Promoting Cardiovascular Health of Northern Appalachian Mother-Infant Dyads: PSU Infant Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program.
研究概览
简要总结
This pilot study aims to examine the feasibility and acceptability of adding a cardiovascular health module to the existing Nurse Family Partnership (NFP) home visitation program delivered by trained nurses in the Northern Appalachian region of Central Pennsylvania.
详细描述
The Promoting Cardiovascular Health of Northern Appalachian Mother-Infant Dyads: Pilot Study is a single arm pilot study that will enroll women with infants (<1 month of age) participating in the NFP home visitation program in the Northern Appalachian region of Central Pennsylvania. This pilot study will include an enhanced version of the NFP standard care plan delivered by trained nurses to promote cardiovascular health by targeting soothing, feeding, sleep, and physical activity behaviors during infancy. The intervention delivered by trained visiting nurses will include behavior change strategies (e.g., goal setting, problem solving barriers). This pilot study will also examine the feasibility and acceptability of a digital device (actigraphy) during this same time period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother-infant dyad enrolled in and receiving the Nurse Family Partnership program through one of the study teams community partner offices throughout Central Pennsylvania
- •Mother age ≥ 18 years at time of delivery
- •Mother English speaking
- •Singleton infant born at ≥ 35 weeks' gestation
- •Infant age < 1 month at time of consent
- •Mother with reliable access to the internet for consent and data collection purposes
排除标准
- •Unable or unwilling to comply with the study visits and procedures.
- •Participation in a concurrent intervention study.
- •Infants with known chromosomal abnormalities, complex congenital heart disease, or birth defects inconsistent with survival to age 2 years.
- •Infant with substantial feeding difficulty (e.g., those requiring tube feeding)
结局指标
主要结局
Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program.
时间窗: 6 months
Feasibility will be determined by acceptability of the curriculum to NFP nurses and participants as measured qualitatively through group discussion. Nurses will qualitatively provide feedback to the study team on whether they are able to successfully deliver new materials to their home visitation clients.
次要结局
- Number of Participants Completing Maternal Feeding Data Collection(1 year)
- Participant Intervention Acceptability.(1 year)
- Number of Mothers Consenting for Their Infants to Participate in the Pilot Study.(6 months)
- Utility of Infant Foot Worn Actigraphy Device for Infant Sleep Data Collection.(1 year)
研究者
Ian M. Paul, M.D., M.Sc.
Professor of Pediatrics and Public Health Sciences; Chief, Division of Academic General Pediatrics; Vice Chair of Faculty Affairs, Department of Pediatrics
Penn State University