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临床试验/NCT00756626
NCT00756626已完成不适用

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.

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2008年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Bottle use frequency

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Months 至 13 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

1

Experimental

Intervention group receives bottle weaning intervention from WIC nutritionist

干预措施: Bottle Weaning Intervention (Behavioral)

2

No Intervention

Control standard of care

结局指标

主要结局

Bottle use frequency

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Bonuck

Principal Investigator

Montefiore Medical Center

研究点 (1)

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