Methods |
Study design: Randomised controlled trial Funding: “Supported by grants HD37119 and HD08428 from the National Institutes of Health and by a grant from the Gerber Companies Foundation. The Gerber Products Company supplied the baby foods used in this study.” |
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Participants |
Description: Mothers with healthy, term infants N (Randomised): 48 mother‐infant dyads Age: Infant (mean): carrot group = 4.6 months, potato group = 4.5 months, variety group = 4.8 months Mother (mean): carrot group = 27.4 years, potato group = 25.4 years, variety group = 29.9 years % Female: Infant: carrot group = 50%, potato group = 50%, variety group = 50% SES and ethnicity: “The racial background of the mothers and their infants was 45.8% African American, 39.6% white, 2.1% Hispanic, and 12.5% other ethnic groups.” Inclusion/exclusion criteria: Inclusion criteria: non‐smoking mothers, began feeding cereal to their infants in the past month and planned on introducing other solid foods during the next few weeks, and only mothers of formula‐fed infants. Recruitment: “recruited from advertisements in local newspapers and from Women, Infant and Children programs in Philadelphia.” Recruitment rate: Unknown Region: Philadelphia, USA |
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Interventions |
Number of experimental conditions: 3 Number of participants (analysed): Carrot group: 16 Potato group: 16 Variety group: 16 Description of intervention: Carrot group: during the home exposure period infants were fed pureed carrots only (the target vegetable). Potato group: during the home exposure period infants were fed pureed potatoes only. Variety group: during the home exposure period infants were fed a variety of vegetables that did not include carrots (potato, squash, peas). All groups were fed pureed carrots in the lab on days 1 and 11. Duration: 11 days Number of contacts: 11 exposures (9 day home exposure + 2 lab exposures/test days) Setting: Home + lab Modality: Face‐to‐face Interventionist: Mothers Integrity: “To encourage compliance, each mother kept a daily record of what they fed their infants, and daily phone contact was made with each mother during the exposure period.” Date of study: Unknown Description of control: N/A |
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Outcomes |
Outcome relating to children's fruit and
vegetable consumption: Consumption of pureed carrots (grams): assessed by weighing the amount of the food in the jar before and after consumption using a top‐loading balance. 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: 11 days Length of follow‐up post‐intervention: Immediately Subgroup analyses: None Loss to follow‐up: No loss to follow‐up 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 assigned to one of 3
experimental groups” not
enough information reported. Randomly allocated to experimental group but the random sequence generation procedure is not described. |
Allocation concealment (selection bias) | Unclear risk | No information reported 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 | High risk | Mothers fed their infants and there is no mention of blinding and so high risk of performance bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Vegetable intake was determined by weighing vegetables and therefore low risk of detection bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up – 16 dyads per
group All participants recruited completed the study and therefore at low risk of attrition bias |
Selective reporting (reporting bias) | Unclear risk | No trial protocol is available |
Other bias | Low risk | Low risk of other bias |