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

Not Applicable

Completed

• Conditions: Educational Intervention and Toddler Bottle Use
• Interventions: Behavioral: Educational Intervention

• Registration Number: NCT02140957
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-16
• Results First Submitted: 2015-11-23
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-06
• Last Update Submitted: 2016-01-06
• Results First Posted: 2016-02-05
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

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

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Educational Intervention	Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
Educational Intervention	Educational Intervention	Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.

Primary Outcome Measures

Name	Time	Method
Change in Iron Depletion	Baseline, 2 years	Iron depletion (serum ferritin \< 10 μg/L).

Secondary Outcome Measures

Name	Time	Method
Current Nighttime Bottle Use	2 years	Current nighttime bottle use.
Current Bottle Use	2 years	Current daytime bottle use.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada