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

T

The Hospital for Sick Children

Status

Completed

Conditions

Educational Intervention and Toddler Bottle Use

Treatments

Behavioral: Educational Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02140957
1000032247

Details and patient eligibility

About

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.

Enrollment

251 patients

Sex

All

Ages

6 months to 1 year old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • N/A

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

251 participants in 2 patient groups, including a placebo group

Educational Intervention
Experimental group
Description:
Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.
Treatment:
Behavioral: Educational Intervention
Control
Placebo Comparator group
Description:
Parents in this arm received a placebo which consisted of standard nutritional counseling alone.
Treatment:
Behavioral: Educational Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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