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Sponsors and Collaborators: |
Montefiore Medical Center United States Department of Agriculture |
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Information provided by: | Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT00756626 |
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):
Condition | Intervention | Phase |
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Childhood Obesity |
Behavioral: Bottle Weaning Intervention |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment |
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. |
Estimated Enrollment: | 464 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Intervention group receives bottle weaning intervention from WIC nutritionist
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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
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2: No Intervention
Control standard of care
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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)
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 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.
Ages Eligible for Study: | 12 Months to 13 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karen A. Bonuck, PhD | 718-430-4085 | kbonuck@montefiore.org |
Contact: Christel Hyden, EdD, cand. | 718-430-2753 | christel@chyden.com |
United States, New York | |
Montefiore WIC Program | |
Bronx, New York, United States, 10461 |
Principal Investigator: | Karen A. Bonuck, PhD | Albert Einstein College of Medicine of Yeshiva University |
Responsible Party: | Montefiore Medical Center/ Albert Einstein College of Medicine ( Karen A. Bonuck, PhD ) |
Study ID Numbers: | 03-11-295E, USDA 2007-004556 |
Study First Received: | September 19, 2008 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00756626 History of Changes |
Health Authority: | United States: Federal Government |
Bottle Weaning Bottle Feeding Overweight in toddlers Bottle use excess weight for length |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |