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Early Cardiovascular Health Intervention for Pregnancy (ENRICH Trial)

N/A

Recruiting

Led By Ian M Paul, MD, MSc

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at adding a heart health module to a nurse-run home visit program in Central PA to see if it works and is accepted.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves education and lifestyle advice rather than medication, side effects are not typical as with drug trials but may include stress or anxiety related to lifestyle changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of integrating a cardiovascular health module to the existing Nurse-Family Partnership (NFP) home visiting program.

Secondary study objectives

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.

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.

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.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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