During the funding process, NIHR suggested that an urban area with greater ethnic diversity be included in addition to North Somerset to ensure greater generalisability. The plan was to keep Bristol available for a full trial and, therefore, we proposed that Cardiff be involved. There was subsequently a change of site from Cardiff to Gloucestershire, which required a protocol amendment. Full details of this decision are shown in Table 30, Appendix 1. This was agreed with the sponsor, TSC and NIHR. The collaborators’ agreement was signed by the two new organisations. This created a delay in recruitment of nurseries in Gloucestershire, but the change improved our understanding of the feasibility of undertaking this study by involving another local authority area in England given the complexity of interventions and different nursery provision encountered in Wales.
Shortening the intervention
As recruitment of nurseries was delayed by the change to include Gloucestershire, we agreed with the TSC to shorten the intervention to 5 months. Therefore, baseline data collection was carried out from September 2015 to January 2016. Randomisation took place in February 2016. The intervention period was 1 February 2016 to 30 June 2016. The NAP SACC UK at Home element was launched to parents in April and May 2016. Follow-up data collection was completed at 8 out of the 12 nurseries in July 2016. The remaining four nurseries were left until September 2016 to assess the feasibility of following up those children who had left nursery to start school.
Chapter 3 Feasibility study phase 1: methods
T
his chapter provides an overview of the study aims and objectives, study design, methods and results of phase 1 of the study where we adapted NAP SACC to the UK setting and developed a home component.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.68Each 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.
Feasibility study phase 1: results
This chapter presents the results from phase 1 of the feasibility study, which aimed to inform the adaptation of the NAP SACC intervention for use in the UK and the creation of a home component and to refine the RCT methods.
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.
Child-care context
Table 3 shows the breakdown of nurseries by location, socioeconomic status (SES), type of nursery, number of 2- to 4-year-old children registered at the nursery, and meal and/or snack provision. The SES of the nursery was based on the Index of Multiple Deprivation (IMD)69in England and the Welsh Index of Multiple
Deprivation (WIMD)70in Wales. The IMD is an English Government-produced measure of deprivation that
includes assessments of income, employment, health and education.69WIMD is the official measure of
relative deprivation for small areas in Wales, which includes assessments of income, employment, health, education, access to services, community safety, physical environment and housing.70The IMD/WIMD was
obtained for the postcode of each nursery and thus represented a measure of deprivation for the nursery and not the individual participant. The nurseries were then stratified into low-, middle- and high-SES tertiles.
TABLE 2 Phase 1 participant characteristics
Place Group
Number
Total In focus groups Of interviews
North Somerset Parents (all) N/A 21 21
Low-SES parents N/A 1 1
Middle-SES parents N/A 12 12
High-SES parents N/A 8 8
Nursery managers 2 6 8
Public health/early years staffa 6 N/A 6
Cardiff Parents N/A 10 10
Low-SES parents N/A 0 0
Middle-SES parents N/A 5 5
High-SES parents N/A 5 5
Nursery managers N/A 4 4
Public health/early years staffb 9 N/A 9
Total Parents (all) N/A 31 31
Nursery managers 2 10 12
Public health/early years staffb
15 N/A 15
N/A, not applicable.
a North Somerset health visitors, North Somerset nursery staff members, North Somerset public health and early years staff members.
b WHASPS, Welsh Healthy Preschool Programme Staff members and Cardiff Council members.
TABLE 3 Phase 1 characteristics of child-care settings Child-care setting number Location of child-care setting SES of child-care setting Type of child-care setting Number of 2- to 4-year-old children
at child-care setting Food provided
1 North Somerset High Community preschool 40 Meals and snacks
2 North Somerset High Community preschool 16 Snack only
3 North Somerset Middle Private day nursery 48 Meals and snacks
4 North Somerset Middle Children’s centre nursery 105 Meals and snacks
5 North Somerset High Community preschool 45 Snack only
6 North Somerset Low Private day nursery 35 Meals and snacks
7 North Somerset Middle Private day nursery 60 Meals and snacks
8 North Somerset Middle Private day nursery 42 Meals and snacks
9 Cardiff High Private day nursery 50 Meals and snacks
10 Cardiff Low Private day nursery 30 Meals and snacks
11 Cardiff Middle Private day nursery 63 Meals and snacks
Eight nurseries were based in North Somerset, of which four were registered as private day nurseries, three as community preschools and one as a children’s centre nursery. Four nurseries were based in Cardiff, of which three were registered as private day nurseries and one as a community preschool. Across both sites, two nurseries were classified as low SES, five were middle SES and five were high SES. The number of 2- to 4-year-old children registered at the nurseries ranged from 16 to 105. A total of 75% of the sample of nurseries provided meals and snacks for children, which were prepared in-house. The remainder, all of which were community preschools offering sessional care, provided snacks only. Information regarding the ethnic diversity of the child-care settings was unavailable but one-third of the nurseries were based in Cardiff, which is ethnically diverse (17.2% from a non-white background).70