Early Cardiovascular Health Intervention for Pregnancy
(ENRICH Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byIan M Paul, MD, MSc

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Penn State University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for first-time pregnant women over 18, enrolled in the Nurse-Family Partnership program in Central Pennsylvania, who speak English and have confirmed singleton pregnancies. They must have reliable internet for data collection and some participants should be recent nicotine users.

Inclusion Criteria

English speaking

I have used nicotine products in the last 3 months.

Access to reliable internet service required for data collection

+4 more

Exclusion Criteria

I have been diagnosed with cancer.

I was born with a complex heart condition.

Participation in a concurrent interventional study

+2 more

Participant Groups

The study tests adding a cardiovascular health module to an existing home visitation program by nurses. It focuses on improving heart health during pregnancy in areas with less access to healthcare services.

1Treatment groups

Experimental Treatment

Group I: Maternal Cardiovascular health (CVH) InterventionExperimental Treatment1 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.