COMPLETED

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

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Conditions

Cardiovascular DiseasesPregnancy RelatedSedentary Behavior

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05822531

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Nulliparous pregnant woman
  2. 2. Age ≥ 18 years old
  3. 3. Enrolled in and receiving the Nurse-Family Partnership program through the Geisinger Clinic or UPMC Home Health Care of Central PA
  4. 4. English speaking
  5. 5. Women with a singleton viable pregnancy confirmed by NFP home visitors
  6. 6. Access to reliable internet service required for data collection
  7. 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
  1. 1. Unable or unwilling to comply with the study visits and procedures
  2. 2. Participation in a concurrent interventional study
  3. 3. Diagnosis of cancer
  4. 4. A personal history of complex congenital heart disease
  5. 5. A fetus in the current pregnancy with known chromosomal abnormalities or birth defects inconsistent with survival to 2 years will be excluded

Contacts and Locations

Principal Investigator

Ian M Paul, MD, MSc
PRINCIPAL_INVESTIGATOR
Penn State University

Study Locations (Sites)

UPMC Home Health
Altoona, Pennsylvania, 16601
United States
Geisinger
Danville, Pennsylvania, 17822
United States

Collaborators and Investigators

Sponsor: Penn State University

  • Ian M Paul, MD, MSc, PRINCIPAL_INVESTIGATOR, Penn State University

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

Study Start Date2023-08-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiovascular Diseases
  • Pregnancy Related
  • Sedentary Behavior