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

RECRUITING

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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

Study Start (Actual) 2023-08-01

Primary Completion (Estimated) 2024-12

Study Completion (Estimated) 2024-12

Enrollment (Estimated) 20

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 Altoona, Pennsylvania, United States

📍 Danville, Pennsylvania, United States

Eligibility Criteria

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: Yes

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-03-24
First Submitted that Met QC Criteria2023-04-19
First Posted2023-04-20

Study Record Updates

Last Update Submitted that Met QC Criteria2023-11-14
Last Update Posted2023-11-15
Last Verified2023-11