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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases, Infant ALL, Maternal Behavior, Childhood Obesity

Intervention / Treatment
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* Behavioral: Infant Cardiovascular Health (CVH) Promotion


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: This pilot study is being conducted to inform feasibility of the next phase of this research project.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>All participants will be enrolled into the intervention arm of this pilot study. | Behavioral: Infant Cardiovascular Health (CVH) Promotion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants consenting to participate in the pilot study. | Enrollment feasibility will be determined by successful consent of 20 postpartum mother-infant dyads. | 6 months | 
| Utility of infant foot worn actigraphy device for infant sleep data collection. | Utility of device as demonstrated by days with complete sleep data. | 1 year | 
| Number of participants completing maternal feeding data collection | Determined by completion of study surveys. | 1 year | 
| Participant intervention acceptability. | Determined by completion of study qualitative surveys. | 1 year |