Does Paced Bottle-Feeding Improve the Quality and Outcome of Bottle-Feeding Interactions?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Infant Milk Intake between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
研究概览
简要总结
Current infant feeding recommendations focus on promoting responsive feeding, which is widely recognized as the ideal way to feed infants because it is associated with healthier eating behaviors and growth outcomes for infants. Unfortunately, many bottle-feeding families receive inadequate support for learning responsive bottle-feeding practices because breastfeeding support is prioritized in healthcare settings. Promotion of breastfeeding is an important focus for public health efforts, but a significant proportion of families bottle-feed their infants, either exclusively or in combination with breastfeeding. Thus, bottle-feeding remains a ubiquitous part of infant feeding and evidence-based strategies are needed to support bottle-feeding families. One promising strategy is the Paced Bottle-Feeding (PBF) method, which incorporates many ideas and feeding practices consistent with the concept of responsive feeding. This approach to bottle-feeding aims to mimic the aspects of breastfeeding that promote balanced control between caregiver and infant and allow the infant to set the pace of the feeding in response to feelings of hunger and fullness. Although PBF is sometimes taught in perinatal education settings, teaching new parents about PBF is not an evidence-based practice because there have been no empirical studies evaluating the effectiveness of PBF for promoting responsive feeding for parents and healthy intake and weight outcomes for infants. Thus, despite the conceptual promise of PBF for promoting responsive bottle-feeding interactions, research is needed to determine whether PBF is effective and identify whether any limitations of this method exist. This study is a within-subject, experimental study wherein mother-infant dyads will be observed during breastfeeding and typical bottle-feeding interactions. Mothers will then be taught the PBF method and observed during a PBF interaction. This design will allow for direct testing of the purported benefits of PBF over typical bottle-feeding and whether PBF makes the experience of bottle-feeding more equivalent to the experience of breastfeeding. The overarching aims of this study are to explore the ways in which bottle-feeding can go well and identify mechanisms through which bottle-feeding families can be supported to promote healthy intake and weight gain trajectories for their infants.
详细描述
Infancy is a sensitive period for obesity prevention efforts, in part because rapid weight gain during infancy is a stronger predictor of later obesity and metabolic comorbidities than weight gain trajectories during later life. The first 6 months are of particular importance given research illustrating overfeeding during this early window places infants at significantly higher risk for rapid weight gain compared to overfeeding during later infancy. To prevent overfeeding and rapid weight gain, current recommendations and prevention programs primarily focus on promoting responsive feeding during infant feeding interactions.
During responsive feeding, infants are fed in ways that are developmentally appropriate and responsive to infant hunger and fullness cues. Responsive feeding is widely recognized as the ideal way to feed infants because it gives them the scaffolded support to learn to recognize and eat in response to hunger and fullness cues and to self-regulate intake in response to physiological needs. Indeed, responsive feeding is associated with healthier eating behaviors and growth outcomes for infants.
Promotion of responsive feeding is typically a core component of breastfeeding promotion and education. However, a significant proportion of families bottle-feed their infants, either exclusively or in combination with breastfeeding. U.S. data illustrate 42% of infants are exclusively bottle-fed by 6 months of age and 70% of breastfed infants receive supplemental formula or bottle-feedings on a regular basis. Thus, bottle-feeding is a ubiquitous part of infant feeding and evidence-based strategies are needed to complement breastfeeding education and promote responsive bottle-feeding.
Unfortunately, many bottle-feeding families receive inadequate support for learning responsive bottle-feeding, likely because breastfeeding support is prioritized in health care settings. In addition, mothers perceive health professionals to be ill-prepared to help them with their formula- and bottle-feeding needs and reluctant to discuss formula- or bottle-feeding at the risk of compromising breastfeeding support. A striking 1 in 5 formula-feeding mothers reported they received no advice related to infant feeding from health care professionals compared to only 5% of breastfeeding mothers.
To date, few studies address this need, creating a significant research gap that hinders support for bottle-feeding families. Thus, promotion of responsive bottle-feeding remains a realistic but under-utilized facet of early support. One promising strategy is the "paced-bottle feeding" (PBF) method, which incorporates many concepts and strategies consistent with the concept of responsive feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
After each visit, three trained coders who are unaware of the experimental conditions and hypotheses of the study will score the videotaped records using an event recorder program (Observer XT, version 16; Noldus Information Technology, Heerlen, the Netherlands).
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Speaks English or Spanish
- •Mother 18-40-years of age
- •Infant 0-24 weeks of age
- •Dyad is current breastfeeding and bottle-feeding
- •Infant has not been introduced to solid foods
排除标准
- •Infant was born preterm (<37 weeks)
结局指标
主要结局
Change in Infant Milk Intake between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
时间窗: 3 visits across a 1 week period
Infant milk intake in mL, assessed by weighing the infant before and after each feeding condition
Change in Meal Duration between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
时间窗: 3 visits across a 1 week period
Duration of the observed meal in minutes (min), determined by trained video coders masked to study hypotheses
Change in Maternal Sensitivity to Infant Cues between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
时间窗: 3 visits across a 1 week period
Determined by video coders masked to study hypotheses and certified in the Nursing Child Assessment Caregiver-Child Interaction Feeding Scale (NCAFS); possible Maternal Sensitivity to Infant Cues scores range from 0-16 with higher scores representing greater maternal sensitivity to infant cues
Change in Maternal Responsiveness to Infant Distress between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
时间窗: 3 visits across a 1 week period
Determined by video coders masked to study hypotheses and certified in the Nursing Child Assessment Caregiver-Child Interaction Feeding Scale (NCAFS); possible Maternal Responsiveness to Infant Distress scores range from 0-11 with higher scores representing greater maternal responsiveness to infant distress
Change in Rate of Feeding between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
时间窗: 3 visits across a 1 week period
Infant milk intake divided by meal duration (mL/min)
Change in Frequency of Spitting Up During and After the Meal between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
时间窗: 3 visits across a 1 week period
Determined by trained video coders masked to study hypotheses
Change in Infant Clarity of Cues between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
时间窗: 3 visits across a 1 week period
Determined by video coders masked to study hypotheses and certified in the Nursing Child Assessment Caregiver-Child Interaction Feeding Scale (NCAFS); possible Infant Clarity of Cues scores range from 0-15 with higher scores representing greater infant clarity of cues
Change in Infant Responsiveness to Caregiver between Breastfeeding, Typical Bottle-Feeding, and Paced Bottle-Feeding Conditions
时间窗: 3 visits across a 1 week period
Determined by video coders masked to study hypotheses and certified in the Nursing Child Assessment Caregiver-Child Interaction Feeding Scale (NCAFS); possible Infant Responsiveness to Caregiver scores range from 0-11 with higher scores representing greater infant responsiveness to the caregiver
次要结局
未报告次要终点
研究者
Alison Ventura
Associate Professor
California Polytechnic State University-San Luis Obispo