Assessing Better Bottles for Babies (AB3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Conditional weight gain z-score changes (CWGz)
研究概览
简要总结
This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain.
详细描述
Infants who gain weight rapidly have over 4 times higher odds of developing obesity as a child or adult; infants who are predominantly bottle-fed are at higher risk for excessive infancy weight gain and childhood obesity, yet there are not effective interventions to reduce excessive weight gain among infants who are bottle-fed. The investigators' preliminary work suggest that two novel intervention strategies are feasible and may reduce excessive infancy weight gain: reducing bottle size; and increasing bottle opacity. The investigators aim to test the independent and joint efficacy of these two intervention components among exclusively bottle-fed infants in a randomized, full factorial clinical trial. The investigators' primary objective is to measure the change in conditional weight gain z-score (CWGz) from birth to four months by study group. 4 groups are composed of two conditions: smaller bottles and opaque bottles, independently and in combination, via a 2x2 factorial trial design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is 3 days old to 1 month old
- •Greater than 37 weeks gestational age at birth
- •Birth weight greater than 3% for sex-specific WHO growth standard
- •Caregiver must plan to use local clinic as infant's primary medical home for first 6 months of life
- •Caregiver must speak English or Spanish as primary preferred language
- •Caregiver age 18 years or older
- •Caregiver must agree to use intervention bottles assigned during randomization and agree to stop using their existing bottles during the study period
排除标准
- •Multiple gestation
- •Significant congenital anomaly or acquired or inherited condition directly affecting feeding, physiology, metabolism, or growth
- •Feeding with soy-based, hydrolyzed, lactose-reduced, or elemental formula
- •Weight loss greater than 95% for population reference in the first two weeks of life
研究组 & 干预措施
Small, Clear
This group will receive small-sized clear bottles
干预措施: Clear Bottle (Behavioral)
Standard, Opaque
This group will receive standard-sized opaque bottles
干预措施: Standard Bottle Size (Behavioral)
Standard, Opaque
This group will receive standard-sized opaque bottles
干预措施: Opaque Bottle (Behavioral)
Small, Clear
This group will receive small-sized clear bottles
干预措施: Small Bottle Size (Behavioral)
Small, Opaque
This group will receive small-sized opaque bottles
干预措施: Small Bottle Size (Behavioral)
Standard, Clear
This group will receive standard-sized clear bottles
干预措施: Standard Bottle Size (Behavioral)
Standard, Clear
This group will receive standard-sized clear bottles
干预措施: Clear Bottle (Behavioral)
Small, Opaque
This group will receive small-sized opaque bottles
干预措施: Opaque Bottle (Behavioral)
结局指标
主要结局
Conditional weight gain z-score changes (CWGz)
时间窗: Birth to 4 months
CWGz scores will be calculated for each participant as the residual of the actual weight-for-age z-score at 4 months minus its predicted z-score from linear regression of the 4 month z-score on birth weight z-score. Intent-to-treat analyses will include regression models, stratified by sex, with CWGz score as the outcome.
次要结局
- Formula volume per feed(Birth to 4 months)
- Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS)(Birth to 4 months)