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. 2023 Aug 22;2023(8):CD013862. doi: 10.1002/14651858.CD013862.pub3

Nekitsing 2019a.

Study characteristics
Methods Study design: cluster‐RCT (2 x 2 factorial design)
Length of follow‐up from baseline: 12 weeks
Unit of allocation: preschools
Unit of analysis: child
Participants Service type: centre‐based (preschools)
Operation: not reported
Country (region): UK (Leeds, Brighouse, and Halifax)
Country income classification: high
Low‐SES sample: unclear
Population description: not reported
Inclusion criteria: preschools were eligible to take part in the case that they were not participating in other nutrition health programmes and were able to commit to the time frame of the study (9 months). All children aged 2‐5 years attending their preschool class on the agreed test day were included.
Exclusion criteria: children were excluded from the study in the case that they had any relevant food allergies, a medical condition that would prevent them from eating the test vegetable, or if their parents opted out of the study.
Number of services randomised: 11 (2 Intervention 1; 3 Intervention 2; 3 Intervention 3; 3 control)
Number of children randomised: 219 (62 Intervention 1; 68 Intervention 2; 55 Intervention 3; 34 control)
Characteristics
Children
Age:
Intervention 1: 38.11 months (SD 0.83)
Intervention 2: 43.42 months (SD: 0.54)
Intervention 3: 40.54 months (SD 0.65)
Control: 41.75 months (SD 0.87)
Gender (% female):
Intervention 1: 51.1%
Intervention 2: 52.1%
Intervention 3: 64.1%
Control: 37.5%
Ethnicity: not reported
Parents
Age (years): not reported
Gender (% female): not reported
Ethnicity: not reported
Parent/family SES: not reported
Method of recruitment: 55 preschools from Leeds, Brighouse, and Halifax (West Yorkshire, UK) were sent a recruitment e‐mail in July 2016, followed by a telephone call.
Missing data/dropout: lost at baseline: intervention 1: 0/62; Intervention 2: 11/68; Intervention 3: 0/55; Control: 2/34
Lost at follow‐up: intervention 1: 2/62; Intervention 2: 4/68; Intervention 3: 2/55; Control: 3/34
Reasons for dropout: children missed intake assessment days
Characteristics of dropouts: no differences were found in baseline characteristics or intake of the children who were lost to follow‐up compared with those who completed the study.
Interventions Programme name: not reported
Number of conditions: 3 interventions, 1 control
Intervention duration: 10 weeks
Intervention setting: ECEC
Intervention strategies:
Intervention 1: Taste exposure
Ethos and environmentChildren
Exposure: ECEC staff offered children mooli (40‐g portions) during usual snack time once/week, for 10 weeks.
Intervention 2: Nutrition education
Health curriculumChildren
Education: staff members were instructed to teach 2 specific components of the PhunkyFood Program as often as possible during the 10‐week period.
Ethos and environment
ECEC staff
Training: staff members were trained to deliver the existing PhunkyFoods program.
Resources: ideas and inspiration for classroom carousel play activities (e.g. stories, role‐play, and games), practical food handling/preparation activities, educational displays for the classroom and parental involvement opportunities. Resources were available in both online and offline formats. Staff members were given materials to support their teaching (e.g. photo cards, posters, a floor mat, game ideas, interactive video stories, music, food preparation, tasting ideas, and drawing and colouring activities).
Partnerships
External provider
Delivery: The PhunkyFoods team trained educators.
Intervention 3: Taste Exposure + Nutrition Education
Health curriculumChildren
Education: staff members were instructed to teach 2 specific components of the PhunkyFood Program as often as possible during the 10‐week period.
Ethos and environmentChildren
Exposure: ECEC staff offered children mooli (40‐g portions) during usual snack time once/week, for 10 weeks.
ECEC staff
Training: staff members were trained by the PhunkyFoods team to deliver the existing PhunkyFoods program.
Resources: ideas and inspiration for classroom carousel play activities (e.g. stories, role‐play, and games), practical food handling/preparation activities, educational displays for the classroom and parental involvement opportunities. Resources were available in both online and offline formats. Staff members were given materials to support their teaching (e.g. photo cards, posters, a floor mat, game ideas, interactive video stories, music, food preparation, tasting ideas, and drawing and colouring activities).
Partnerships
External provider
Delivery: The PhunkyFoods team trained educators.
Intensity of intervention:
Intervention 1: children were offered 40‐g portions of the vegetable snack once/week for 10 weeks.
Invervention 2: staff trained in PhunkyFoods; 2 specific components of the PhunkyFood Program delivered to children as often as possible during the 10‐week period
Intervention 3: children were offered 40‐g portions of the vegetable snack once a week for 10 weeks; staff trained in PhunkyFoods; 2 specific components of the PhunkyFood Program delivered to children as often as possible during the 10‐week period.
Intervention delivered by:
Intervention 1: research team, ECEC staff
Intervention 2: ECEC staff, healthcare staff
Intervention 3: research team, ECEC staff, healthcare staff
Modality:
Intervention 1: face‐to‐face
Intervention 2: face‐to‐face, online, written
Intervention 3: face‐to‐face, online, written
Theoretical basis: not reported
Description of control: usual care
Outcomes Outcomes relating to child dietary intake:
Intake of test vegetable (mooli)
Number of participants analysed:
Intervention 1 baseline: 32‐47
Intervention 1 follow‐up: 44‐47
Intervention 2 baseline: 31‐38
Intervention 2 follow‐up: 38
Intervention 3 baseline: 25‐29
Intervention 3 follow‐up: 25‐39
Control baseline: 12‐16
Control follow‐up: 12‐16
Data collection measure: each vegetable portion was weighed before and after each snack time using a digital scale
Data collector: researcher
Validity of measures used: not reported
Outcomes relating to child physical measures:
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: not reported
Outcome relating to cost: not reported
Outcome relating to adverse consequences: not reported
Notes Funding source: White Rose Doctoral Training Centre (WRDTC) Economic and Social Research Council (ESRC) Collaborative Award. The collaborative partner is Purely Nutrition Ltd. Contribution in kind, which includes storybooks and photo cards, were received from Purely Nutrition Ltd.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Preschools were stratified by size and randomly assigned to one of 4 intervention conditions using an online list generator (https://www.random.org/lists).
Allocation concealment (selection bias) Low risk Preschool managers were not informed of their condition allocation until all preschools were recruited (after consent) and randomised. It was possible to conceal condition allocation between clusters but not within a cluster.
Blinding of participants and personnel (performance bias)
Diet outcomes High risk Teachers were aware of allocation and could have encouraged students to eat or try more of the vegetable on testing days.
Blinding of outcome assessment (detection bias)
Diet outcomes Low risk Blinding not reported, however vegetable portions were measured before and after intake to the nearest 0.01 g to determine consumption. The outcome measurement is not likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias)
Diet outcomes High risk Data were available for 140 (64%) children allocated to a treatment group at follow‐up, with follow‐up rates between 47%‐76% across the 4 groups. Study authors stated that "due to the nature of the study design there was a high rate of missing data over time for the complete set of intake data, including follow‐ups (36%). As a result of this, there was a substantially smaller sample size in the control condition" 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.
Selective reporting (reporting bias) Unclear risk Trial registered with primary outcome reported as described. Secondary outcome measure of intake of usual vegetables, however this outcome was not reported in the study.
Recruitment bias Low risk Individuals and schools were recruited before randomisation of clusters. Study authors state that "Preschool managers were not informed of their condition allocation until all preschools were recruited (after consent) and randomized. It was possible to conceal condition allocation between clusters but not within a cluster."
Baseline imbalance Low risk No baseline differences noted between groups with regards to sex distribution or mean BMI z‐score, but there were differences in mean age. Age was controlled for in analyses.
Loss of clusters Low risk No loss of clusters
Incorrect analysis Low risk Study authors stated that "Because children were recruited using a cluster design, it was important to account for the influence of cluster assignment. In addition, for repeated measures, each data point was clustered within child. Therefore all the models described below corrected for this using the complex samples procedure within SPSS version 24 to incorporate the contribution of these variance components to the data."
Contamination Unclear risk No evidence to make assessment
Other bias Unclear risk Deviation from methods noted. Study authors stated that "However, given that many children did not eat mooli at baseline, the data were significantly skewed and not suited to simple parametric analysis. Therefore, children were categorized according to their eating pattern at postintervention, Follow‐up 1 and Follow‐up 2 (noneater, eater) and these are shown in Table 2." There is insufficient information to assess whether an important risk of bias exists. A commercial organisation provided in‐kind support.