Eliakim 2007.
Study characteristics | ||
Methods |
Study design: cluster‐RCT Length of follow‐up from baseline: 14 weeks Unit of allocation: preschool class Unit of analysis: child |
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Participants |
Service type: centre‐based (preschool) Operation: not reported Country (region): Israel (Oranit) Country income classification: high Low‐SES sample: no Population description: an upper‐middle SES community Inclusion criteria: the study included all 4 preschool classes in the community of Oranit, Israel. Children were included after their parents signed an informed consent form. Exclusion criteria: not reported Number of services randomised: 4 (2 interventions, 2 control) Number of children randomised: 118 Characteristics Children Age: Intervention: 66 months (SD 0.6) Control: 67 months (SD 0.7) Gender (% female): Intervention: 39% Control: 47% Ethnicity: not reported Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: not reported Method of recruitment: not reported Missing data/dropout: no dropout during the intervention period Reasons for dropout: not applicable Characteristics of dropouts: not applicable |
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Interventions |
Programme name: not reported Number of conditions: 1 intervention, 1 control Intervention duration: 14 weeks (4 months) Intervention setting: ECEC Intervention strategies: Health curriculum Children Education: integrating nutritional topics, such as basic knowledge about major food groups and the food pyramid, vitamins, food choices, food preparation and cooking methods, fast food vs home cooking, and drinking and eating habits into the current curriculum. Topics were taught through short lectures/talks, games and book reading. Children were encouraged to reduce sedentary activities and increase after‐school activity. Ethos and environment Children Exposure: children participated in 45 min/d exercise training (6 d/week), primarily in the form of games. Resources: children received dietary information using work sheets/flyers. ECEC staff Training: the intervention group preschool teachers were instructed so that all the nutritional aspects of the intervention and the majority of exercise classes were performed by the preschool staff. Partnerships Healthcare Delivery: twice a week, physical activity training was directed by a professional youth coach. Intensity of intervention: preschool teachers instructed so they could deliver the intervention; 2 x parent orientation lectures; nutrition education (intensity not reported); exercise training 45 min/d, 6 d/week Intervention delivered by: research team, ECEC staff, healthcare Modality: face‐to‐face, written Theoretical basis: not reported Description of control: usual care, plus parents were invited for 2 orientation lectures (childhood obesity and beneficial effects of exercise in children) during the first 2 months of the programme |
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Outcomes |
Outcomes relating to child dietary intake: not reported Outcomes relating to child physical measures: Weight, BMI, BMI percentile, body fat percentage, obese, overweight, overweight or obese Number of participants analysed: Intervention baseline: 54 Intervention follow‐up: 54 Control baseline: 47 Control follow‐up: 47 Data collection measure: objectively measured (CDC) Data collector: researcher Validity of measures used: not reported Outcome relating to child language and cognitive: not reported Outcome relating to child social/emotional measures performance: not reported Outcome relating to child quality of life: not reported Outcome relating to cost: not reported Outcome relating to adverse consequences: Study authors state only, "No adverse events were reported" Number of participants analysed: not reported Data collection measure: not reported Data collector: not reported Validity of measures used: not reported |
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Notes | Funding source: grant from the Israel Heart Fund, and the Carlos Lindenfeld Memorial Fund of the Jewish Community of San Diego, USA | |
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) Physical outcomes | Low risk | Teachers appear to have been involved in intervention design and delivery so we assumed they were not blind to the study allocation. However the outcome is not 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, weight, and skinfold thickness were measured by the same trained individual and were not likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) Physical outcomes | Low risk | Study authors stated that “54 children from the intervention group and 47 children from the control group started the program. No dropouts occurred during the intervention period.” Therefore, risk of attrition bias was considered to be low. |
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 | Low risk | No significant differences in age, gender, body weight and height, BMI, BMI percentiles, body fat, and fitness were found between groups prior to intervention |
Loss of clusters | Low risk | No loss of clusters |
Incorrect analysis | High risk | Classes were randomised, however there was no accounting for clustering of children within classes. |
Contamination | Unclear risk | All 4 preschool classes were from the same community, however there is not enough information provided to assess whether contamination exists. |
Other bias | Unclear risk | No conflict of interest statement was reported. |