.89). Unlike the equivalent item in the PA self-efficacy scale, the removal of the item 37 has less of an effect on the internal consistency (α = 0.92).

Appendix 9, Table 45, shows the Cronbach α coefficients for the nursery staff questionnaire. The nutrition self-efficacy and the nutrition motivation scales both had α coefficients of 0.89, which shows a high level of internal consistency. Both the PA self-efficacy and the PA motivation scales also demonstrated high levels of internal consistency as the Cronbach’s α coefficients were 0.91.

Test–retest analyses

Test–retest analyses found that most of the weighted kappa coefficients for individual items fell under the ‘moderate’ category for the parent (75.0%) questionnaire and for the nursery staff (55.8%) questionnaire (see Appendix 9, Table 46). Paired t-tests found that knowledge scores for parents were higher in the questionnaire’s second administration [t = –3.23, degrees of freedom (df) = 81; p = 0.002] but there was no strong evidence for a substantial increase in the nursery staff’s score in the second administration (t = –0.67, df = 68; p = 0.503).

Summary

Participating nursery managers recruited nursery staff and parents via e-mail, and the respective questionnaires were sent out as a weblink and completed twice, 1 week apart. A small number of parents were recruited online (via www.netmums.com; London, UK). The acceptability of the questionnaires was explored by looking at response rates and missing data. Cronbach’s α coefficients were used to look at the internal consistency of the four scales (i.e. nutrition self-efficacy, PA self-efficacy, nutrition motivation and PA motivation). Test–retest analyses (weighted kappa coefficients and paired t-tests) were used to determine whether or not the items/scales are reliable. We have produced a novel tool that can be used to measure parental and nursery staff’s self-efficacy, motivation and knowledge towards diet, oral health and PA. Overall, these analyses have demonstrated that the scales show good internal consistency and test–retest reliability.

Overview

An additional feasibility study was undertaken after the end of the feasibility trial with the aim to ascertain the feasibility and acceptability of taking photographs of the foods and drinks served to 2- to 4-year-olds in nurseries to estimate portion size served and caloric intake of individual children (to replace CADET in a full trial as a method of collecting nutrition data in nurseries). This study also aimed to determine the number of children from whom one researcher could feasibly collect complete food and drink data to inform a future trial.

Sample and recruitment

A purposeful sample of nurseries within Bristol, to allow for variation in deprivation and meal provision (nursery-provided food and family-provided food), were invited to take part, with the aim of recruiting four nurseries. Nurseries were approached by e-mail and provided with an invitation letter, nursery information sheet, consent form and camera policy. Nursery managers were given 2 weeks to respond with a reminder e-mail sent after 1 week. The camera policy included details regarding storage of the camera during non-eating times and a requirement that the nursery manager check the photographs at the end of the data collection day to ensure that there were no concerns about inappropriate use of the camera. It was requested that the policy was signed along with the consent form.

Once a nursery manager had consented to taking part in the study, a date for data collection was arranged and nursery managers were asked to briefly explain mealtimes, locations and serving arrangements. Following this, information packs for all parents/carers of 2- to 4-year-olds that were going to be present on the day of data collection were posted to the nursery managers. The packs included a letter, an information sheet, an opt-out consent form and a stamped addressed envelope. Nursery managers were asked to hand these to parents/carers. Parents/carers were given 2 weeks to provide opt-out consent if they did not want their child to take part in the study.

Data collection

Two researchers visited each nursery for 1 full day of data collection. Photographs were taken of as many consented children’s food and drink as possible. Researchers followed the Fieldworkers’ Standard Operating Procedures that were developed for this study.

A set of laminated cards were prepared to be placed next to the children’s plates for each photograph. A standard credit-card-sized marker was printed on the laminated card to aid perspective adjustment and later portion size estimation. Dry-wipe marker pens were used to indicate on the laminated card the type of meal, whether the photograph was taken before or after eating and whether the photograph was of the first or second helping. The researcher ID and participant ID were written on the front of the laminated card, with the child’s name written on the back so that all meals throughout the day could be matched to that child. The laminated cards were left at the nurseries after data collection.

The type and number of drinks were recorded in one-quarter cup increments on a fieldworker data collection sheet to save time having to take ‘before’ and ‘after’ photographs of each refill of drink. A full cup of water was also weighed to determine the volume of water being drunk based on the one-quarter cup increments recorded on the data collection sheet. A researcher took one photograph before the meal and one after, at a 45-degree angle and approximately at arm’s-length distance to include all the food on the plate. The aim was for no part of the child to be in the photograph, however, it was anticipated that occasionally part of a child’s hand, arm or body would be shown in the photograph. If a child received additional portions, a photograph was taken of the ‘empty’ plate before and after an additional serving to capture a photograph of the new portion and then a final photo when the child had finished eating to capture any leftovers or confirm that the entire serving was consumed.

To optimise portion size estimation for each food in a mixed meal, foods should be separated on the plate and not layered on top of one another (e.g. pasta on one side and sauce on the other side of the plate, or sandwiches opened up to reveal the contents). To overcome the time demands of separating foods on each individual child’s plate, a portion was provided to the researchers with foods separated. For composite meals (e.g. cottage pie, curry) the researchers asked the nursery staff for a detailed description of the ingredients and quantities and for a portion. When a meal could not be weighed, standard recipes were used based on the National Diet and Nutrition Survey nutrient data bank.

In nurseries that allowed packed lunches, each consenting child’s packed lunch was photographed and each element weighed and recorded. A new pair of latex gloves was used for each packed lunch to avoid cross-contamination of allergens.

At the end of the data collection day, nursery staff who were present on the day were asked to complete a short questionnaire about their views and acceptability of the data collection method. The nursery manager was asked to check all the photograph thumbnails to confirm they had no concern about the content of the photographs.

Data analysis

The photographs were annotated as relevant and submitted for analysis to Pennington Biomedical Research Center (PBRC), an organisation based in the USA that specialises in estimating food portion and nutrient data using food photography. 105–107 No information that could identify a child or nursery was sent to PBRC. Processing of photographs involved trained members of the PBRC team using the photographs and annotations to match foods pictured to food in a UK food composition database. Once a matching food was chosen, the portion size of the food was estimated by comparing the photograph to standard photographs of that food where portion size (grams) was known. The standard marker included within photographs was used to rescale photographs to the same size as the standard photographs, which aided accurate estimation of portion sizes. Portion size and food composition information was then combined to generate nutrient contents of the meal eaten. Questionnaire data from nursery staff were entered into a Microsoft Excel^® (Microsoft Corporation, Redmond, WA, USA) spreadsheet and summarised using descriptive statistics. Fieldworkers were asked to complete detailed observation notes and these were analysed thematically.

Recruitment

Of the seven nurseries invited, four (57%) gave consent to take part in the nursery food photography feasibility substudy. Reasons for non-participation by nurseries were staff shortages, tight workloads and changes, for example, in management structures. One nursery mentioned not wishing to take part because of a small dining area that would have been a struggle to accommodate any extra adults or equipment. The nurseries were all located in Bristol and differed in their size, IMD and types of meals provided. One nursery permitted packed lunches. One nursery had a chef and three nurseries received their meals from external catering companies. In addition to lunch and snacks, two nurseries provided breakfast and two provided an afternoon meal.

Nursery managers estimated a total of 153 eligible children to be present on the days of data collection. A total of 180 letters were given to parents by nursery staff giving information about the study and the opportunity to opt their child out of the study; seven opt-out consent forms (4%) were received.

On each day of data collection, the two fieldworkers collected data from one group of children throughout the day. In two nurseries, researchers followed children aged 3–4 years, and in two other nurseries researchers followed children aged 2 years. Across the nurseries, data from a total of 51 children were collected on at least one eating occasion. Of these 51 children, 26 (51%) had data for all eating occasions at nursery on the day of data collection.

Staff present at mealtimes and throughout the day of data collection were asked to complete the staff questionnaire (see Appendix 10) at the end of the day. All 19 staff who were approached completed and returned the questionnaire.

A total of 307 photographs were taken across the days of data collection. When staff looked through photographs at the end of the day, one photograph was deleted as the photograph included the participant’s name on the nursery place mat. Figure 5 gives an example of before-and-after photographs.

FIGURE 5.

(a) Before and (b) after photographs of a meal in a nursery.

Feasibility of data collection

It is feasible to use a tablet in nurseries for photographic data collection. In combination with a written observation sheet to capture anything not photographed, a good estimate of what children aged 2–4 years at nurseries eat and drink throughout the day can be made. The wide screen of the tablet made it easy to capture all food items and the laminated ID card in one photograph. It was often not feasible to take photographs at a 45-degree angle and an arm’s length away, given the small space provided for each plate at the table, but this did not have an impact on the estimation of portion size.

Lessons learnt

Summary

It is feasible to collect diet data in a nursery setting by taking photographs. A combination of photographic and observational data collection using two fieldworkers together means that up to 10 children can be followed in 1 day, providing that the children are seated at the same table for all meals and that children are served sequentially.

Recruitment

Recruitment of a local authority to participate in a trial should include a thorough check of other early years/preschool health initiatives (including non-health initiatives), which could make recruitment difficult or affect the control groups. This learning particularly draws on the phase 1 findings and decision to change the second local authority from Wales to Gloucestershire, but also the experience within Gloucestershire of other initiatives. The impact of this for recruitment to a full trial could be that it will be more difficult to recruit cities in particular, because many have developed healthy preschool programmes or have other city-wide early years initiatives. It may also mean that recruitment of early years settings may be more difficult in local authorities that are part of the ‘Bristol Standard’ family, where many early years settings are undertaking the Bristol Standard quality improvement programme. These considerations will be taken into account in choice of local authorities for a future full trial.

It was helpful attending the local authority’s regular meeting with child-care providers to inform nursery managers of the trial and, if the study progressed to a full-scale trial, this level of local engagement would be important. Nursery recruitment may be aided by creating a short online film, with interviews from managers, NAP SACC UK partners and parents from the feasibility study highlighting what it involved, as well as the nursery staff and NAP SACC UK partners’ enthusiasm for the intervention and the acceptability of the feasibility study. This approach has been used by GoActive108 (www.cedar.iph.cam.ac.uk/research/directory/goactivestudy/). The film should feature nurseries from deprived areas to highlight potential benefits of reducing health inequalities to attract large nurseries in deprived areas. A future trial should ensure that the memorandum of understanding is signed by the manager (not deputy, to avoid the problem encountered at one nursery, which did not fully take part in the intervention) after a briefing meeting with staff and the manager.

To increase child recruitment rates, the acceptability of using parental opt-out consent for some or all data should be discussed with the ethics committee (of note, opt-out consent was used in the nursery food photography substudy and is used routinely by NCMP for national data collection). Recruitment of children could be increased by involving nursery staff in communicating with parents about the study. This would require a member of the research team to discuss the study and child eligibility with staff (not only the manager) and show staff the recruitment packs. This process could also reduce the number of ineligible children included in the denominator. Attendance by research staff when parents are collecting their children on at least three afternoons per nursery may increase recruitment, allowing parents to consider the study and ask questions. Nursery staff should be provided with a list of children for whom no response has been received so that they can remind parents to return the consent form.

Professor Dianne Ward, the founder of NAP SACC in the USA, has identified lessons for conducting environmental interventions in early years settings. These include:

• Ensure that the intervention is based on a behaviour change theory.

• An advisory group should inform the intervention and delivery.

• Realistic recruitment targets should consider the economic nature of child care.

• Data collection needs to be flexible with realistic sample size calculations because of high rates of child (and sometimes provider) turnover.

• Interventions that are relatively easy to implement are more likely to appeal to a wide variety of providers. 109

Of particular note for the NAP SACC UK study is the reality that recruitment, particularly dual recruitment of nurseries and children/parents, is challenging and requires resources and time. Such realism is required with consideration for the sample size and resource requirement for a future trial, particularly if meaningful dietary measures are to be included.

Data collection

Although the acceptability of children wearing accelerometers was good, the number of children meeting the wear-time criteria of ≥ 480 minutes per day was not large. A number of studies that used accelerometers with preschool children have a used less strict wear-time criteria for valid days of accelerometer data. For example, Pate et al. ’s study in US preschools included children in the analysis if they provided accelerometer data for ≥ 50% of the school day for 3 days, with a full day being > 6 hours (e.g. 180 minutes per day minimum wear time). 48 Stanley et al. 52 considered > 3 hours per day on ≥ 1 day as valid wear time for a study in a preschool setting.

Given the turnover of children between early years settings and progression to primary school, consideration should be given to a repeat cross-sectional study design within the RCT to maximise assessment of environmental changes on the children within the nursery at each time point.

The use of laptop computers for CADET data collection was not trialled as it would have been cumbersome to use a laptop in the nursery environment. The use of tablets should be explored further for data collection if adequate battery power and speed of data entry is possible with different devices or models; however, paper data collection was acceptable and practical.

In a full-scale trial, parents should not be asked to report costs of food and PA, health-care use or time off work, because there were too many missing data, these data were highly variable and these costs were unlikely to be affected to a great extent by the intervention.

The methods used in the food photography substudy should be adopted for a phase 3 trial to give more detailed information about portion size and food/drink consumption. Among the parents who responded, a high percentage gave consent for data linkage to NCMP height and weight data collected in schools. Therefore, requesting opt-out consent for data linkage to NCMP should be included in a full trial.

The EPAO data were collected on 1 day for each nursery at baseline and follow-up. With the variability of activities, weather and food provided between days we were concerned that one day of observation was not reliable. The EPAO provides useful contextual information about the nurseries, but it is questionable whether or not it is a reliable enough measure to be included as an outcome measure in a full trial. The original development of the instrument concluded the tool is a ‘stable and reasonably accurate instrument . . . However, a more robust, less subjective measure would be more appropriate for researchers seeking an outcome measure to assess intervention impact.’110

A phase 3 trial should measure how the intervention is sustained over time with respect to staff turnover and whether changes are embedded as ‘the way things are done’ or diluted. Furthermore, an objective measure of oral health should be included as a secondary outcome.

Intervention delivery

To ensure timely completion of the Review and Reflect form and maximise the number of nursery staff attending the two workshops (to coincide with inset days, or avoid planned annual leave and nursery closures), the NAP SACC UK partner and nursery manager meetings and two workshops should be booked with all nurseries at an early stage and prior to randomisation (cancelling the dates in control nurseries after randomisation). This would have the additional advantage of nursery managers being fully aware of the time commitment required for the intervention prior to randomisation as a further check, in addition to the signed memorandum of understanding.

The timing of the elements of the intervention should be:

• NAP SACC UK partner and nursery manager meet to jointly complete the Review and Reflect tool.

• Workshop includes the manager highlighting areas for potential improvement identified in the Review and Reflect tool.

• Staff suggest goals at end of workshop and confirm action plan with NAP SACC UK partner in subsequent meeting.

The intervention should be extended to 1 year to include two cycles of the Review and Reflect and goal-setting process, with a supplementary workshop after 6 months. Process data suggest partners and managers focused initially on easy-to-achieve goals. Allowing for a second cycle of goal-setting would encourage them to extend their goals beyond the ‘easy wins.’ As the workshops appeared important in motivating staff, an additional workshop at this point is recommended to encourage commitment from staff. The intervention could be improved by providing template copies of relevant policies (e.g. nutrition, PA, screen time, oral health, dental registration questions for registration pack).

Communication with nurseries at the beginning and throughout the intervention should make clear when the support from the NAP SACC UK partner will end. In addition, for the control nurseries, there should be ongoing communication so there is not a long period between annual data collection periods. Consideration of provision of an alternative health intervention could be considered for control groups (e.g. sun protection or hand hygiene).

During baseline data collection, it was observed that a small number of children in approximately half of the nurseries were bringing in packed lunches from home. An information sheet111 is available from the Children’s Food Trust on healthy packed lunches for early years and the national Change4Life website112 has a page with ideas for packed lunches. This information could be included in the information provided to the NAP SACC UK partners in a phase 3 trial, as an additional resource. Staff from Public Health England and the Children’s Food Trust anticipated government policy to increase free early years education from 15 to 30 hours for 3- to 4-year-olds (for parents working a minimum number of hours) and in September 2017 may increase lunchbox provision (Alison Burton, Public Health England, 2017, personal communication, and Patricia Mucavele, Children’s Food Trust, 2017, personal communication). 23 The five nursery managers attending the lay advisory group thought that increases in lunchboxes would be minimal but would increase in some settings. Therefore, the Review and Reflect tool should also incorporate best practice standards for lunchbox provision. The design of this could further be supported by work on lunchbox quality in the UK,113 Australia43 and USA. 114

The pressure of health visitors’ capacity to deliver the intervention necessitates flexibility to consider different models of delivery. If NAP SACC UK is delivered by a less experienced group of staff in a future trial, additional training will be necessary to ensure that these individuals are adequately supported. This should be provided at an earlier stage of the intervention, with additional top-up training to allow staff to discuss emerging issues.

Summary

The feasibility study has identified a number of modifications to improve recruitment, data collection and intervention delivery. These are summarised in Table 28.

Summary of findings

The phase 1 study found that nurseries reported a generally good standard of nutrition, but the extent to which nutrition guidance was used varied between settings, with some using no guidance. Most nurseries had space for children to be physically active, which was usually outdoors. There was variation in the extent to which the outdoor space was used regardless of weather, or only on dry days. Screen time was limited across settings, with few including television time in their daily routines. Children’s oral health was highlighted as a growing concern in nurseries, and this concern was reinforced by an NHS oral health specialist who was a member of our group of expert advisors to NAP SACC UK. Adaptations to NAP SACC were made in the light of the phase 1 study and NAP SACC UK at Home was created.

In the phase 2 feasibility RCT, recruitment of nurseries (31.6%) and children (35.3%) was lower than the progression criteria of 40%, but both were exceeded in one of the two study areas. No nurseries withdrew from the study. The intervention was delivered as planned in five out of the six intervention nurseries with high levels of feasibility and acceptability (there were particular circumstances in the sixth nursery), with the exception of the home component. It was feasible to recruit and train health visitors to deliver the intervention, but health visitors reported they may not have capacity to deliver the intervention alongside their usual workload.

The trial methods and design were acceptable and feasible. The number of children lost to follow-up was 24 (14.2%), because of withdrawing consent (1.8%), child refusal to participate on the day (1.2%), children moving to primary school (6.5%) or children moving nursery (4.7%). Eighty-five per cent (n = 145) of children were followed up for data collection, but not all children provided all data at baseline and follow-up. Although the study was not powered to measure effectiveness, accelerometer-measured total PA and MVPA were higher in the intervention arm than in the control arm after the intervention. The ICC for total activity was 0.02 (95% CI < 0.0001 to 0.95). The average cost of delivering the intervention was estimated at £1184 per nursery; nurseries incurred on average an additional £717 for staff attendance at two workshops.

The two substudies found the mediator questionnaire to be reliable and the methods of collecting diet data using photography to estimate portion size to be feasible.

Progression criteria

Chapter 5, Table 27, outlines the trial outcomes for each of the progression criteria. These criteria were met in full except for the recruitment of nurseries and children and the feasibility of the NAP SACC UK at Home component. Although the overall recruitment rates for nurseries and children were below the target 40%, both were exceeded in North Somerset, where the length of recruitment was longer, and the independent TSC agreed that these data showed recruitment is feasible.

Implications for future research

Strengths and limitations

This is a study in the UK that has tested the feasibility of a combined nutrition and PA environmental intervention in nurseries, with the additional component of oral health. The adaptation of the intervention from the USA was well informed by communication with parents, nursery managers and providers of services in early years settings.

For a feasibility study, it was a strength that two local authorities were involved, which included a range of city, small town and rural areas and neither area was adjacent to the university (where settings are more likely to be exposed to opportunities to take part in research), therefore giving a good indication of recruitment in other areas of the country. The intervention and trial methods were tested in a good number of nurseries and with a large number of children. Rates of nursery and child recruitment were reasonable. The retention of nurseries was excellent and retention of children was good where the children stayed within the nurseries; we deliberately tested the feasibility of following children beyond their time in nursery with the progression to school.

Objective measures of PA, diet, zBMI and the nursery environment were collected from participants at two time points. The study incorporated a detailed process evaluation that has allowed us to address the progression criteria from the perspectives of parents, nursery staff and NAP SACC UK partners. The study further benefited from a detailed test of measures of HRQoL and cost to inform a future assessment of cost-effectiveness.

The intervention was provided free to nurseries. Although the nurseries incurred the cost of staff time to take part, none of the six intervention nurseries raised this as a concern and only one nursery decided not to take part prior to recruitment because of this particular concern. All children in nurseries were potentially able to benefit from improvements made by the nurseries.

We have reported the intervention in accordance with the TIDieR framework and CONSORT reporting guidelines (with the CONSORT flow diagram; see Figure 4).

The data collection using CADET allowed us to assess food consumption by food group but not by portion size, because some nurseries reported making changes in portion size and this was not measured objectively. The number of children with complete accelerometer data at baseline and follow-up for the required wear time was low. Response rates from parents to complete the parent questionnaire were lower at follow-up. Both could be addressed through use of incentives and different protocols for data collection in a full trial;48 we would not intend to measure parental costs of diet and PA, health-care use or time off work (because there were too many missing data, these data were highly variable and these costs were unlikely to be affected much by the intervention).

We were not aware that there were two other quality improvement programmes available to nurseries in Gloucestershire prior to recruitment and, therefore, these were not part of the exclusion criteria for recruiting nurseries. Many nurseries in Gloucestershire were taking part in the ‘Bristol Standard’ and the pilot ‘Smiles Better award’. The Bristol Standard addresses 10 dimensions of educational quality (including health dimensions) across the nursery environment through a process of self-reflection, evaluation and goal-setting by nursery staff. Two out of the six recruited nurseries in Gloucestershire were also involved with the Bristol Standard. The Smiles Better award addresses oral health. The recruitment rate may have been higher had we excluded nurseries participating in other non-health quality improvement programmes in Gloucestershire. This was discussed after recruitment with the TSC; the TSC advised it would have been reasonable for nursery participation in quality improvement programmes, other than NAP SACC UK, to have been included in the exclusion criteria. If this had been an exclusion criterion the nursery recruitment rate would probably have been higher. The eligibility criteria for a future trial will need to consider whether or not nurseries should be excluded if they are already committed to other quality improvement programmes because of the capacity of nurseries to take part in multiple programmes.

We did not recruit any large nurseries in the highest deprivation group. Nurseries did not need to give a reason for not taking part and, therefore, we have limited information as to why these nurseries chose not take part. It is possible that the large nurseries in more deprived areas have more children who do not have English as a first language and have more children aged 2 years accessing the free child care that is means-tested for 2-year-olds. Therefore, these nurseries may have a greater workload and taking part in a research study may be regarded to be an additional burden. For a full trial, as part of the recruitment, we will include large and deprived nurseries in a recruitment video and ensure that issues regarding the benefits of reducing health inequalities are highlighted, to help large nurseries in deprived areas to identify with other nurseries that took part and to make the study feel manageable, attractive and of importance to their children.

In this study, zBMI was used as the measure of adiposity for children. We recognise that this cannot provide data on fat mass and fat-free mass, which may be important and could be detected by other approaches, such as dual-energy X-ray absorptiometry (DEXA) scans. 115 However, these methods are not applicable for use within a large field study and it would not be feasible to use such an approach in a definitive trial without substantial increases in participant burden and research cost. Thus, despite the potential limitations zBMI is the most appropriate measure for this study.

Conclusions and recommendations

The NAP SACC UK intervention (without the home component) and trial design have been found to be acceptable to nursery staff, parents and NAP SACC UK partners. The delivery of a cluster RCT, with process and economic evaluations, was feasible. The data indicate that NAP SACC UK has promise to increase PA levels of children aged 2–4 years during their time at nursery. Collectively, the findings from this study support the progression to a phase 3 trial of NAP SACC UK. A multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of NAP SACC UK has been funded by NIHR (and will start in July 2019).

Contributions of authors

Dr Ruth Kipping (Senior Research Fellow, Public Health) was the principal investigator, obtained the funds for the study and wrote the first draft of the monograph.

Dr Rebecca Langford (Research Associate, Public Health) undertook the process evaluation, collected and analysed the data wrote the results for publication and wrote the process evaluation methods and results sections of the monograph.

Dr Rowan Brockman (Research Associate, Public Health) collected and analysed data from the phase 1, wrote the phase 1 methods and results sections of the monograph and contributed to adapting the NAP SACC intervention and writing the mediator questionnaires.

Ms Sian Wells (Trial Manager, Public Health) managed the study and the ethics applications, collected phase 1 data, was involved with adapting the NAP SACC intervention, adapting the self-assessment tool and the EPAO and contributed to writing the monograph.

Professor Chris Metcalfe (Professor, Medical Statistics) was co-applicant, co-designed the study, oversaw the data analysis and interpretation and contributed to writing the monograph.

Dr Angeliki Papadaki (Senior Lecturer, Nutrition) was co-applicant, co-designed the study, advised on the diet data analysis and interpretation and contributed to writing the monograph.

Dr James White (Senior Lecturer, Public Health) was co-applicant, co-designed the study, advised on the data analysis and interpretation and contributed to writing the monograph.

Professor William Hollingworth (Professor, Health Economics) was co-applicant, co-designed the study, oversaw the data analysis and interpretation of the economic and health-related quality-of-life interpretation and contributed to writing the monograph.

Professor Laurence Moore (Professor, Public Health) was co-applicant, co-designed the study, advised on the management of the study, data analysis and interpretation and contributed to writing the monograph.

Professor Dianne Ward (Professor, Nutrition and Physical Activity) was co-applicant, co-designed the study, advised on the management of the study, data analysis and interpretation and contributed to writing the monograph.

Professor Rona Campbell (Professor, Public Health) was co-applicant, co-designed the study, advised on the management of the study, data analysis and interpretation and contributed to writing the monograph.

Mr Bryar Kadir (Research Associate, Medical Statistics) conducted the analysis of the data.

Ms Laura Tinner (PhD student, Public Health) conducted the analysis of the health economic and health-related quality-of-life data, EPAO as well as the cost of intervention delivery data. She undertook the design, data collection and analysis of the nursery food photography feasibility substudy.

Dr Vanessa Er (Research Associate, Public Health) conducted the analysis and interpretation of the diet data, and contributed to writing the diet section of the monograph.

Ms Kaiseree Dias (PhD student, Public Health) conducted the design, data collection and analysis of the mediators’ questionnaire test retest substudy.

Ms Heide Busse (PhD student, Public Health) undertook the design, data collection and analysis of the nursery food photography feasibility substudy.

Ms Jane Collingwood (Trial Co-ordinator, Public Health) co-ordinated the study, undertook data collection and contributed to writing the monograph.

Dr Alexandra Nicholson (Trial Co-ordinator, Public Health) managed the study and contributed to writing the monograph.

Dr Laura Johnson (Senior Lecturer, Nutrition) co-designed the nursery food photography feasibility substudy and contributed to the data analysis, interpretation and contributed to writing the monograph.

Professor Russell Jago (Professor, Physical Activity) was co-applicant, co-designed the study, advised on the management of the study, data analysis and interpretation and contributed to writing the monograph.

All authors reviewed various sections of the monograph and made critical revisions to relevant sections. All approved the final submission.

Publications

Brockman R, Jago R, White J, Campbell R, Hollingworth W, Metcalfe C, et al. NAP SACC UK: Adapting a US Environmental Intervention in UK Nurseries to Increase Physical Activity and Healthy Eating in 2–4 Year Olds. Oral Presentation. Bristol: South West Public Health Scientific Conference 2016; 2016.

Langford R, Jago R, White J, Moore L, Papadaki A, Hollingworth W, et al. A physical activity, nutrition and oral health intervention in nursery settings: process evaluation of the NAP SACC UK feasibility cluster RCT. BMC Public Health 2019;19:865.

Brockman R, Jago R, White J, Campbell R, Hollingworth W, Metcalfe C, et al. NAP SACC UK: Adapting a US Environmental Intervention in UK Nurseries to Increase Physical Activity and Healthy Eating in 2–4 Year Olds. Oral Presentation. Norwich: UKCRC 2016 Conference; 2016.

Brockman R, Jago R, White J, Campbell R, Hollingworth W, Metcalfe C, et al. Parents’ and staff’s views of adapting the Nutrition and Physical Activity Self-Assessment for Childcare in UK nurseries to improve physical activity and healthy eating. Lancet 2016;388:S22.

Kipping R, Jago R, Metcalfe C, White J, Papadaki A, Campbell R, et al. NAP SACC UK: protocol for a feasibility cluster randomised controlled trial in nurseries and at home to increase physical activity and healthy eating in children aged 2–4 years. BMJ Open 2016;6:e010622.

Kipping R, Langford R, White J, Metcalfe C, Papadaki A, Hollingworth W, et al. NAP SACC UK: Feasibility Cluster Randomised Controlled Trial and Process Evaluation of an Environmental Intervention in Nurseries and a Web-Based Home Intervention to Increase Physical Activity, Oral Health and Healthy Eating in Children Aged 2–4 years. Oral Presentation. Bristol: South West Public Health Scientific Conference 2017; 2017.

Kipping R, Langford R, White J, Metcalfe C, Papadaki A, Hollingworth W, et al. NAP SACC UK: Feasibility Cluster Randomised Controlled Trial and Process Evaluation of an Environmental Intervention in Nurseries and a Web-Based Home Intervention to Increase Physical Activity, Oral Health and Healthy Eating in Children Aged 2–4 years. Oral Presentation. Victoria, BC: ISBNPA conference 2017; 2017.

Kipping R, Langford R, White J, Metcalfe C, Papadaki A, Hollingworth W, et al. NAP SACC UK: Feasibility Cluster Randomised Controlled Trial and Process Evaluation of an Environmental Intervention in Nurseries and a Web-Based Home Intervention to Increase Physical Activity, Oral Health and Healthy Eating in Children Aged 2–4 years. Poster Presentation. Manchester: Society of Social Medicine conference 2017; 2017.

Er V, Dias K, Papadaki A, White J, Metcalfe C, Jago R, et al. Are Diet and Physical Activity Associated with zBMI in 2–4-year olds in North Somerset and Gloucestershire: A Cross-Sectional Study. Oral Presentation. Bristol: South West Public Health Scientific Conference 2018; 2018.

Tinner L, Kipping R, White J, Jago R, Metcalfe C, Hollingworth W, et al. Are Quality of Life and Family Expenditure on Physical Activity Associated with Physical Activity in 2–4-year-olds in North Somerset and Gloucestershire? Oral Presentation. Bristol: South West Public Health Scientific Conference 2018; 2018.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health and Social Care.

Food served on a plate by staff and distributed to children

This approach is most common with younger children, in nurseries where meals are delivered by an external company and for hot meals. With this style it is possible to take the before-and-after photograph as children are unable to help themselves and photographs can often be taken before children start to eat the food. If any additional items are served throughout the meal, this can be captured in the observation sheet. For this approach, approximately 10 children from the same table can be followed by two researchers; one researcher takes the photographs and the other researcher makes notes about drinks and any additional items served on the observation sheet.

Food served on serving plates and bowls in the centre of the table for children to help themselves (to put onto their own plate)

This approach is more common with older children, although most are still assisted in serving themselves. It is usual with more substantial hot meals, such as lunch. For example, there might be a central plate with meat slices, another with potatoes and another with vegetables and the children use a spoon to serve themselves. In this case it is possible to take the before-and-after photograph as well as photographs for additional portions as it is rare that a child will be allowed more than two additional portions. Staff assistance is required to tell fieldworkers when a child is having an additional portion. The laminated card needs to be altered between portions, which can make the wait longer for the child. For this approach, up to eight children from one table can be followed by two researchers.

Food served at the table with platters in the centre for children to help themselves (either with or without their own plate)

This approach is most common with snacktimes and teatime (Figure 6). Nursery staff will have access to a fruit bowl or a trolley with the food on and will sit at the table with the children, chop up the food into portions and then put it in the middle of the table. In this case, it is possible only to take an ‘after’ photograph of the food to capture what is left over, the data must be captured through an observation sheet. Children may take several small portions and often they take from the central plate and eat straight away, without putting the food onto their own plate. It is therefore not feasible to take all before photographs for this type of serving.

FIGURE 6.

Photograph of food served on a platter at snacktime.

Food served in a rolling fashion

For some meals, some nurseries serve the children a few at a time. For example, four children may come to a small table and be served. Only once these children have finished and left the table are other children called to be served. If the food served is on a plate, it is possible to take photographs of all the children’s food as they are being served a few at a time. However, the style of the meal may still be ‘grazing’ with platters of different food in the middle, with the difference that children are called at different times. In this case the observation sheet can be used to record all items that were taken by the child and only the after photograph can be taken. This indicates how much food was not eaten. Rolling fashion serving takes longer than meals at which all children are served at the same time, but the researchers can capture a larger number of children.

Single identical item of food served to all children

In some meal occasions, one single identical item of food is served to all children (i.e. sealed yoghurt pot). On these occasions, the researchers can record an example photograph of the item and then record on the observation sheet who has been given this item. An after photograph can be taken to record how much of the item has been eaten and is left over.

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