Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial
January 6, 2016 updated by: Jonathon Maguire, The Hospital for Sick Children
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
251
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children and their families who participated in The Applied Research Group for Kids (TARGet Kids!) pragmatic RCT
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational Intervention
Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
|
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.
|
|
Placebo Comparator: Control
Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Iron Depletion
Time Frame: Baseline, 2 years
|
Iron depletion (serum ferritin < 10 μg/L).
|
Baseline, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Current Bottle Use
Time Frame: 2 years
|
Current daytime bottle use.
|
2 years
|
|
Current Nighttime Bottle Use
Time Frame: 2 years
|
Current nighttime bottle use.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathon Maguire, MD, The Hospital for Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
August 19, 2013
First Submitted That Met QC Criteria
May 15, 2014
First Posted (Estimate)
May 16, 2014
Study Record Updates
Last Update Posted (Estimate)
February 5, 2016
Last Update Submitted That Met QC Criteria
January 6, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 1000032247
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.