Telephone Support Intervention to Improve Breastfeeding Rates in Low-Income Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 2
- 主要终点
- Breastfeeding at 3 months and at 6 months
研究概览
简要总结
This randomized controlled trial will evaluate an innovative telephone-based breastfeeding education and promotion intervention that will be implemented in a low-income, predominately Latina population. The trial will assess the impact of the intervention on duration of breastfeeding and exclusivity of breastfeeding at 1, 2, 3 and 6 months post-partum.
详细描述
This randomized controlled trial will evaluate an innovative telephone-based breastfeeding education and promotion intervention that will be implemented in a low-income, predominately Latina population. The intervention was developed in association with national breastfeeding experts, local public health department and WIC personnel and community leaders. Additionally, it will also be informed by focus groups that are currently being conducted in the community with a particular emphasis on cultural barriers to breastfeeding in Latina populations. The intervention consists of scripted education and support protocols delivered by telephone daily, in English and Spanish, by a trained nurse over the first two weeks after delivery and will be funded by the Division of General Pediatrics. In the evaluation mothers will be randomized during the first 24 hours after delivering a healthy baby to the intervention arm or to usual post-partum care. The trial will assess the impact of the intervention on duration of breastfeeding and exclusivity of breastfeeding at 1, 2, 3 and 6 months post-partum. In addition, it will assess cost-effectiveness of the intervention and secondary and process-of-care outcomes related to maternal satisfaction with feeding, confidence with breastfeeding and utilization of health services.
The specific aims of this project are:
- To evaluate in a randomized controlled trial the effect of a telephone-based breastfeeding support and education intervention compared to usual post-partum care on a) the duration of breastfeeding at 1, 2, 3 and 6 months and b) the exclusivity of breastfeeding at 1, 2, 3 and 6 months in low-income, primarily Latina women.
- To evaluate the cost-effectiveness of the telephone-based intervention compared to usual care
- To compare secondary outcomes for mothers in the intervention versus control groups such as maternal satisfaction and confidence with feeding, reasons for discontinuing breastfeeding and utilization of acute, preventive health care services and hospitalizations
- To better understand unmet needs in women who breastfeed and how well the intervention addressed these needs by conducting qualitative interviews
The major hypotheses are:
- a) Proactive telephone contact in the early postpartum period using scripted protocols will increase breastfeeding rates in low-income women from a current baseline of 30% to 45% at 3 months and from 20% to 35% at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •First time mother
- •Mother 18 years old or older
- •37 weeks gestation or greater at delivery
- •Intent to breastfeed
排除标准
- •mother's primary language is something other than English or Spanish
- •mother has medical complications that interfere with her instituting breastfeeding or require her to stay in the hospital for >72 hours
- •infant has a medical problem that requires admission to the intensive care nursery or requires hospitalization for >72 hours
- •mother expresses a strong desire to formula feed
结局指标
主要结局
Breastfeeding at 3 months and at 6 months
时间窗: 3 months and six months
次要结局
- Exclusively breastfeeding at 3 months and at 6 months(3 months and 6 months)
- Cost analysis: costs of training, costs of nurse for intervention, costs associated with intervention, cost of formula from WIC, time spent breastfeeding and time spent getting formula, acute care utilization associated with breastfeeding problems(6 months)
- Maternal satisfaction: 4-point Likert scale of satisfaction(6 months)
- Maternal confidence among breastfeeding mothers: Breastfeeding Self-Efficacy Short Form, 14-item scale scored 1-5, with range of scores from 14-70(3 months and 6 months)
- Reasons for stopping breastfeeding-descriptive data(6 months)
- Utilization outcomes: number of preventive care visits; number of acute visits for illness to clinic; number of emergency room visits; number of hospitalizations(6 months)
- Descriptive data regarding problems encountered, unmet needs, areas of strength and weakness of intervention and ways it could be improved.(6 months)