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 |
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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 |
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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 intervention Health curriculum Children Education: 10 lessons on healthy eating delivered by teachers Ethos and environment Children 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 intervention Health curriculum Children Education: 10 lessons on healthy eating delivered by teachers Ethos and environment 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. 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 |
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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 |
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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 |