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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sedentary Behavior Reduction in Pregnancy Intervention Study

NCT05093842

Pregnancy Complications Sedentary Behavior

COMPLETED NA

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

NCT05655936

Preeclampsia Hypertensive Disorder of Pregnancy Toxemia +11 more

RECRUITING NA

The DC Mother-Infant Behavioral Wellness Program

NCT05345834

Perinatal Depression Perinatal Anxiety Prenatal Stress

ACTIVE_NOT_RECRUITING NA

Virtual Mentorship to Support Maternal and Infant Health and Wellbeing: Assessing the Impact and Efficacy of NurturePA

NCT03497286

Mothers

COMPLETED NA

Prevention of Postpartum Depression in Low-Income Women

NCT00053651

Depression, Postpartum

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Pregnancy Related Sedentary Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Maternal Cardiovascular health (CVH) 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.

Group Type EXPERIMENTAL

Maternal CVH Intervention

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Maternal CVH Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ian M. Paul, M.D., M.Sc.

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

Responsibility Role PRINCIPAL_INVESTIGATOR