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Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) (ENRICH)

Primary Purpose

Cardiovascular Diseases, Infant ALL, Maternal Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Infant Cardiovascular Health (CVH) Promotion
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    All participants will be enrolled into the intervention arm of this pilot study.

    Outcomes

    Primary Outcome Measures

    Feasibility of integration of a cardiovascular health module into the existing Nurse-Family Partnership (NFP) home visiting program.
    Feasibility will be determined by acceptability of the curriculum to NFP nurses and participants as measured qualitatively through group discussion.

    Secondary Outcome Measures

    Number of participants consenting to participate in the pilot study.
    Enrollment feasibility will be determined by successful consent of 20 postpartum mother-infant dyads.
    Utility of infant foot worn actigraphy device for infant sleep data collection.
    Utility of device as demonstrated by days with complete sleep data.
    Number of participants completing maternal feeding data collection
    Determined by completion of study surveys.
    Participant intervention acceptability.
    Determined by completion of study qualitative surveys.

    Full Information

    First Posted
    March 24, 2023
    Last Updated
    April 21, 2023
    Sponsor
    Penn State University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05824741
    Brief Title
    Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
    Acronym
    ENRICH
    Official Title
    Promoting Cardiovascular Health of Northern Appalachian Mother-Infant Dyads: PSU Infant Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Penn State University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Infant ALL, Maternal Behavior, Childhood Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This pilot study is being conducted to inform feasibility of the next phase of this research project.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    All participants will be enrolled into the intervention arm of this pilot study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Infant Cardiovascular Health (CVH) Promotion
    Intervention Description
    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 Outcome Measure Information:
    Title
    Feasibility of integration of a cardiovascular health module into the existing Nurse-Family Partnership (NFP) home visiting program.
    Description
    Feasibility will be determined by acceptability of the curriculum to NFP nurses and participants as measured qualitatively through group discussion.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of participants consenting to participate in the pilot study.
    Description
    Enrollment feasibility will be determined by successful consent of 20 postpartum mother-infant dyads.
    Time Frame
    6 months
    Title
    Utility of infant foot worn actigraphy device for infant sleep data collection.
    Description
    Utility of device as demonstrated by days with complete sleep data.
    Time Frame
    1 year
    Title
    Number of participants completing maternal feeding data collection
    Description
    Determined by completion of study surveys.
    Time Frame
    1 year
    Title
    Participant intervention acceptability.
    Description
    Determined by completion of study qualitative surveys.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ian M Paul, MD, MSc
    Phone
    717-531-8006
    Email
    ipaul@pennstatehealth.psu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Richard S Legro, MD
    Phone
    717-531-8629
    Email
    rlegro@pennstatehealth.psu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ian M Paul, MD, MSc
    Organizational Affiliation
    Penn State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)

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