Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial
1 other identifier
interventional
251
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 19, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedResults Posted
Study results publicly available
February 5, 2016
CompletedFebruary 5, 2016
January 1, 2016
2.7 years
August 19, 2013
November 23, 2015
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Iron Depletion
Iron depletion (serum ferritin \< 10 μg/L).
Baseline, 2 years
Secondary Outcomes (2)
Current Bottle Use
2 years
Current Nighttime Bottle Use
2 years
Study Arms (2)
Educational Intervention
EXPERIMENTALParents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
Control
PLACEBO COMPARATORParents in this arm received a placebo which consisted of standard nutritional counseling alone.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Children and their families who participated in The Applied Research Group for Kids (TARGet Kids!) pragmatic RCT
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jonathon Maguire
- Organization
- St. Michael's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathon Maguire, MD
The Hospital for Sick Children
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
August 19, 2013
First Posted
May 16, 2014
Study Start
January 1, 2007
Primary Completion
September 1, 2009
Study Completion
October 1, 2009
Last Updated
February 5, 2016
Results First Posted
February 5, 2016
Record last verified: 2016-01