Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 2
- 主要终点
- Breastfeeding intensity at 1,3, and 6 months
研究概览
简要总结
We will conduct a randomized, controlled trial of routine, pre-natal care practice-site based pre- and post-natal breastfeeding promotion interventions in low-income minority women, with stratification for maternal country of origin. Our primary outcome measure is breastfeeding duration and extent, i.e. "intensity." Our secondary outcomes measures are: a) infant weight, and b) participant/ provider experiences of the intervention.
The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study (PAIRINGS) trial randomizes women to a Prenatal Care Provider (PNC) + Lactation Consultant (LC) intervention, or Control group. The PNCs will use a brief, computer prompted protocol throughout pregnancy and at follow-up of maternal-infant dyads. The LC will meet women, one-on-one while pregnant, at daily hospital rounds, during well-infant care and (as needed) home visits. Post-partum interviews at 1,3 and 6 months will collect infant feeding data.
Primary Outcomes (Hypotheses): Breastfeeding
- Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences, by treatment group, in BF intensity. Intensity will be assessed via 7 day recall of the frequency of breastmilk feedings vs. other liquids and solids.
- Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences, by treatment group, in the rate of exclusive BF.
Secondary Outcomes (Hypotheses): Infant Growth 3. Weight-for-Length, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight-for-length z scores at 4,6,9, and 12 month well-child visits. 4. Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age. 5. Weight-for-Length, by Treatment Group: There will be a significant association between treatment group and weight-for-length z scores at 4,6,9, and 12 month well-child visits 6. Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.
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
- Single (Outcomes Assessor)
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
- •12-30 weeks pregnant
- •receives prenatal care at Centennial women's center of Montefiore Medical Center
- •English or Spanish speaking
排除标准
- •pregnant with multiples
- •breastfeeding contra-indicated
研究组 & 干预措施
2
Standard of Care
1
Receipt of behavioral interventions to encourage breastfeeding.
干预措施: LC and Electronic Prompt (Behavioral)
结局指标
主要结局
Breastfeeding intensity at 1,3, and 6 months
时间窗: 1,3, and 6 months after birth of the baby
次要结局
- Infant growth by treatment group and breastfeeding intensity(Assessed when baby is 1,3, and 6 months of age)
研究者
Karen Bonuck
Professor
Albert Einstein College of Medicine
