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." |
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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) |
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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 |
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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. |
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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 |