This trial is active, not recruiting.

Condition childhood obesity
Treatment bottle weaning intervention
Phase phase 3
Sponsor Montefiore Medical Center
Collaborator USDA Beltsville Human Nutrition Research Center
Start date October 2008
End date June 2011
Trial size 464 participants
Trial identifier NCT00756626, 03-11-295E, USDA 2007-004556


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.


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Intervention group receives bottle weaning intervention from WIC nutritionist
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)
Control standard of care

Primary Outcomes

Bottle use frequency
time frame: Beverage container assessment done at 12,15,18,21 and 24 months

Secondary Outcomes

Anthropometric measurements, age and sex specific weight-for-length.
time frame: Assessed at 12, 15,18, 21 and 24 months
Dietary intake and nutrient density
time frame: Assessment at 12 month baseline and 7 to 10 day follow up

Eligibility Criteria

Male or female participants from 12 months up to 13 months old.

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.

Additional Information

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.
Principal investigator Karen A. Bonuck, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Montefiore Medical Center.