Nemet 2011b.
Study characteristics | ||
Methods |
Study design: cluster‐RCT Length of follow‐up from baseline: 1 school year Unit of allocation: kindergarten classes Unit of analysis: child |
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Participants |
Service type: centre‐based (kindergartens) Operation: not reported Country (region): Israel (Central Israel) Country income classification: high Low‐SES sample: yes Population description: low‐SES communities Inclusion criteria: not reported Exclusion criteria: not reported Number of services randomised: 11 (5 intervention, 6 control) Number of children randomised: 342 (154 intervention, 188 control) Characteristics Children Age: Intervention: 5.36 years (SD 0.03) Control: 5.4 years (SD 0.02) Gender (% female): Intervention: 45% Control: 45% 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: 45 children did not complete the study (13.0 %) Reasons for dropout: mainly due to absence in the final data collection day Characteristics of dropouts: not reported |
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Interventions |
Programme name: not reported Number of conditions: 1 intervention, 1 control Intervention duration: 1 school year Intervention setting: ECEC and home Intervention strategies: Health curriculum Children Education: topics such as food groups, vitamins, healthy food choices, food preparation and cooking methods, and information on fast‐food versus home cooking were taught by preschool teachers through short lectures/talks, games, and story reading. Children were encouraged to increase their habitual afterschool physical activity and to reduce sedentary activities. Ethos and environment Children Exposure: children participated in 45‐min/d (3 x 15‐min/d) sessions of exercise training (6 d/week). Once a week, the training was directed by a professional youth coach. During the rest of the week similar physical activity sessions were co‐ordinated by the preschool teacher or assistant. Training took place indoors or outdoors, varied in intensity and duration, was designed primarily as games, and consisted primarily of endurance type activities (e.g. team sports and running). ECEC staff Training: teachers attended an all‐day seminar (lectures and hands‐on sessions) in which they were acquainted with the programme and were trained by the study team so that preschool staff (i.e. teacher and assistant teacher) could perform all the nutritional aspects of the intervention and most exercise classes. 2 additional training days were offered to collect feedback on the programme and to introduce new materials to the teachers. Meeting: summary meeting for teachers at the end the year. Resources: written materials around programme. Preschool teachers also were given a CD collection of children’s songs related to nutrition and exercise. Partnerships Families Events: parents and children were invited to 2 x "Healthy Day Festivals" that focused on healthy nutrition, prevention of child obesity, and beneficial effects of exercise in children. The festivals included lectures given by the study team and games for both children and parents. Resources: monthly flyers detailing nutritional information were sent home via children. Children were asked to present the nutritional information to their parents, and parents were asked to discuss the information with their children. Healthcare Delivery: once a week, the exercise training was directed by a professional youth coach to children. Intensity of intervention: Teachers: 1 x all‐day staff seminar; 2 additional staff training days; 2 x "Health Festival" days (lectures) with parents Intervention delivered by: research team, ECEC staff, healthcare staff Modality: face‐to‐face, written Theoretical basis: not reported Description of control: usual care |
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Outcomes |
Outcomes relating to child dietary intake: not reported Outcomes relating to child physical measures: Weight, BMI, BMI percentile Number of participants analysed: Intervention baseline: 134 Intervention follow‐up: 134 Control baseline: 163 Control follow‐up: 163 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: a grant from the Rosalinde and Arthur Gilbert Foundation and the Israel Heart Fund | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Study authors stated that "Kindergarten classes were randomly assigned by computerized program to participate in a year‐round, in‐school, combined, nutritional and physical activity intervention or to serve as controls (six kindergarten classes in the control group and five the intervention group)." |
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 | 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. However, the outcome is not likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Physical outcomes | Low risk | Study authors stated that "Measurements were performed by an experienced technician who was blinded to the group assignment." |
Incomplete outcome data (attrition bias) Physical outcomes | Low risk | Study authors stated that "Forty‐five children did not complete the study (13.0%) because they were absent at the days of follow‐up measurements (25/188 control and 20/154 intervention) and were therefore excluded from the study." As this is < 20% and numbers are similar across groups and unlikely due to the true outcome, this is unlikely to affect outcomes. Missing data were similar between groups and for similar reasons. 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 | Study authors stated that "Children were included after parental consent" though it is unclear if individual recruitment occurred before or after randomisation of clusters. |
Baseline imbalance | Low risk | Study authors stated that "No significant differences in age, gender, body weight, height, BMI, or BMI percentile were found between groups before the intervention." |
Loss of clusters | Low risk | No clusters appear to have been lost, based on attrition and reasons. |
Incorrect analysis | Low risk | Study authors stated that "When differences between the two groups were identified, a mixed model analysis was performed to ensure no class effect." |
Contamination | Unclear risk | No evidence to make assessment |
Other bias | Unclear risk | No conflict of interest statement was reported |