The Breastfeeding and Early Child Health (BEACH) Interview Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.
研究概览
简要总结
Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize; clinical study recruitment and retention, patient-centered outcomes, and stool collection procedures.
详细描述
This is an interview study that will enroll mothers during 28 weeks or greater of pregnancy and assess recruitment, patient-centered outcomes, and stool collection procedures via individualized interviews and data collection. Participants will be recruited from the greater Gainesville, FL area. Data collection will include questionnaires/surveys as well as minimal risk non-invasive biological samples such as stool, human milk, saliva, vaginal swab, and urine collection. Participants will be seen at a location convenient for them.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females 18>45, between 28-38 weeks pregnant, lives in Gainesville, Florida, and committed to exclusively breastfeeding through 6 months.
- •Females 18>45, actively breastfeeding for <12 months and lives in Gainesville, Florida
排除标准
- •Mothers who do not plan to exclusively breastfeed their infant for at least the first 6 months or actively breastfeeding.
- •Mothers who do not live in Gainesville, FL
- •Mothers who are not between the ages of 18-45
- •Mothers who are not between 28-38 weeks of gestation or a breastfeeding mother.
- •Mothers who have only one breast which is capable of producing milk and/or have a history of inadequate milk production.
- •Mothers who have consumed alcohol during this pregnancy.
- •Mothers who have abused drugs during this pregnancy.
- •Mothers who have smoked during this pregnancy.
- •Mothers who have been diagnosed with pre-eclampsia during this pregnancy.
- •Mothers who have had a previous pre-term delivery (baby born 2 months before the due date or <35 weeks).
结局指标
主要结局
Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.
时间窗: 6 months
Interviews will be analyzed to determine the efficacy of common strategies used to recruit pregnant and breastfeeding mothers into CRTs, challenges or barriers that would preclude women from enrolling and participating in CRTs, their preferences for incentives, as well their preference and methods related to non-invasive sample collection.
次要结局
- Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)(1 year)
- Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS)(1 year)
- Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)(1 year)