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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Pregnancy Related; Sedentary Behavior
• Intervention / Treatment: Behavioral: Maternal CVH Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16601
      • UPMC Home Health
    • Danville, Pennsylvania, United States, 17822
      • Geisinger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Nulliparous pregnant woman
2. Age ≥ 18 years old
3. Enrolled in and receiving the Nurse-Family Partnership program through the Geisinger Clinic or UPMC Home Health Care of Central PA
4. English speaking
5. Women with a singleton viable pregnancy confirmed by NFP home visitors
6. Access to reliable internet service required for data collection
7. 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:

1. Unable or unwilling to comply with the study visits and procedures
2. Participation in a concurrent interventional study
3. Diagnosis of cancer
4. A personal history of complex congenital heart disease
5. A fetus in the current pregnancy with known chromosomal abnormalities or birth defects inconsistent with survival to 2 years will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Maternal Cardiovascular health (CVH) Intervention; 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; All participants will be enrolled into the intervention arm of this pilot study.

What is the study measuring?

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 as Measured by Qualitative Feedback From Home Visitors.	Feasibility will be determined good acceptability by NFP nurses as assessed qualitatively during group discussions. Nurses will use their experience as home visitors to provide feedback to study personnel on whether they are able to successfully integrate new visit content into their usual workflow. They will further give suggestions for future improvement after completion of this pilot study.	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

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Ian M Paul, MD, MSc, Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: STUDY00021577; 1UG3HL162971-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No