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Completed

NCT Number: NCT05824741

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Home Health, Altoona, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Infant Cardiovascular Health (CVH) Promotion

Behavioral

The pilot infant CVH intervention will be delivered by Nurse-Family Partnership (NFP) staff starting no later than 1 month postpartum and lasting up to 6 months postpartum. The visit schedule will be consistent with the NFP visit structure to deliver intervention content at regularly scheduled visits that are typically 60 minutes long. 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 (infant foot worn actigraphy) during this same time period.

Primary outcomes

  1. 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

  1. Number of Mothers Consenting for Their Infants to Participate in the Pilot Study.

    Time frame: 6 months

    Enrollment feasibility will be determined by successful consent of 20 participants.

  2. Utility of Infant Foot Worn Actigraphy Device for Infant Sleep Data Collection.

    Time frame: 1 year

    Utility of device as demonstrated by days with complete sleep data.

  3. Number of Participants Completing Maternal Feeding Data Collection

    Time frame: 1 year

    Determined by completion of study surveys.

  4. Participant Intervention Acceptability.

    Time frame: 1 year

    Determined by completion of study qualitative surveys.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Promoting Cardiovascular Health of Northern Appalachian Mother-Infant Dyads: PSU Infant Pilot Study

Acronym: ENRICH

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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