Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
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.
Conditions:
🦠 Cardiovascular Diseases 🦠 Infant ALL 🦠 Maternal Behavior 🦠 Childhood Obesity
🗓️ Study Start (Actual) 1 August 2023
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Altoona, Pennsylvania, United States
📍 Danville, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Mother-infant dyad enrolled in and receiving the Nurse Family Partnership program through one of the study teams community partner offices throughout Central Pennsylvania
    • 2. Mother age ≥ 18 years at time of delivery
    • 3. Mother English speaking
    • 4. Singleton infant born at ≥ 35 weeks' gestation
    • 5. Infant age \< 1 month at time of consent
    • 6. Mother with reliable access to the internet for consent and data collection purposes

    Exclusion Criteria:

    • 1. Unable or unwilling to comply with the study visits and procedures.
    • 2. Participation in a concurrent intervention study.
    • 3. Infants with known chromosomal abnormalities, complex congenital heart disease, or birth defects inconsistent with survival to age 2 years.
    • 4. Infant with substantial feeding difficulty (e.g., those requiring tube feeding)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 March 2023
  • First Submitted that Met QC Criteria 19 April 2023
  • First Posted 24 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 November 2023
  • Last Update Posted 15 November 2023
  • Last Verified November 2023