Feeding Young Children Study: Bottle Weaning Intervention (FYCS)
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bottle Weaning Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Bottle Weaning, Bottle Feeding, Overweight in toddlers, Bottle use, excess weight for length
Eligibility 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.
Sites / Locations
- Westchester Square WIC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Intervention group receives bottle weaning intervention from WIC nutritionist
Control standard of care
Outcomes
Primary Outcome Measures
Bottle use frequency
Secondary Outcome Measures
Anthropometric measurements, age and sex specific weight-for-length.
Dietary intake and nutrient density
Full Information
NCT ID
NCT00756626
First Posted
September 19, 2008
Last Updated
May 31, 2018
Sponsor
Montefiore Medical Center
Collaborators
United States Department of Agriculture (USDA)
1. Study Identification
Unique Protocol Identification Number
NCT00756626
Brief Title
Feeding Young Children Study: Bottle Weaning Intervention
Acronym
FYCS
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
United States Department of Agriculture (USDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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):
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.
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.
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.
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)
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.
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)
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Bottle Weaning, Bottle Feeding, Overweight in toddlers, Bottle use, excess weight for length
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Intervention group receives bottle weaning intervention from WIC nutritionist
Arm Title
2
Arm Type
No Intervention
Arm Description
Control standard of care
Intervention Type
Behavioral
Intervention Name(s)
Bottle Weaning Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Bottle use frequency
Time Frame
Beverage container assessment done at 12,15,18,21 and 24 months
Secondary Outcome Measure Information:
Title
Anthropometric measurements, age and sex specific weight-for-length.
Time Frame
Assessed at 12, 15,18, 21 and 24 months
Title
Dietary intake and nutrient density
Time Frame
Assessment at 12 month baseline and 7 to 10 day follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
13 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen A. Bonuck, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westchester Square WIC
City
Bronx
State/Province
New York
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24183206
Citation
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.
Results Reference
derived
Learn more about this trial
Feeding Young Children Study: Bottle Weaning Intervention
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