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. 2023 Jun 12;2023(6):CD013862. doi: 10.1002/14651858.CD013862.pub2

Lerner‐Geva 2014.

Study characteristics
Methods Study design: cluster‐RCT
Length of follow‐up from baseline: 4 months
Unit of allocation: kindergartens
Unit of analysis: child
Participants Service type: centre‐based (kindergartens)
Operation: not reported
Country (region): Israel (Ra'anaana)
Country income classification: high
Low‐SES sample: no
Population description: Ra’anaana is placed in the second highest rank of socioeconomic clusters of the population.
Inclusion criteria: the study population comprised children aged 4–6 years attending full‐day kindergartens in the city of Ra’anaana. Kindergartens considered for inclusion were those that ran a full‐day programme until 16:00 h, which all received lunch from the same catering service and had the same standard of physical exercise of 1 h/week.
Exclusion criteria: not reported
Number of services randomised: 6 (2 Intervention 1; 2 Intervention 2; 2 control)
Number of children randomised: 204 (69 Intervention 1; 67 Intervention 2; 68 control)
Characteristics
Children
Age:
Intervention 1: ≤ 4 years, 31.9%; 5‐6 years, 43.5%; ≥ 6 years, 24.6%
Intervention 2: ≤ 4 years, 23.9%; 5‐6 years, 43.3%; ≥ 6 years, 32.8%
Control: ≤ 4 years, 10.3%; 5‐6 years, 61.8%; ≥ 6 years, 27.9%
Gender (% female):
Intervention 1: 46.4%
Intervention 2: 55.2%
Control: 45.5%
Ethnicity:
Intervention 1: birthplace ‐ Israel: 91.3%; other: 8.7%
Intervention 2: birthplace ‐ Israel: 98.5%; other: 1.5%
Control: birthplace ‐ Israel: 95.4%; other: 4.6%
Parents
Age (years): not reported
Gender (% female): not reported
Ethnicity:
Intervention 1: both parents born in Israel, 60.3%; 1 parent born in Israel, 26.5%; both parents born overseas, 13.2%
Intervention 2: both parents born in Israel, 73.4%; 1 parent born in Israel, 17.2%; both parents born overseas, 9.4%
Control: both parents born in Israel, 64.2%; 1 parent born in Israel, 23.9%; both parents born overseas, 11.0%
Parent/family SES:
Parent education: intervention 1: both ≥ 13 years, 74.6%; 1 ≥ 13 years, 12.7%; both < 13 years, 12.7%
Intervention 2: both ≥ 13 years, 62.7%; 1 ≥ 13 years, 20.3%; both < 13 years, 17.0%
Control: both ≥ 13 years, 89.1%; 1 ≥ 13 years,, 24.7%; both < 13 years, 6.2%
Method of recruitment: 6 kindergartens were randomly approached to participate in the programme.
Missing data/dropout: not reported
Reasons for dropout: not reported
Characteristics of dropouts: not reported
Interventions Programme name: It Fits Me: adapted for kindergarten children
Number of conditions: 2 interventions, 1 control
Intervention duration: intervention 1: 4 months; Intervention 2: 10 weeks
Intervention setting: ECEC
Intervention strategies:
Intervention 1: full interventionHealth curriculumChildren
Education: 10 lessons on healthy eating delivered by teachers
Ethos and environmentChildren
Exposure: a daily exercise programme (5 d/week) for 30 min in the morning, delivered by a teacher of physical education who had undergone training.
ECEC staff
Training: teachers were given training by attending lectures where they were familiarised with the materials, in order to facilitate their ability to perform the lessons in their classes.
Resources: supporting materials included posters, worksheets, games, colouring‐in sheets and instruction materials for teachers.
Families
Resources: a summary for parents about each nutrition lesson was provided to reinforce messages.
Intervention 2: partial interventionHealth curriculumChildren
Education: 10 lessons on healthy eating delivered by teachers
Ethos and environmentECEC staff
Training: teachers were given training by attending lectures where they were familiarised with the materials, in order to facilitate their ability to perform the lessons in their classes.
Resources: supporting materials included posters, worksheets, games, colouring‐in sheets and instruction materials for teachers.
Families
Resources: a summary for parents about each nutrition lesson was provided to reinforce messages.
Intensity of intervention:
Intervention 1: 1 x healthy eating lesson/week for 10 weeks; 30‐min physical activity class daily from March‐June; teachers attended training lecture (frequency and duration not reported)
Intervention 2: 1 x healthy eating lesson/week for 10 weeks; teachers attended training lecture (frequency and duration not reported)
Intervention delivered by:
Intervention 1: research team, ECEC staff
Intervention 2: research team, ECEC staff
Modality:
Intervention 1: face‐to‐face, written
Intervention 2: face‐to‐face, written
Theoretical basis: not reported
Description of control: usual care
Outcomes Outcomes relating to child dietary intake:
Daily energy intake
Number of participants analysed:
Intervention 1 baseline: 69
Intervention 1 follow‐up: 69
Intervention 2 baseline: 67
Intervention 2 follow‐up: 67
Control baseline: 68
Control follow‐up: 68
Data collection measure: FFQ and 24‐h recall questionnaire
Data collector: parents
Validity of measures used: validated
Outcomes relating to child physical measures:
BMI z‐score
Number of participants analysed:
Intervention 1 baseline: 69
Intervention 1 follow‐up: 69
Intervention 2 baseline: 67
Intervention 2 follow‐up: 67
Control baseline: 68
Control follow‐up: 68
Data collection measure: objectively measured (CDC)
Data collector: researcher
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: not reported
Outcome relating to cost: not reported
Outcome relating to adverse consequences: not reported
Notes Funding source: this research received no specific grant from any funding agency in the public, commercial or not‐for‐profit sector.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The random sequence generation procedure was not described.
Allocation concealment (selection bias) Unclear risk No information on the method of allocation concealment reported.
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 outcome assessment (detection bias)
Diet outcomes High risk Parents reported children's dietary intake via a quantified FFQ outside of school, and a helper completed a structured form to document children's intake during school. Blinding of parents and helpers 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 a single investigator and the outcome measurements were not likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias)
Diet outcomes Unclear risk The number of students available at follow‐up is not reported, so risk of attrition bias is unclear.
Incomplete outcome data (attrition bias)
Physical outcomes Unclear risk The number of students available at follow‐up is not reported, so risk of attrition bias is unclear.
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 Low risk Parental consent was obtained at the beginning of the programme. All parents were invited to an information evening at the beginning of the programme, where they received an explanation of the research without knowing to which group their child would be allocated.
Baseline imbalance Low risk Baseline differences between groups were found for age of children, parents' education, and religious level. Analysis accounted for these differences
Loss of clusters Unclear risk Not reported
Incorrect analysis Low risk Study authors stated that "Each model included fixed effects: baseline measures, age, parents' education, religious status, study group and random effect of kindergarten and child."
Contamination Unclear risk No evidence to make assessment
Other bias Low risk No clear other source of bias