The Effect of Physical Contact on Maternal Responsiveness and Breastfeeding Outcomes Among Low Income Mothers Participating in the California Border Healthy Start Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nurturely
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Proportion of infant feeds coming from breastmilk versus formula
研究概览
简要总结
To test the hypothesis that increased mother-infant physical contact affects the likelihood of mothers exclusively breastfeeding their child for the first six months of life, the investigators will randomly assign half of the participating mothers to receive a baby carrier to use with their baby (to facilitate increased physical contact) while the other half of babies and mothers will receive standard care.
详细描述
One hundred mothers participating in the California Border Healthy Start (CBHS) program will be randomly assigned to the physical contact group or the control group. Mothers in the physical contact group will be provided with an infant carrier to use from birth to facilitate increased mother-infant physical contact. In the control group, mothers will be provided with an infant carrier, but will not receive the carrier until postpartum week 24, once study measures have been collected. This type of multiple-baseline design will allow the investigators to objectively assess the effect of physical contact during the first six months, but will also ensure that mothers in both groups have the opportunity to benefit from the potentially positive intervention of a high quality infant carrier to promote increased mother-infant physical contact. The two groups will be compared on: 1) likelihood of exclusive breastfeeding, 2) extent of breastfeeding exclusivity (proportion of feeds that are breastmilk versus formula or other), 3) likelihood of initiating feeding in response to hunger cues versus crying (i.e., maternal responsiveness during feeding), 4) maternal score on the Edinburgh Postnatal Depression Scale (EPDS), 5) prevalence of breastfeeding difficulties, 6) score on the Mother-Infant Bonding Scale, and 7) beliefs about breastfeeding and infant care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To be eligible to participate in this study, participants:
- •Must be a current participant in the CBHS program
- •Must be 18 years of age or older
- •Must be currently pregnant
- •Must be fluent in either Spanish or English
- •Must have consistent access to a smartphone with internet access (to fill out surveys and feeding logs)
- •Must have a functioning email address Must be willing to share certain personal information with the researchers
排除标准
- •Having a birth that does not result in a live, healthy, singleton infant.
结局指标
主要结局
Proportion of infant feeds coming from breastmilk versus formula
时间窗: Postpartum Week 24
Self-report feeding log
次要结局
- Score on the Proximal Care Beliefs Questionnaire(Postpartum Week 12)
- Score on Edinburgh Postnatal Depression Scale (EPDS)(Postpartum Week 6)
- Score on the Mother-Infant Bonding Questionnaire(Postpartum Week 24)
