NCT00756626

Brief Summary

This Integrated Project (Research + Extension) aims to reduce the risk of early childhood overweight through changing bottle-feeding behavior. Excess bottles of whole milk and sweet beverages beyond the advised weaning age of 12 months, "inappropriate bottle-feeding," has been linked to overweight. Our pilot of this intervention reduced bottle use. COMPONENTS OF THE 'FEEDING YOUNG CHILDREN STUDY' (FYCS):

  1. 1.Randomized Controlled Trial (RCT)- of a bottle-weaning intervention in low-income multi-ethnic toddlers, will enroll n=464 12 month olds using \>2 bottles/day from two WIC sites. Bottle use, anthropometrics, dietary intake, and nutrient density outcomes will be assessed at Baseline, and 4 times over a 12 month follow-up.
  2. 2.Observational Study- nested within the RCT, will describe dietary intake and nutrient density data (24 hour recalls) for this period of feeding transitions. FYCS fills a gap in knowledge about this population's dietary habits, and their relationship to bottle use.
  3. 3.Extension- our Marketing Department will produce: a 5-8 minute 'infomercial' and nutritionist and client guides (freely downloadable) at WIC, maternal/child health, and pediatric websites, and; a public TV segment. We will disseminate findings through a) the National WIC Association, b) nutrition \& pediatric journals, and; c) lay print, media, and websites with assistance from our Public Relations Department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 4, 2018

Status Verified

May 1, 2018

Enrollment Period

3.2 years

First QC Date

September 19, 2008

Last Update Submit

May 31, 2018

Conditions

Childhood Obesity

Keywords

Bottle WeaningBottle FeedingOverweight in toddlersBottle useexcess weight for length

Outcome Measures

Primary Outcomes (1)

  • Bottle use frequency

    Beverage container assessment done at 12,15,18,21 and 24 months

Secondary Outcomes (2)

  • Anthropometric measurements, age and sex specific weight-for-length.

    Assessed at 12, 15,18, 21 and 24 months

  • Dietary intake and nutrient density

    Assessment at 12 month baseline and 7 to 10 day follow up

Study Arms (2)

1

EXPERIMENTAL

Intervention group receives bottle weaning intervention from WIC nutritionist

Behavioral: Bottle Weaning Intervention

2

NO INTERVENTION

Control standard of care

Interventions

Bottle Weaning InterventionBEHAVIORAL

WIC Nutritionist will deliver bottle weaning intervention education with participants in intervention group at 12 month baseline and at 15, 18, 21, and 24 month follow-up as needed

1

Eligibility Criteria

Age12 Months - 13 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • month olds using 2 bottles a day of non-water liquids.

You may not qualify if:

  • Health or developmental conditions that may affect the child's health or weight.
  • On chronic medications that may affect the child's appetite or growth rate.
  • Medical conditions that may affect the child's appetite or growth rate.
  • Neurological or muscular conditions that affect the child's ability to feed themselves.
  • Steroid treatments such as prednisone that may affect the growth rate of the child.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westchester Square WIC

The Bronx, New York, United States

Location

Related Publications (1)

  • Bonuck K, Avraham SB, Lo Y, Kahn R, Hyden C. Bottle-weaning intervention and toddler overweight. J Pediatr. 2014 Feb;164(2):306-12.e1-2. doi: 10.1016/j.jpeds.2013.09.029. Epub 2013 Oct 31.

    PMID: 24183206DERIVED

MeSH Terms

Conditions

Pediatric ObesityBottle Feeding

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Karen A. Bonuck, PhD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 4, 2018

Record last verified: 2018-05

Locations

US(1)