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

NCT05822531 | Completed Results

• 2 other identifiers: STUDY000215771UG3HL162971-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiovascular Diseases; Pregnancy Related; Sedentary Behavior

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Maternal Cardiovascular health (CVH) Intervention

EXPERIMENTAL

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

Interventions

Maternal CVH Intervention BEHAVIORAL

All participants will be enrolled into the intervention arm of this pilot study.

Maternal Cardiovascular health (CVH) Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

UPMC Home Health

Altoona, Pennsylvania, 16601, United States

Location

Geisinger

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Ian Paul
• Organization: Penn State College of Medicine

ipaul@pennstatehealth.psu.edu

(717) 531-8006

Study Officials

• Ian M Paul, MD, MSc

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Public Health Sciences; Chief, Division of Academic General Pediatrics; Vice Chair of Faculty Affairs, Department of Pediatrics Affiliation: Penn State University

Model Details: This pilot study is being conducted to inform feasibility of the next phase of this research project.

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 20, 2023
• Study Start: August 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Locations

US (2)