Clinical trial NCT05822531: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) During Pregnancy
Official title: Promoting Cardiovascular Health of Northern Appalachian Women During and After Pregnancy: PSU Maternal Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Pregnancy Related
Sedentary Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-20
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot study is being conducted to inform feasibility of the next phase of this research project.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Altoona
country: United States
facility: UPMC Home Health
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Ian M Paul, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: