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

Educational Intervention and Toddler Bottle Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140957
• Other study ID #: 1000032247
• Status: Completed
• Phase: N/A
• First received: August 19, 2013
• Last updated: January 6, 2016
• Start date: January 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 1 Year

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Educational Intervention and Toddler Bottle Use

Intervention

Behavioral:
• Educational Intervention
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Iron Depletion	Iron depletion (serum ferritin < 10 µg/L).	Baseline, 2 years	No
Secondary	Current Bottle Use	Current daytime bottle use.	2 years	No
Secondary	Current Nighttime Bottle Use	Current nighttime bottle use.	2 years	No