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.
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):
- 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.
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
- 否
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
Intervention group receives bottle weaning intervention from WIC nutritionist
干预措施: Bottle Weaning Intervention (Behavioral)
2
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
Karen Bonuck
Principal Investigator
Montefiore Medical Center
