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. 2018 May 17;2018(5):CD008552. doi: 10.1002/14651858.CD008552.pub5
Methods Study design:
Randomised controlled trial
Funding:
Not reported
Participants Description:
Children aged 3 to 5 years attending full‐day childcare at the Child Development Laboratory located at The Pennsylvania State University
N (Randomised):
21 children
Age:
Mean = 4.3 years
% Female:
59%
SES and ethnicity:
“most of the families (60%) reported combined family incomes of US>$50,000.”
Inclusion/exclusion criteria:
“Exclusion criteria were the presence of food intolerance to study foods, chronic illness affecting food intake, consuming <22 g of the entree (<10% of the 220‐g entree portion), dislike of the main entree, uncooperative behavior during lunch, non‐English speaking, or extended absences.”
Recruitment:
Not specified
Recruitment rate:
Unknown
Region:
Pennsylvania (USA)
Interventions Number of experimental conditions: 6
Number of participants (analysed):
Overall = 17 (not specified by group)
Description of intervention:
“Children were served a series of 6 lunches in a random order, once per week, which varied only in entrée portion size (entree portion size order: 100, 160, 220, 280, 320, and 400 g). Children were served lunch on the same day of the week at their regularly scheduled time in an eating laboratory dining room facility near their classroom.”
“The menu at all lunches included the portion‐manipulated macaroni and cheese entree and fixed portions of 2% milk and other foods served with the entree (eg, green beans with butter, whole‐wheat roll, and unsweetened applesauce).”
Duration:
6 days
Number of contacts:
6 (1 lunch per day)
Setting:
Preschool
Modality:
Face‐to‐face
Interventionist:
Research staff
Integrity:
No information provided
Date of study:
2007
Description of control:
N/A
Outcomes Outcome relating to children's fruit and vegetable consumption:
Child’s consumption of fruit and vegetable for different entree portion sizes (grams). “Food and milk weights were recorded before and after consumption to the nearest 0.1 g by using digital scales (Mettler‐Toledo PR5001 and Mettler‐Toledo XS4001S; Mettler‐Toledo Inc). The amount of each food item consumed (g) was determined by subtracting postmeal weights from premeal weights.”
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 days
Length of follow‐up post‐intervention:
Immediately
Subgroup analyses:
None
Loss to follow‐up:
Overall = 19% (not specified by group)
Analysis:
Unknown if sample size calculations performed.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomly allocated 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 Low risk Food and milk intake:
Objective measure of child’s food intake and unlikely to be influenced by performance bias
Blinding of outcome assessment (detection bias) All outcomes Low risk Food and milk intake (weighed before and after consumption):
Objective measure of child’s food intake because food was weighed before and after consumption. Low risk of detection bias
Incomplete outcome data (attrition bias) All outcomes Low risk There is no reported attrition. Data are reported for all of the 17 children who met predetermined inclusion criteria
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 are unlikely to be an issue