Nemet 2011a.
Study characteristics | ||
Methods |
Study design: cluster‐RCT Length of follow‐up from baseline: 12 months Unit of allocation: kindergarten class Unit of analysis: child |
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Participants |
Service type: kindergartens (within schools) Operation: not reported Country (region): Israel (Sharon) Country income classification: high Low‐SES sample: yes Population description: low‐SES communities in the Sharon area, Israel. SES was determined with criteria set by the Israeli Central Bureau of Statistics. A scale of 1‐10 refers to the SES, whereas low SES was defined by a score of 1‐4. The score is comprised of the level of education, employment/unemployment status, income level, number of children per family, number of people per household, and additional standard of living characteristics (e.g. brand and model of cars) Inclusion criteria: kindergartens from low‐SES communities in the Sharon area, Israel. Low‐SES classification refers to 1‐4 on 10‐point scale with criteria set by the Israeli Central Bureau of Statistics. Exclusion criteria: not reported Number of services randomised: 30 classes (15 intervention, 15 control) Number of children randomised: 725 (376 intervention, 349 control) Characteristics Children Age: Intervention: 5.2 years (SD 0.02) Control: 5.24 years (SD 0.03) Gender (% female): Intervention: 46% Control: 44% 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: 70 children did not complete the study (8.8%) (29/378 control, 41/417 intervention) Reasons for dropout: children absent on the days of follow‐up measurements Characteristics of dropouts: not reported |
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Interventions |
Programme name: not reported Number of conditions: 1 intervention, 1 control Intervention duration: 1 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 (divided to 3 x 15‐min sessions/d) 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 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. Activities: children were asked to present the flyer on 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: 2 x staff training days; 2 x healthy day festivals with parents; nutrition activities delivered to children (frequency and duration not reported); monthly nutrition flyers sent home for children and parents to discuss; 3 x 15‐min physical activity sessions/week for children; 1 x CD with song on nutrition and physical activity 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: 376 Intervention follow‐up: 376 Control baseline: 349 Control follow‐up: 349 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: 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 | Kindergarten classes were randomly assigned by computerised program to intervention or control 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 | Children's height and weight were measured by an experienced technician who was blinded to group assignment. |
Incomplete outcome data (attrition bias) Physical outcomes | Low risk | Study authors stated that "Seventy children did not complete the study (8.8%), because they were absent on the days of follow‐up measurements (29/378 control, 41/417 intervention) and therefore were excluded from the study. Seven hundred twenty‐five participants completed the study (349 control subjects, 376 subjects treated with intervention)." 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 | It is unclear whether individuals were recruited to the study before or after randomisation of clusters. |
Baseline imbalance | Low risk | Baseline characteristics of age, sex, and weight status were reported, although no statistical test of difference is reported. |
Loss of clusters | Unclear risk | Not reported |
Incorrect analysis | Low risk | Study authors stated that "A two‐way repeated measures analysis of variance was used to compare effects of the intervention on body weight, height, BMI, BMI percentiles, nutrition and physical activity knowledge and preferences and fitness between the intervention participants and the control participants with time serving as the within group, and intervention as the between group factor. When differences between the 2 groups were identified, a mixed model analysis was performed, to ensure no class effect." |
Contamination | Unclear risk | No evidence to make assessment |
Other bias | Low risk | No clear other source of bias |