Methods |
Study design: Randomised controlled trial Funding: “Funding for this research was provided by an unrestricted grant from ‘‘Get Kids in Action,’’ a partnership between the Gatorade Corporation and the University of North Carolina.” |
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Participants |
Description: Children aged 2 to 5 years and their parent N (Randomised): 50 parent‐child dyads Age: Child (mean): Intervention = 3.9 years, Control = 3.3 years Parent (mean): Intervention = 36.6 years, Control = 36.2 years % Female: Child: Intervention = 59%, Control = 67% Parent: Intervention = 86%, Control 90% SES and ethnicity: Parent (non‐white): Intervention = 18%, Control = 10% Income (USD): < 50,000: Intervention = 18%, Control = 81% ≥ 50,000: Intervention = 77%, Control = 19% Education: College or less: Intervention = 36%, Control = 43% Inclusion/exclusion criteria: At least 1 child 2 ‐ 5 years old, “Additional eligibility criteria included having lived in their current residence and planning to stay in that residence for at least 6 months. If the family had more than 1 eligible child, the eldest was selected as the reference child” Recruitment: “A convenience sample of 50 parent‐child dyads, with at least 1 child 2‐5 years old, was recruited through child care centers, listservs, and community postings. Interested parents responded to recruitment materials and were screened by phone.” Recruitment rate: Unknown Region: USA |
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Interventions |
Number of experimental conditions: 2 Number of participants (analysed): Intervention = 22, control = 21 Description of intervention: “addressed vegetable and food issues based on the baseline surveys, and the dietitian helped parents select 1 primary target area for improvement during the intervention from 4 possible options (vegetable availability; picky eating; modeling; family meals). These areas were selected based on Social Cognitive Theory, which posits that there is reciprocal interaction between an individual and his/her environment. This theory also highlights the importance of self‐efficacy, which was thus a target of the intervention as well.” Duration: 4 months Number of contacts: 6 (2 phone calls, 4 newsletters) Setting: Home Modality: Multiple (telephone, newsletters) Interventionist: A registered dietitian Integrity: No information provided Date of study: April and December 2009 Description of control: “Control group families received 4 non‐health/nutrition related children's books, 1 per month.” |
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Outcomes |
Outcome relating to children's fruit and
vegetable consumption: Child’s consumption of vegetables (servings per day) assessed using a Block Kids food frequency questionnaire (FFQ) completed by parents. 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: 5 months Length of follow‐up post‐intervention: Immediate Subgroup analyses: None Loss to follow‐up: Intervention = 12% Control = 16% Analysis: Unknown if sample size calculations performed |
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Notes | To enable inclusion in meta‐analysis, we
calculated post‐intervention means by group
by summing baseline and change from baseline means,
and assumed baseline SDs for
post‐intervention SDs. Sensitivity analysis ‐ primary outcome: Primary outcome not stated, fruit or vegetable intake 2nd listed outcome after height and weight |
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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 | High risk | Child vegetable intake (parent reported): There is no blinding to group allocation of participants or personnel described and this is likely to influence performance |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Child vegetable intake (parent reported): There is no blinding to group allocation of participants or personnel described and because this is a parent‐reported measure at high risk of detection bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 43 (86%) of the 50 parent‐child dyads recruited completed the study. Therefore at low 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 | Unclear risk | Participants differed on child age by condition. However although this was adjusted for in the analysis the impact of this imbalance is unclear |