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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

Tracking Information
First Submitted Date  ICMJE August 19, 2013
First Posted Date  ICMJE May 16, 2014
Results First Submitted Date  ICMJE November 23, 2015
Results First Posted Date  ICMJE February 5, 2016
Last Update Posted Date February 5, 2016
Study Start Date  ICMJE January 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
Change in Iron Depletion [ Time Frame: Baseline, 2 years ]
Iron depletion (serum ferritin < 10 μg/L).
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
Change in Oral Health Status [ Time Frame: Baseline, +5 years ]
The primary outcome is the between-group (intervention vs. placebo) difference in oral health status defined as total number of decayed, missing due to decay, or filled teeth (DMFT).
Change History Complete list of historical versions of study NCT02140957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • Current Bottle Use [ Time Frame: 2 years ]
    Current daytime bottle use.
  • Current Nighttime Bottle Use [ Time Frame: 2 years ]
    Current nighttime bottle use.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • Change in Quality of Life [ Time Frame: Baseline, +5 years ]
    Oral health related quality of life.
  • Change in Iron Stores [ Time Frame: Baseline, +5 years ]
    Iron stores as measured by serum ferritin.
  • Change in Iron Depletion [ Time Frame: Baseline, +5 years ]
    Iron depletion (serum ferritin < 10 μg/L).
  • Change in Anemic status [ Time Frame: Baseline, +5 years ]
    Iron deficiency anemia (ferritin < 10 μg/L and hemoglobin < 11 g/dL).
  • Current Bottle Use [ Time Frame: +5 years ]
    Current daytime and nighttime bottle use.
  • Current Milk Intake [ Time Frame: +5 years ]
    Daily cow's milk intake.
  • Change in Obesity Status [ Time Frame: Baseline, +5 years ]
    Measured through BMI (kg/m2).
  • Change in Child Behavior [ Time Frame: Baseline, +5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial
Official Title  ICMJE Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Educational Intervention and Toddler Bottle Use
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Educational Intervention
    Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
    Intervention: Behavioral: Educational Intervention
  • Placebo Comparator: Control
    Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
    Intervention: Behavioral: Educational Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2014)
251
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02140957
Other Study ID Numbers  ICMJE 1000032247
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathon Maguire, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathon Maguire, MD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP