Kipping 2019.

Study characteristics
Methods	Study design: cluster‐RCT Length of follow‐up from baseline: 8‐10 months Unit of allocation: nurseries Unit of analysis: child
Participants	Service type: centre‐based (preschools, day nurseries and centre nurseries) Operation: combination of community and private Country (region): UK (North Somerset and Gloucestershire ) Country income classification: high Low‐SES sample: no Population description: the study took place in nurseries in 2 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 (percent of children aged < 16 years in families receiving means‐tested benefits and low income in 2012). 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. Inclusion criteria: child‐care providers must be a day nursery, private nursery school, maintained nursery school, children’s centre with nursery, or preschool, in North Somerset or Gloucestershire. 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 h/week over 50 weeks of the year, or 15 h/week in term time. Exclusion criteria: 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. Number of services randomised: 12 (6 intervention, 6 control) Number of children randomised: 476 (86 participated intervention, 91 participated control) Characteristics Children Age: 2‐4 year olds Gender (% female): not reported Ethnicity: not reported Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: not reported Method of recruitment: ECEC providers were sent a letter from the Council, project information sheet, reply envelope and form indicating if they wished to participate and reason for their response. Non‐responders were followed up with a reminder and then a telephone call. All interested ECEC 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 GBP 200 incentive was provided to all participating nurseries at the end of the study. Missing data/dropout: at the follow‐up data collection, 147 (87.5%) out of 168 children at baseline participated in data collection. Out of the 476 potentially eligible children at baseline, 147 (30.9%) children provided data at baseline and follow‐up. Reasons for dropout: 2 (1.2%) children had consent withdrawn, 2 (1.2%) refused to participate in measurements and their parents did not return follow‐up questionnaires, 8 (4.8%) moved nursery and 9 (5.4%) moved to primary school and did not take up the offer to continue participation. Characteristics of dropouts: not reported
Interventions	Programme name: NAP SACC UK ((The Nutrition And Physical Activity Self‐Assessment for Child Care UK) Number of conditions: 1 intervention, 1 control Intervention duration: 5 months Intervention setting: ECEC and home Intervention strategies: Ethos and environment ECEC staff Workshop: specialised staff delivered 2 workshops to the nursery staff on nutrition, oral health and physical activity. Action planning: the NAP SACC UK partners worked with the nursery manager to set out an action plan, listing 8 goals for improvement. These were 3 nutrition goals, 3 physical activity goals and 2 further goals of their choice. The NAP SACC partner helped the nursery manager agree how and when these goals will be reached. Support: intervention partners continued regular contact with nursery (via telephone, email or in person), providing support and advice to help the nursery meet their goals. Self‐monitoring: 'Review and reflect' process of self‐assessment to see where improvements were made. Where improvements were not made, reasons why were discussed to help overcome barriers. Action plans were revised to set new goals. Service Policy: nursery staff were supported to review the nutrition, oral health, physical activity and screen time environment, policies and practices against best practice and national guidelines. Partnerships Families Resources: parents were given access to the NAP SACC at home website to complete healthy habits forms and set goals. As an incentive, the first 50 parents to register received a swimming voucher to the local pool. Support: parents received tailored texts/emails giving them suggestions or areas to set goals. Partners Workshop: a 2‐2.5 h training session was delivered to partners. Support: intervention partners provided support and advice to help the nursery meet their goals. Intensity of intervention: initial staff meetings lasted for > 2 h (between the health visitor and nursery manager); average number of advice/support opportunities was 2.2 face‐to‐face meetings, 1.8 telephone calls and 2.8 emails. 2 x workshops delivered to nursery staff by local experts in nutrition (3 h) and physical activity (2.5 h); a home component (website, short message service and emails) was developed to support parents in setting goal, they could assess this as often as they liked (tailored text messages or emails were sent to parents on a fortnightly basis). Intervention delivered by: research team Modality: face‐to‐face, telephone, online, written Theoretical basis: Social Cognitive Theory and the Socioeconomic Framework Description of control: usual care
Outcomes	Outcomes relating to child dietary intake: Types of fruit and vegetable intake; meat, fish, eggs, beans and other non‐dairy sources of protein intake; desserts, puddings and cakes intake; beverages intake; starchy food intake Number of participants analysed: Intervention baseline: 13‐30 Intervention follow‐up: 13‐30 Control baseline: 12‐27 Control follow‐up: 12‐27 Data collection measure: child and Diet Evaluation Tool (CADET) Data collector: trained observer Validity of measures used: validated Outcomes relating to child physical measures: BMI z‐score, weight, overweight or obese, obese Number of participants analysed: Intervention baseline: 30‐58 Intervention follow‐up: 30‐58 Control baseline: 18‐76 Control follow‐up: 18‐76 Data collection measure: objectively measured (UK, 1990 age and gender growth reference charts and International Obesity Task Force (IOTF) reference points) Data collector: trained field workers Validity of measures used: not reported Outcome relating to child language and cognitive performance: not reported Outcome relating to child social/emotional measures: not reported Outcome relating to child quality of life: Quality of life (total, physical function, emotional function, social function, nursery function) Number of participants analysed: Intervention baseline: 32 Intervention follow‐up: 32 Control baseline: 45 Control follow‐up: 45 Data collection measure: Paediatric Quality of Life Inventory (PedsQL) 4.0 Data collector: parent Validity of measures used: validated Outcome relating to cost: Average cost of health visitor intervention delivery per nursery (including workshop), average cost of intervention to nursery, parental weekly food spend Number of participants analysed: not reported Data collection measure: nursery logs and parent‐completed questionnaire Data collector: unclear and parent Validity of measures used: not reported Outcome relating to adverse consequences: Incident or adverse event Number of participants analysed: not reported Data collection measure: nursery managers and those delivering the intervention were asked to contact the study team within 5 working days if any untoward incident or adverse event occurred to a member of staff or child as a result of the intervention Data collector: nursery managers and those delivering the intervention Validity of measures used: not reported
Notes	Funding source: North Somerset Council and Gloucestershire Council. Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer). Elizabeth Blackwell Institute (University of Bristol) and the Wellcome Trust. Medical Research Council (MRC) and from the Scottish Government Chief Scientist Office
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	ECEC providers were stratified by geographic area, deprivation of location, and size of provider and randomised to the control or intervention groups. Allocation was conducted by an independent statistician at the Bristol Randomised Trials Collaboration, blind to the identity of the ECEC providers.
Allocation concealment (selection bias)	Low risk	Allocation was conducted by an independent statistician who was blind to the identity of the ECEC providers.
Blinding of participants and personnel (performance bias) Diet outcomes	High risk	No clear blinding of participants and personnel to study allocation, and the outcome is likely to be influenced by lack of blinding.
Blinding of participants and personnel (performance bias) Physical outcomes	Low risk	No clear blinding of participants and personnel to study allocation, however the outcome is not likely to be influenced by lack of blinding.
Blinding of participants and personnel (performance bias) Quality of life outcomes	High risk	No clear blinding of participants and personnel to study allocation, and the outcome is likely to be influenced by lack of blinding.
Blinding of participants and personnel (performance bias) Cost	Unclear risk	No clear blinding of participants and personnel to study allocation. It is unclear whether the outcome is likely to be influenced by lack of blinding.
Blinding of participants and personnel (performance bias) Adverse consequences	Unclear risk	No clear blinding of participants and personnel to study allocation. It is unclear whether the outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Diet outcomes	High risk	Dietary intake data were reported by researcher observers and parents using the Child and Diet Evaluation Tool (CADET). Blinding of parents and researchers not reported, and the outcome measurement is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Physical outcomes	Low risk	Blinding not reported, however children's height and weight were measured by trained field workers with a member of nursery staff present and the outcome measurements are not likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Quality of life outcomes	High risk	Parents reported children's functioning using the Paediatric Quality of Life Inventory 4.0. Blinding of parents not reported, and the outcome measurement is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Cost	Unclear risk	No clear blinding of participants and personnel to study allocation. It is unclear whether the outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) Adverse consequences	Unclear risk	No clear blinding of participants and personnel to study allocation. It is unclear whether the outcome is likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) Diet outcomes	High risk	CADET nursery data are available for 130 (85%) children at follow‐up, while CADET home data are available for 79 (57%) children at follow‐up. Due to the magnitude of missing data and difference in the proportions of participants followed up between groups, the risk of bias was assessed as high.
Incomplete outcome data (attrition bias) Physical outcomes	High risk	In the intervention group, 81 children were analysed at baseline, however only 41 (51%) had BMI z‐score data at follow‐up. In the control group, 86 children were analysed at baseline, however only 56 (65%) had BMI z‐score data at follow‐up. Due to the magnitude of missing data, the risk of bias was assessed as high.
Incomplete outcome data (attrition bias) Quality of life outcomes	High risk	Study authors stated that "A total of 124 parents (72.1%) completed the questionnaire about the child's quality of life, expenditure on food and physical activity and child health‐care use at baseline. A total of 86 parents (50%) completed the questionnaire at follow‐up. The complete case for HRQoL [health‐related quality of life] analysis was 77 (44.8%)." Due to the magnitude of missing data, the risk of bias was assessed as high.
Incomplete outcome data (attrition bias) Cost	High risk	Data were available for 86 (51.8%) of parents at follow‐up and 12 services did not take part in the whole intervention, indicating high attrition.
Incomplete outcome data (attrition bias) Adverse consequences	Unclear risk	The number of services and participants that reported on this outcome at follow‐up is unclear.
Selective reporting (reporting bias)	Low risk	The outcomes reported in the paper were prespecified in the protocol paper.
Recruitment bias	High risk	Centres were allocated prior to individual recruitment, and thus an individual knew if the school was receiving the intervention or control prior to signing up.
Baseline imbalance	Unclear risk	Baseline differences are noted, although it is unclear if these differences are statistically significant. Study authors state that "Stratified randomisation was used to ensure balance for (1) deprivation... (2) size of child‐care provider...and (3) location."
Loss of clusters	High risk	One cluster did not fully implement the intervention, and it is unclear what happened with these data and the children from this centre. All analyses are descriptive.
Incorrect analysis	High risk	There was no accounting for clustering of children within nurseries.
Contamination	Unclear risk	No evidence to make assessment
Other bias	Low risk	No clear other source of bias