Methods |
Study design: Randomised controlled trial Funding: Not reported |
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Participants |
Description: Children aged 4 to 9 months and their mother N (Randomised): 88 parent‐children dyads Age: Child (mean): Study 1 fruits = 6.7 months, Study 2 vegetables = 6.3 months Mother (mean): Study 1 fruits = 29 years, Study 2 vegetables = 28 years % Female: Child: Study 1 fruits = 49%, Study 2 vegetables = 43% Parent: 100% SES and ethnicity: Parent: “Their ethnic background was 55.4% (N =41) Black; 29.7% (N =22) White; 2.7% (N =2) Hispanic and 12.2% (N =9) Other/Mixed Ethnicity.” SES not specified Inclusion/exclusion criteria: “To qualify the Children had to have at least two weeks of experience eating cereal or fruit from a spoon and little experience with the target fruits and vegetables.” Recruitment: “Seventy‐four mothers whose Children were between the ages of 4 and 9 months were recruited from advertisements in local newspapers and from Women, Children and Children Programs in Philadelphia, PA.” Recruitment rate: Not specified Region: Philadelphia (USA) |
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Interventions |
Number of experimental conditions: 5 Number of participants (analysed): Study 1: fruits Pear group = 20 dyads, between‐meal (BM) group = 19 dyads Study 2: vegetables Green bean group = 11 dyads, between‐meal (BM) group = 12 dyads, between‐meal and within‐meal (BM‐WM) group = 12 dyads Description of intervention: Study 1: fruits “During the home exposure period, one group fed only pears at the target meal (Pear Group, N=20) whereas the other group fed a fruit which was different than the one experienced during the previous 2 days (Between‐Meal (BM) Fruit Variety Group, N=19).” Study 2: vegetables “The three groups differed in the type, amount and variety of foods that infants were fed during the target meal during the 8‐day home exposure period. The infants in the Green Bean Group (N=11) were fed only the target vegetable, green beans, whereas those in the Between‐Meal variety group (BM Vegetable Variety Group, N=12) and the Between‐Meal and Within‐Meal Variety Group (BM–WM Vegetable Variety Group, N=12) were fed a variety of vegetables. The BM Variety Group was fed only one vegetable each day and green and orange vegetables were alternated daily, whereas the BM–WM Variety Group was fed two vegetables each day (one green, one orange). In the latter group, the pair of vegetables varied from day‐to‐day but one of the pair was experienced the prior day.” Duration: 8 days Number of contacts: 8 exposures Setting: Home Modality: Face‐to‐face Interventionist: Mothers Integrity: “All of the mothers complied with these instructions.” Date of study: Unknown Description of control: N/A |
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Outcomes |
Outcome relating to children's fruit and
vegetable consumption: Child’s consumption of fruit and vegetable purees (grams). Mother resealed jars and returned them after the exposure period to be weighed 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: 12 days (4 days of test food(s)) Length of follow‐up post‐intervention: 2 days Subgroup analyses: None Loss to follow‐up: Condition 1: fruits Overall = 15% (no specified by group) Condition 2: vegetables Overall = 17% (no specified by group) Analysis: Unknown if 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 | Unclear risk | Fruit & vegetable intake: The mother fed the child and there is no mention of blinding, therefore at unclear risk of performance bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The mother fed the child and there is no mention of blinding. However, this is an objective measure of intake, and therefore low risk of detection bias |
Incomplete outcome data (attrition bias) All outcomes | High risk | Mother‐infant pairs were excluded from the study because they did not comply with experimental procedures or ate less than 5 grams on the testing days. An intention‐to‐treat approach was not adopted and therefore at high risk of attrition bias |
Selective reporting (reporting bias) | Unclear risk | There is no study protocol therefore it is unclear if there was selective outcome reporting |
Other bias | High risk | The groups differed significantly in the fruit study (Study 1) in terms of approachability and there is no mention that this difference was adjusted for in the analysis |