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

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 Women During and After Pregnancy: Pilot Study is a single arm pilot study that will enroll pregnant women (<28 weeks' gestation) 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 among women by targeting decreased sedentary time and enhanced physical activity (and where applicable smoking cessation) during and after pregnancy. This pilot study will also examine the feasibility and acceptability of digital devices (actigraphy, digital scale, blood pressure monitor) during this same time period.

Official Title
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Promoting Cardiovascular Health of Northern Appalachian Women During and After Pregnancy: PSU Maternal Pilot Study

Conditions
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Cardiovascular Diseases, Pregnancy Related, Sedentary Behavior

Intervention / Treatment
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* Behavioral: Maternal CVH Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous pregnant woman Age ≥ 18 years old Enrolled in and receiving the Nurse-Family Partnership program through the Geisinger Clinic or UPMC Home Health Care of Central PA English speaking Women with a singleton viable pregnancy confirmed by NFP home visitors Access to reliable internet service required for data collection A minimum of 5 women with use of nicotine containing products (cigarette, cigar, hookah, chewing tobacco, e-cigarette, patch) within the past 3 months Exclusion Criteria: Unable or unwilling to comply with the study visits and procedures Participation in a concurrent interventional study Diagnosis of cancer A personal history of complex congenital heart disease A fetus in the current pregnancy with known chromosomal abnormalities or birth defects inconsistent with survival to 2 years will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Maternal Cardiovascular health (CVH) Intervention<br>The pilot maternal CVH intervention will be delivered by NFP partners starting as early as NFP program enrollment in the first trimester after confirmation of a viable pregnancy and no later than the 28th week of pregnancy and will continue 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 (weekly visits for the first month following enrollment followed by twice monthly visits until delivery). The pilot study will include an enhanced behavioral component target decreased sedentary time and increase physical activity and utilizing a technology/monitoring component. All women be monitored using a wrist-worn actigraphy device to record daily activity, intermittent home blood pressure self-monitoring, intermittent home weight self-monitoring, and carbon monoxide monitoring administered by the NFP nurse. | Behavioral: Maternal CVH Intervention<br>* All participants will be enrolled into the intervention arm of this pilot study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of integrating a cardiovascular health module to the existing Nurse-Family Partnership (NFP) home visiting program. | Feasibility will be determined good acceptability by NFP nurses as assessed qualitatively during group discussions. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability of using a wrist-worn actigraphy device to record daily activity during and after pregnancy as measured by days with complete actigraphy data. | Determined successful uptake and demonstrable utility of device as measured by days with complete data. | 6 months | 
| Feasibility and acceptability of using a digital scale for intermittent home self-monitoring of body weight during and after pregnancy as measured by days with recorded body weight. | Determined successful uptake and demonstrable utility of device as measured by days with complete data of body weight. | 6 months | 
| Feasibility and acceptability of using a monitor for intermittent home self-monitoring of blood pressure during and after pregnancy as measured by days of recorded data. | Determined successful uptake and demonstrable utility of device as demonstrated by days with complete data. | 6 months | 
| Feasibility and acceptability using a carbon monoxide monitor to assess baseline carbon monoxide levels with continued monitoring of elevated levels as measured by days with recorded measurements. | Determined successful uptake and demonstrable utility of device as measured by participants with completed assessments. | 6 months |