CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 251 enrolled
Drug / intervention
Educational Interventionbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02140957
NCT02140957N/ACompleted

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

The Hospital for Sick Children·interventional·Posted May 16, 2014·Updated Feb 5, 2016

In Brief

A clinical study evaluating Educational Intervention for Educational Intervention and Toddler Bottle Use. Completed, enrolled 251 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 16, 2014
Enrollment StartJan 1, 2007
Primary CompletionSep 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.1 years ago

Interventions

Educational Interventionbehavioral

Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information.