Promoting Cardiovascular Health of Northern Appalachian Mother-Infant Dyads: PSU Infant Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Penn State University
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program.
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
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
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program.
Time Frame: 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.
Secondary Outcomes
- 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)