Feeding Young Children Study: Bottle Weaning Intervention (FYCS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Montefiore Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00756626
First received: September 19, 2008
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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. 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. 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. 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.

Condition Intervention Phase
Childhood Obesity
Behavioral: Bottle Weaning Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Feeding Young Children Study (FYCS)- a Randomized Control Trial of a Bottle Weaning Intervention Aimed at Reducing the Risk of Overweight in Low Income Multi-ethnic Toddlers.

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Bottle use frequency [ Time Frame: Beverage container assessment done at 12,15,18,21 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anthropometric measurements, age and sex specific weight-for-length. [ Time Frame: Assessed at 12, 15,18, 21 and 24 months ] [ Designated as safety issue: No ]
  • Dietary intake and nutrient density [ Time Frame: Assessment at 12 month baseline and 7 to 10 day follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 464
Study Start Date: October 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intervention group receives bottle weaning intervention from WIC nutritionist
Behavioral: Bottle Weaning Intervention
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
No Intervention: 2
Control standard of care

Detailed Description:

Mounting evidence finds that obesity tracks with age, even from infancy.1-10 Excess bottles of whole milk and sweet beverages beyond the advised weaning age of 12 months- inappropriate bottle-feeding- is linked to overweight. Inappropriate bottle use as used herein refers to children > 12 months drinking > 2 bottle-type containers/day. In our prior work inappropriate bottle use was associated with overweight in local WIC centers and national survey data. And,a February 2007 publication from a national study found that "taking a bottle to bed" was a major predictor of 3 year olds' being overweight or obese. Our pilot of the proposed intervention reduced daily bottle use.

The Feeding Young Children Study (FYCS) is a randomized controlled trial (RCT) of a bottle-weaning intervention aimed at reducing the risk of overweight in low-income multi-ethnic toddlers in WIC.

Aim #1: To reduce inappropriate bottle-feeding practices (RCT)

1.The Intervention group will reduce inappropriate feeding practices, as measured by: absolute weaning; # of bottles; ounces consumed from bottles; and content, pattern & timing of bottles.

Aim#2: To decrease the risk of overweight in children (RCT)

  1. The Intervention group will see a decrease in the percentage of children >85th percentile weight-for-length, and > 95th % ile weight-for-length over the 12 month follow-up.
  2. The Intervention group will have lower age- and sex-adjusted weight-for-length z scores; and a decreased weight gain velocity over the 12 month follow-up, compared with Controls.

Aim #3: To understand dietary intake & nutrient density (Observational Study)

1. We will describe beverage and food intakes and nutrient density at baseline and over time in relation to bottle use patterns and anthropometrics, for the sample and by treatment group.

Aim #4: To produce sustainable products and widely disseminate findings (Extension)

  1. We will produce a 5-8 minute bottle-weaning infomercial, and nutritionist and client guides for download from WIC,15 maternal/child health16,17 and pediatric18 websites-- as well as a segment for "Keeping Kids Healthy," a nationally syndicated, Emmy award winning TV show.
  2. We will extend findings through a) lay print, media, and web outlets via Public Relations; b) the National WIC association; and c) nutrition & pediatric journal papers.

We will enroll n=464 12 month olds who are drinking >2 (non-water) bottles or sippy cups/day, from 2 Bronx WIC sites. Bottle/sippy cup use, anthropometrics, and dietary intake will be assessed at Baseline, and again at 15, 18, 21, and 24 months of age. FYCS nutritionists (blinded to group assignment) will collect two 24 h recalls of all beverage and solid intake, and enter it into the Windows-based Nutrition Data Systems for Research software, the premiere dietary data collection and nutrient density calculation tool. WIC nutritionists will administer the Intervention at Baseline, and (blinded to outcomes) as needed at follow-ups.

  Eligibility

Ages Eligible for Study:   12 Months to 13 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756626

Locations
United States, New York
Westchester Square WIC
Bronx, New York, United States
Sponsors and Collaborators
Montefiore Medical Center
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: Karen A. Bonuck, PhD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided by Montefiore Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen A. Bonuck, PhD, Montefiore Medical Center/ Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00756626     History of Changes
Other Study ID Numbers: 03-11-295E, USDA 2007-004556
Study First Received: September 19, 2008
Last Updated: October 1, 2010
Health Authority: United States: Federal Government

Keywords provided by Montefiore Medical Center:
Bottle Weaning
Bottle Feeding
Overweight in toddlers
Bottle use
excess weight for length

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 18, 2014