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. 2018 May 17;2018(5):CD008552. doi: 10.1002/14651858.CD008552.pub5
Methods Study design:
Randomised controlled trial – cross‐over
Funding:
"European Community’s Seventh Framework Programme (FP7/2007‐2013) under the Grant agreement No. 245012‐HabEat."
Participants Description:
Preschool‐aged children recruited from 3 daycare centres in Wageningen, the Netherland
N (Randomised):
40 children
Age:
21 to 46 months (mean = 36 months)
% Female:
50%
SES and ethnicity:
Not specified
Inclusion/exclusion criteria:
Inclusion criteria: “Inclusion into the study required presence of the child at the day care‐centre for at least 2 days per week.”
Exclusion criteria. “Participants were screened for food allergies and health problems (as reported by the parents)”
Recruitment:
“A total of 40 healthy children aged 2–4 years were recruited from 2 day care‐centres in Wageningen, The Netherlands. Participation was voluntary and parents and day care‐centres were thoroughly informed about the study. Written parental consent was given for the participating children.”
Recruitment rate:
Unknown
Region:
Wageningen (The Netherlands)
Interventions Number of experimental conditions: 2
Number of participants (analysed):
Spinach high‐energy/endive low‐energy = 15
Endive high‐energy/spinach low‐energy = 13
Description of intervention:
“During the intervention period, half of the participants (n = 20) received vegetable soup flavour A low in energy content (LE) consistently paired with vegetable soup flavour B high in energy content (HE), whereas the other half of the participants received the reverse (i.e. flavour A HE + flavour B LE).”
Duration:
7 weeks
Number of contacts:
14 exposures (twice/week)
Setting:
Preschool
Modality:
Face‐to‐face
Interventionist:
Daycare leaders
Integrity:
No information provided
Date of study:
Unknown
Description of control:
N/A
Outcomes Outcome relating to children's fruit and vegetable consumption:
As‐desired consumption of vegetable soup (grams). “Consumption was measured by pre‐ and post‐weighing on a digital scale with a precision of 0.1 g.”
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:
8 weeks and 4 and 8 months
Length of follow‐up post‐intervention:
1 week and at 2 and 6 months
Subgroup analyses:
None
Loss to follow‐up (at 2 and 6 months):
Overall: 32%, 39% (not specified by group)
Analysis:
Sample size calculation was performed.
Notes
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 Low risk Vegetable intake (objective):
The children and the daycare leaders were blinded to the treatment, i.e. they were unaware which product was high or low in energy and therefore low risk of performance bias
Blinding of outcome assessment (detection bias) All outcomes Low risk Vegetable intake (objective):
Outcome was pre‐post weight of soup bowl assessed by researcher. Researchers were not blinded to group allocation (as they served the soup (2 x green soups varying in energy intake)) and researcher was not present in room during consumption of soup
Incomplete outcome data (attrition bias) All outcomes High risk Of 40 eligible children, 12 were excluded from data analysis due to low intake levels during the conditioning period. Of 28 children 17 (61%) completed the 6‐month follow‐up
Selective reporting (reporting bias) Low risk The primary outcomes reported in the paper align with those specified in the trial registration
Other bias Low risk Contamination, baseline imbalance, & other bias that could threaten the internal validity are unlikely to be an issue