Methods |
Study design: Randomised controlled trial Funding: Supported by the Gerber Products company and National Institutes of Health Grant 2RO0HD197S2‐07 |
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Participants |
Description: Mothers and their 4 to 6‐month old infants N (Randomised): 36 children Age: Child (mean): 22 weeks (17‐27 weeks) % Female: 56% SES and ethnicity: Not reported Inclusion/exclusion criteria: “The 36 infants and their mothers who participated met the following criteria: 1. Infants were between 4 and 6 months of age at the beginning of the study; 2. Parents had just begun feeding solid foods and had only given cereals or cereals and fruits; 3. Parents indicated readiness to begin or continue introducing solid foods to the infant; and 4. Absence of medical complications or physical problems.” Recruitment: “Subjects were solicited through birth records and advertisements in local newspapers.” “Parents were contacts and informed of the study before the time their infants would be expected to be introduced to solid foods and contact was reestablished when they were ready to participate.” Recruitment rate: Unknown Region: USA |
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Interventions |
Number of experimental conditions: 4 Number of participants (analysed): Peas salted: 9 Peas unsalted: 10 Green beans salted: 8 Green beans unsalted: 9 Description of intervention: “Foods used throughout the study, pureed peas and green beans, were prepared especially for the study by the Gerber Products Company. Salted and unsalted versions of the two vegetables were prepared. The salted version of each food contained 0.3g NaCI/100g. The foods were presented to the mothers in jars, containing 71g of food and labels did not indicate the presence or absence of salt.” Duration: 10 days Number of contacts: 10 (once per day) Setting: Home Modality: Face‐to‐face Interventionist: Parents Integrity: “On each feeding occasion, parents completed a brief form noting information on the number of the jar used (1through 10), date of feeding, time at the start and end of the feed, infant state of alertness at the beginning of the feed, health of the infant, and the overall quality of the interaction during the feeding.” Date of study: Unknown Description of control: N/A |
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Outcomes |
Outcome relating to children's fruit and
vegetable consumption: Children’s consumption of vegetable (grams): Weighed jars of off before feeding session, resealed and frozen once feeding was finished. Jars collected and weighed by research team to determine grams of intake. Outcome relating to absolute costs/cost‐effectiveness of interventions: Not reported Outcome relating to reported adverse events: No adverse reactions were observed Length of follow‐up from baseline: 25 days Length of follow‐up post‐intervention: Immediately and at 1 week Subgroup analyses: None Loss to follow‐up: There was 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 | “The 36 infants were randomly
assigned to receive either salted or unsalted peas
or green beans; thus forming a total of four
treatment groups.” No mention of how the randomization sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | There is no mention of allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | “The foods were presented to the mothers in jars, containing 71 g of food, and labels did not indicate the presence or absence of salt.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “All ratings were made while mothers and the research assistant were blind to whether infants were fed peas or beans, whether the feedings observed occurred before or after the repeated exposures, and whether or not the infants were being fed salted or unsalted vegetables.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There is no attrition reported. |
Selective reporting (reporting bias) | Unclear risk | There is no trial registration or protocol paper. |
Other bias | Low risk | No other sources of bias were identified. |