N/A
Completed N=15
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
Cardiovascular Disease · Infant ALL · Maternal Behavior · Obesity
Source: ClinicalTrials.gov NCT05824741 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program. — 14 participants receiving intervention
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program. |
14 | — |
| SECONDARY Number of Mothers Consenting for Their Infants to Participate in the Pilot Study. |
15 | — |
| SECONDARY Utility of Infant Foot Worn Actigraphy Device for Infant Sleep Data Collection. |
— | — |
| SECONDARY Number of Participants Completing Maternal Feeding Data Collection |
— | — |
| SECONDARY Participant Intervention Acceptability. |
— | — |
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)
Data sourced from ClinicalTrials.gov (NCT05824741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.