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

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ClinicalTrials.gov Identifier: NCT02140957
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Jonathon Maguire, 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.

Condition or disease Intervention/treatment Phase
Educational Intervention and Toddler Bottle Use Behavioral: Educational Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial
Study Start Date : January 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Educational Intervention
Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
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.

Placebo Comparator: Control
Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
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.




Primary Outcome Measures :
  1. Change in Iron Depletion [ Time Frame: Baseline, 2 years ]
    Iron depletion (serum ferritin < 10 μg/L).


Secondary Outcome Measures :
  1. Current Bottle Use [ Time Frame: 2 years ]
    Current daytime bottle use.

  2. Current Nighttime Bottle Use [ Time Frame: 2 years ]
    Current nighttime bottle use.



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Ages Eligible for Study:   6 Months to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140957


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Jonathon Maguire, MD The Hospital for Sick Children

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Responsible Party: Jonathon Maguire, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02140957     History of Changes
Other Study ID Numbers: 1000032247
First Posted: May 16, 2014    Key Record Dates
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016
Last Verified: January 2016

Keywords provided by Jonathon Maguire, The Hospital for Sick Children:
Toddler Bottle Use
Educational Intervention
Pediatrics
Iron Deficiency