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

Cardiovascular Diseases Clinical Trial

— ENRICH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822531
• Other study ID #: STUDY00021577
• Secondary ID: 1UG3HL162971-01
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Penn State University
• Contact: Ian M Paul, MD, MSc
• Phone: 717-531-8006
• Email: ipaul[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Pregnancy Related
• Sedentary Behavior

Intervention

Behavioral:
• Maternal CVH Intervention
All participants will be enrolled into the intervention arm of this pilot study.

Locations

Country	Name	City	State
United States	UPMC Home Health	Altoona	Pennsylvania
United States	Geisinger	Danville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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