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N/A N=251 Randomized Double-blind Prevention

Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial

Educational Intervention and Toddler Bottle Use

Enrolled (actual)
251
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Change in Iron Depletion — 88; 83; 12; 17 percentage of participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Educational Intervention (Behavioral)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
The Hospital for Sick Children
Primary completion
Sep 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Iron Depletion
88; 83; 12; 17
SECONDARY
Current Bottle Use
15; 40
SECONDARY
Current Nighttime Bottle Use
3; 10

Summary

Observational studies support an association between bottle feeding beyond 15 to 18 months of age and lower socioeconomic status, excessive milk intake, dental caries, iron deficiency, behavioral issues and obesity. Yet many parents, particularly those from low socioeconomic households, choose to feed their children by bottle much beyond this age. Recognizing the need for further educational interventions for bottle feeding, the TARGet Kids! Research Collaboration recently developed a 5-minute bottle weaning educational intervention for the 9 month well-child visit. We undertook a pragmatic randomized controlled trial to evaluate its effectiveness involving 251 children recruited through TARGet Kids! (PMID: 20624802) The goal was to determine whether an office-based, educational intervention for parents of 9-month-old children could reduce bottle use and iron depletion at 2 years of age.

Eligibility Criteria

Inclusion Criteria

  • Children and their families who participated in The Applied Research Group for Kids (TARGet Kids!) pragmatic RCT

Exclusion Criteria

  • N/A
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02140957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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