Assessing the Feasibility of a Breastfeeding Champion Intervention and a Positive Messaging Module During the Prenatal Period - a Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Number of Participants Who Reported Their Intervention as "Very Interesting" (Response=5) on a 5 Point Likert Scale
研究概览
简要总结
Background: Exclusive breastfeeding through age 6 months is the optimal infant feeding method due to lifesaving benefits for children and mothers (AAP, others). Exclusive breastfeeding in-hospital is critical because in-hospital formula supplementation doubles risk of non-exclusive breastfeeding at 30-60 days (Chantry et al, 2014). While breastfeeding initiation rates have increased at our inner-city Baby Friendly - designated maternity hospital, exclusive breastfeeding lags. CDC mPINC data (maternity practices in infant nutrition and care, 2015) demonstrate this is a national problem, with >50% of surveyed hospitals endorsing supplementation of "10-49%" of breastfed infants.
Study Objective: The study objective is to evaluate acceptance/satisfaction of 2 prenatal interventions (breastfeeding champion and positive messaging) and to determine if these affect exclusive breastfeeding intention and practice.
Methods: In this prospective intervention study with follow-up chart review, we will pilot two 5-minute-long iPad-based interventions for 1 month each in obstetrical clinics, following a required 28-week obstetrical visit breastfeeding education. All expectant mothers (including 14-17 year olds with guardian) are eligible. Outcomes are acceptance (enrollment rate), satisfaction (Likert-based), impact on exclusive breastfeeding intention (pre/post query) and secondarily impact on exclusive breastfeeding in-hospital and at 2 weeks.
详细描述
Relevance:
This research is aligned with efforts to decrease infant mortality and associated racial disparities via culturally competent interventions, and our aim is that it will be possible to model a larger intervention trial using the data generated in this pilot study. The project showcases work which is clinically meaningful, addresses an important racial health disparity in a vulnerable population (predominantly African-American expectant women) and is allied with hospital quality measures (PC-05, exclusive breastfeeding in hospital).
Background:
Exclusive breastfeeding through age 6 months is the optimal infant feeding method due to lifesaving benefits for children and mothers (AAP, others). Exclusive breastfeeding in-hospital is critical because in-hospital formula supplementation doubles risk of non-exclusive breastfeeding at 30-60 days (Chantry et al, 2014). While breastfeeding initiation rates have increased at our inner-city Baby Friendly - designated maternity hospital, exclusive breastfeeding lags. CDC mPINC data (maternity practices in infant nutrition and care, 2015) demonstrate this is a national problem, with >50% of surveyed hospitals endorsing supplementation of "10-49%" of breastfed infants.
Study Objective and Aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Expectant women receiving prenatal care at UH MacDonald Women's Health Clinic or MAC1200 CLinic
- •Completed required breastfeeding education presented at or before 28 weeks of gestation
- •Age 14 - 17 years must have guardian/parent present who consents to teen participation, and teen must then assent to participation
- •Ages 18 years and older must consent to participate
排除标准
- •Medical indication for use of formula only after delivery including HIV+ or will require chemotherapy treatment
结局指标
主要结局
Number of Participants Who Reported Their Intervention as "Very Interesting" (Response=5) on a 5 Point Likert Scale
时间窗: 15 minutes
Single 5 point Likert scale with query "Was the intervention you received interesting and enjoyable?" Analyzed as all those who said 5 "very interesting" on a 5 point Likert scale; higher score indicates the participant liked/was more interested in the intervention; minimum score =1, maximum score = 5; No scale title - Question was: Was the intervention you received interesting and enjoyable? Please give us your overall impression on a scale from 1-5!
Number of Participants Who Intended to Exclusively Breastfeed Post-intervention
时间窗: 15 minutes
Single query "How do you plan to feed your baby?" with 4 possible responses Just formula / Both breastmilk and formula / Just breastmilk / Unsure
次要结局
- Number of Participants Who Exclusively Breastfed In-hospital(2 days)
- Number of Participants Who Exclusively Breastfed at 2 Weeks Postpartum(2 weeks)
研究者
Lydia Furman
Professor of Pediatrics
University Hospitals Cleveland Medical Center