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. 2020 May 25;2020(5):CD008552. doi: 10.1002/14651858.CD008552.pub7

Baskale 2011.

Study characteristics
Methods Study design
C‐RCT
Funding
“No external or intramural funding was received.”
Participants Description
Children 5 years of age in 12 nursery schools connected to the Izmir Provincial Directorate of National Education
N (randomised)
6 preschools, 238 children
Age
Child: 5 years of age
Parent (mean): intervention mothers = 33.4 years, control mothers = 33.4 years, intervention fathers = 36.9 years, control fathers = 36.8 years
% female
Child: intervention = 60%, control = 48%
Parent: not reported
SES and ethnicity
Family SES: low = 16%, medium = 73%, upper = 11%
Parent: education levels reported.
Mother: primary = 9%, secondary school = 15%, high school = 38%, university = 38%.
Father: primary = 10%, secondary school = 14%, high school = 37%, university = 40%
Inclusion/exclusion criteria
Not reported
Recruitment
Not reported
Recruitment rate
Child: not reported
Nursery: not reported
Region
Izmir (Turkey)
Interventions Number of experimental conditions
2
Number of participants (analysed)
Intervention = 141, control = 97
Description of intervention
“The content of the education guided by Piaget’s theory included play and visual materials. Thus, healthy food choices were created by means of play/games. Following age‐appropriate education carried out using Piaget’s theory, improvements are observed in food selection and consumption”
Duration
Initial intervention = 6 weeks and at 1 year follow‐up a 3 week refresher intervention (20 to 30 minutes per session)
Number of contacts
9 sessions (1 per week)
Setting
Preschool
Modality
Face‐to‐face
Interventionist
“The researcher (H.B.), who is a nurse educator, was the interventionist for all sessions.”
Integrity
No information provided
Date of study
February 2007 to June 2008
Description of control
“The children in the control group had not received nutrition education but they had received a general program of education (the nutrition education prescribed by the Ministry of National Education preschool). The yearly syllabus of the Ministry includes subjects on nutrition every 2 months. This time frame, however, may be insufficient for nutrition education.”
Outcomes Outcome relating to children's fruit and vegetable consumption
Child’s consumption of fruits and vegetables assessed using food frequency questionnaire (FFQ) completed by parents
Outcome relating to absolute costs/cost effectiveness of interventions
Not reported
Outcome relating to reported adverse events
Not reported
Length of follow‐up from baseline
Post‐test: 4 months (pre‐test February 2007 – post‐test June 2007)
Post‐test 2: 16 months (post‐test 2 June 2008)
Length of follow‐up postintervention
Post‐test: 2 months
Post‐test 2: 14 months
Subgroup analyses
None
Loss to follow‐up (at 2 and 14 months)
Intervention: 1%, 52%
Control: 9%, 51%
Analysis
Did not adjust for clustering
Sample size calculation was performed.
Notes Sensitivity analysis ‐ primary outcome: Primary outcome not stated, power calculation conducted on knowledge only
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomly allocated to experimental group but the random sequence generation procedure is not described
Allocation concealment (selection bias) Unclear risk There is no information provided about allocation concealment and therefore it is unclear if allocation was concealed
Blinding of participants and personnel (performance bias)
All outcomes High risk Nutrition knowledge & food frequency (self‐reported)
There is no blinding to group allocation of participants or personnel described and this is likely to influence performance
Blinding of outcome assessment (detection bias)
All outcomes High risk Nutrition knowledge & food frequency
There is no mention that participants were blinded to group allocation and therefore the risk of detection bias is high
Incomplete outcome data (attrition bias)
All outcomes High risk 67/141 (48%) in experimental group and 48/97 (49%) in control group completed post‐test 2 and therefore risk of attrition bias is high
Selective reporting (reporting bias) Unclear risk There is no study protocol therefore it is unclear if there was selective outcome reporting
Other bias Low risk Contamination, baseline imbalance, & other bias that could threaten the internal validity do not appear to be an issue