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

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
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
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 environmentChildren
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.
PartnershipsFamilies
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
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
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