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. 2019 Nov 7;2019(11):CD008552. doi: 10.1002/14651858.CD008552.pub6

Kim 2018.

Methods Study design:
Cluster‐randomised controlled trial
Funding:
“there has been no significant financial support for this work that could have influenced its outcome.”
Participants Description:
Children aged 2‐5.5 years with confirmed autism spectrum disorder (ASD) attending applied behaviour analysis (ABA) early intervention agencies for children
N (Randomised):
5 agencies, 35 children
Age:
Child (mean): intervention = 4.4 years, control = 4.0 years
% Female:
Child: intervention = 15%, control = 7%
SES and ethnicity:
Not reported
Inclusion/exclusion criteria:
“inclusion criteria: 1) aged between two and five and a half years, 2) confirmed ASD diagnosis via parental report, 3) reported no extreme food restrictions or medical conditions impeding any kind of food consumption, and 4) received no additional feeding‐related interventions”
Recruitment:
“Participants were recruited via five ABA early intervention agencies for children with ASD located in the metropolitan area of Seoul, Korea.”
Recruitment rate:
Unknown
Region:
Seoul (Korea)
Interventions Number of experimental conditions: 2
Number of participants (analysed):
Intervention = 13, control = 14
Description of intervention:
“The exposure program was administered as one of the ABA curriculum activities. The therapists and assistants (hereafter referred to as ‘staff’) were instructed to conduct a 5–10 min activity designed for a one‐week basis, one activity a day, for four days a week. The one‐week activity set—comprising four different activities—was repeated for four weeks in a month until a new one‐week activity set was started the next month.”
“The final program consisted of 24 play activities, grouped into three levels by the degree of exposure, which was determined based on the time of contact, as well as the size and number of the stimuli. Each activity was repeated four times with three different vegetable and the expected time of contact, as well as the number of vegetables, had increased along with the level process.”
Duration:
6 months
Number of contacts:
96 sessions
Setting:
Early intervention agencies
Modality:
Face‐to‐face
Interventionist:
Therapists and assistants
Integrity:
The first author and an undergraduate research assistant checked treatment fidelity using a 7‐item checklist on a regular basis (twice a week) during agency visits. Interrater agreement for treatment fidelity ranged from 85% to 100%.
Date of study:
Unknown
Description of control:
“In this study, the control group received their usual treatment. The training manual was provided to the control group after the completion of this study.”
Outcomes Outcome relating to children's fruit and vegetable consumption:
Child’s consumption of vegetables (pieces) assessed by staff counting the number of pieces consumed
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:
6 months
Length of follow‐up post‐intervention:
Immediate
Subgroup analyses:
None
Loss to follow‐up (at immediate)
Overall: 23% (8/35)
Analysis:
Unknown if adjusted for clustering
Sample size calculation not performed
“The biggest limitation of this study is the small sample size and the selection of participants using convenient sampling method.”
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Agencies were randomly assigned to either the exposure or control
No further information provided
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Objective measure of child’s vegetable intake and unlikely to be influenced by performance bias
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The experimenter recorded the number of pieces of each food item taken by the child and it is unlikely that this would be influenced by detection bias
Incomplete outcome data (attrition bias) 
 All outcomes High risk Overall loss to follow‐up is: 8/35 (23%), no ITT reported
Selective reporting (reporting bias) Unclear risk Unclear, no protocol, trial registration
Other bias High risk Recruitment bias (low risk): the parents were blind to the group assignment to avoid confounding variables
Baseline imbalance (high risk): from demographic table appears to be no imbalance between groups. However, in table 3 the consumption of vegetable in the exposure group looks significantly higher which trial authors don’t report accounting for
Loss of clusters (low risk): all clusters analysed
Incorrect analysis (low risk): no clustering adjustment reported. The review authors adjusted for in the meta‐analysis
Contamination bias (low risk): agencies at different locations