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

Vereecken 2009.

Study characteristics
Methods Study design: cluster‐RCT
Length of follow‐up from baseline: 6 months
Unit of allocation: preschools
Unit of analysis: child
Participants Service type: centre‐based (preschools)
Operation: not reported
Country (region): Belgium (Flanders)
Country income classification: high
Low‐SES sample: unclear
Population description: not reported
Inclusion criteria: not reported
Exclusion criteria: not reported
Number of services randomised: 16 (8 intervention, 8 control)
Number of children randomised: 1432 (867 intervention, 565 control) at baseline
Characteristics
Children
Age:
Intervention year of birth: < 2002: 41%; 2002: 28%; ≥ 2003: 31%
Control year of birth: < 2002: 51%; 2002: 24%; ≥ 2003: 26%.
Gender (% female):
Intervention: 53%
Control girls: 44%
Ethnicity: not reported
Parents
Age (years): not reported
Gender (% female):
Intervention: 94%
Control: 95%
Ethnicity: not reported
Parent/family SES:
Mothers' education
Intervention: low (secondary school or less): 49%; medium (Bachelor): 34%; high (Bachelor with supplementary education or Masters): 16%
Control: low (secondary school or less): 49%; medium (Bachelor): 35%; high: (Bachelor with supplementary education or Masters): 16%
Fathers' education
Intervention: low (secondary school or less): 60%; medium (Bachelor): 22%; high (Bachelor with supplementary education or Masters): 18%
Control: low (secondary school or less): 57%; medium (Bachelor): 26%; high (Bachelor with supplementary education or Masters): 17%
Method of recruitment: schools were asked by mail if they would be willing to participate in an intervention study to promote healthy eating.
Missing data/dropout: 46% returned a completed questionnaire at follow‐up
Reasons for dropout: not reported
Characteristics of dropouts: not reported
Interventions Programme name: Beastly Healthy at School
Number of conditions: 1 intervention, 1 control
Intervention duration: 6 months
Intervention setting: ECEC and home
Intervention strategies:
Health curriculum
Children
Education: developmental education (e.g. explanation of concepts of food triangle)
Ethos and environment
Children
Exposure: guided and self‐guided activities based on experiential education (e.g. tasting). Healthy foods made available to children
Support: role model, feedback and reinforcement by teachers
Resources: cooking equipment made available to children (for use under supervision)
ECEC staff
Training: 2 x full‐day training sessions for principals and cafeteria staff
Resources: an educational package, including an educational map for the teachers, an educative story and educational material (e.g. life‐size food education model based on the Flemish “Active Food Triangle”) was developed. Food messages and newsletters directed at the school staff were provided. A digital learning environment was provided.
Support: group discussions with teachers; help on demand via email; examples of good practices.
Audit and feedback: feedback provided to schools.
Partnerships
Families
Resources: parents were provided with food messages and newsletters, and work sheets and creations by children.
Activities/meetings: parent evenings and other school activities with parents
Intensity of intervention: 2 d staff training; support on demand was offered via email; child curriculum (frequency and duration not reported)
Intervention delivered by: research team, ECEC staff
Modality: face‐to‐face, online, written
Theoretical basis: The Intervention Mapping Protocol
Description of control: usual care
Outcomes Outcomes relating to child dietary intake:
Water intake, fruit juice intake, sugared soft drinks intake, sugared milks intake, milk intake, fresh fruit intake, snacks intake, vegetable intake
Number of participants analysed:
Intervention baseline: 308‐618
Intervention follow‐up: 308‐618
Control baseline: 168‐445
Control follow‐up: 168‐445
Data collection measure: FFQ and teachers' audit
Data collector: parent and teacher
Validity of measures used: validated (FFQ) and not reported (teachers audit)
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: the development of the intervention was funded by the PWO (Project‐related Scientific Research)‐funding of University College Arteveldehogeschool. Funds for the evaluation were provided by the Provincial Government East‐Flanders. Carine Vereecken is a postdoctoral researcher funded by the Research Foundation–Flanders (FWO–Flanders).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk 8 control and 8 intervention schools were randomly selected and stratified on school authority, location, and size of the school. For 1 school in the intervention group, 3 departments at different locations participated. The sequence generation procedure was not described.
Allocation concealment (selection bias) Low risk Recruitment materials indicated there was a 50% chance that schools be randomised to the control group.
Blinding of participants and personnel (performance bias)
Diet outcomes High risk We assumed that due to the nature of the intervention, ECEC service staff and study personnel delivering the intervention were not blind to the study allocation. The outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
Diet outcomes High risk Parents reported children's dietary intake, and data on available snacks and drinks were recorded by the teachers on a pre‐defined list. Parents and teachers were not blinded to treatment allocation and the outcome measurement is likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias)
Diet outcomes High risk Study authors stated that "Of all children approached at baseline (n = 1432) and follow‐up (1637), respectively 884 (62%) and 761 (46%) returned a completed questionnaire; of whom 570 could be matched. Only those completed by the same respondent at both measurement occasions were kept for analyses: 308 intervention children and 168 control children." Due to the magnitude of missing data, the risk of bias was assessed as high.
Selective reporting (reporting bias) Unclear risk No prospective trial protocol or trial registration so it was unclear whether there was selective outcome reporting.
Recruitment bias Unclear risk It is unclear whether individuals were recruited to the study before or after randomisation of clusters.
Baseline imbalance Unclear risk Study authors state that "The control group contained considerably (borderline significantly) more boys and children from the youngest age group." Analyses of the FFQs were controlled for gender of the child and year of birth, however no other baseline data were reported (only gender, year of birth, education of mother and father, and who completed the FFQ were reported). There may be unmeasured differences between groups.
Loss of clusters Unclear risk Not reported
Incorrect analysis Unclear risk Study authors stated that "Linear mixed models (SPSS 15.0) were used to investigate the effect of the condition on changes in consumption and food policy aspects." No further information is provided. There is not enough information to assess whether an important risk of bias exists.
Contamination Unclear risk No evidence to make assessment
Other bias Unclear risk No conflict of interest statement was reported.