Telephone Support From Primary Care to Breastfeeding Mothers: A Randomized and Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 434
- 试验地点
- 2
- 主要终点
- Rate of exclusive breastfeeding
研究概览
简要总结
The investigators will conduct a telephone-based support to breastfeeding women with healthy newborns to improve breastfeeding outcomes.
详细描述
The World Health Organization recommends exclusive breastfeeding to infants until 6 months of age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers at 6 months is only 24.7 in Spain. The investigators believe it is important to increase the proportion of breastfeeding mothers in their population. Therefore, the investigators have developed a telephonic support protocol for mothers. The intervention will be performed by pediatric nurses in Primary Care.
The main aim of this study is to evaluate in a randomized controlled trial the effectiveness of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to evaluate the effectiveness of the telephonic support in any breastfeeding.
The investigators hypothesis is that this intervention will increase exclusive breastfeeding and any breastfeeding rates.
The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants will include breastfeeding women who have full-term healthy infants. Mothers will be recruited upon their first arrival to Primary Care from hospital. Eligible mothers who consent to participate will be randomized into either the intervention group or the control group. The latter will receive standard postpartum care. The former will receive standard postpartum care, plus a weekly telephone call during the first two months and every 2 weeks thereafter between the second and the sixth month. The pediatric nurse responsible for monitoring the standard care of each and every patient will be the one responsible for contacting them via telephone. Therefore, the study is not blinded.
The evolution of exclusive breastfeeding will be compared to artificial or supplemented feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding supplemented with formula will also be valued. Classification into breastfeeding categories is based on 24-hour dietary recall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Mothers with healthy newborns
- •37 weeks gestation or greater
- •Exclusive breastfeeding or any breastfeeding when arrive at Primary Care
排除标准
- •Infant or mother admitted in ICU
- •Twin pregnancy
- •Major congenital malformation of babies
- •Mothers age <= 18
- •Inability to understand Spanish/Catalan
- •Mothers who don't have a telephone
- •Mothers who don't give her consent
研究组 & 干预措施
Experimental
These mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support
干预措施: Telephone support (Behavioral)
No intervention
Standard care (office visits at 1, 2, 4 and 6 months)
结局指标
主要结局
Rate of exclusive breastfeeding
时间窗: 6 months
Exclusive breastfeeding at 6 months. (time frame: 6 months)
次要结局
- Rate of exclusive breastfeeding(1 month)