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临床试验/NCT02893319
NCT02893319已完成不适用

Role of Infant Feeding, Childhood Food Habits and Early Childhood Adiposity (RIF)

Leann Birch0 个研究点目标入组 115 人开始时间: 2014年6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
发起方
入组人数
115
主要终点
Change in Infant Weight-for-Age Z-score over time by group

研究概览

简要总结

Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with early rapid growth, and include high maternal BMI prior to pregnancy and excessive gestational weight gain. This research focuses on aspects of early feeding as potentially modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads are also included. The hypothesis is that differences in feeding practices will be associated with differences in growth and that infants randomized to be fed from smaller bottles will grow more slowly that those randomized to larger bottles. Growth patterns of formula fed infants will also be compared to those of exclusively breastfed infants.

详细描述

Mothers complete feeding logs, questionnaires on health history, demographics, feeding attitudes and practices. Infant growth and body composition are measured via PEA POD, and maternal anthropometrics and body composition are measured in BOD POD the laboratory at 2, 8, and 16 weeks postpartum. Primary outcome is change in weight-for-age z-scores.

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 (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant or newborn aged 28 days or younger

排除标准

  • gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight

研究组 & 干预措施

Breastfeeding

No Intervention

control group

5 oz bottle

Active Comparator

Subject will feed infant with 5oz medela bottle

干预措施: Feeding and growth differences, 5oz vs 8oz bottle (Behavioral)

8 oz bottle

Active Comparator

Subject will feed infant with 8oz medela bottle

干预措施: Feeding and growth differences, 5oz vs 8oz bottle (Behavioral)

结局指标

主要结局

Change in Infant Weight-for-Age Z-score over time by group

时间窗: 2, 8 and 16 weeks of age

Infant weight (kg) (PEA POD scale) will be measured at each of three time points (2, 8, 16 weeks of age). Weight-for-Age Z-score (WAZ) will be calculated based on World Health Organization Global Database on Child Growth, means will be calculated and compared.

次要结局

未报告次要终点

研究者

发起方
Leann Birch
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leann Birch

William P. Flatt Professor

University of Georgia

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