COMPLETED

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

Conditions

Cardiovascular Diseases Infant ALL Maternal Behavior Childhood Obesity

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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 Mother-Infant Dyads: PSU Infant 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

NCT05824741

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:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Mother-infant dyad enrolled in and receiving the Nurse Family Partnership program through one of the study teams community partner offices throughout Central Pennsylvania 2. Mother age ≥ 18 years at time of delivery 3. Mother English speaking 4. Singleton infant born at ≥ 35 weeks' gestation 5. Infant age \< 1 month at time of consent 6. Mother with reliable access to the internet for consent and data collection purposes	1. Unable or unwilling to comply with the study visits and procedures. 2. Participation in a concurrent intervention study. 3. Infants with known chromosomal abnormalities, complex congenital heart disease, or birth defects inconsistent with survival to age 2 years. 4. Infant with substantial feeding difficulty (e.g., those requiring tube feeding)

Inclusion Criteria

Exclusion Criteria

1. Mother-infant dyad enrolled in and receiving the Nurse Family Partnership program through one of the study teams community partner offices throughout Central Pennsylvania
2. Mother age ≥ 18 years at time of delivery
3. Mother English speaking
4. Singleton infant born at ≥ 35 weeks' gestation
5. Infant age \< 1 month at time of consent
6. Mother with reliable access to the internet for consent and data collection purposes

1. Unable or unwilling to comply with the study visits and procedures.
2. Participation in a concurrent intervention study.
3. Infants with known chromosomal abnormalities, complex congenital heart disease, or birth defects inconsistent with survival to age 2 years.
4. Infant with substantial feeding difficulty (e.g., those requiring tube feeding)

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
Infant ALL
Maternal Behavior
Childhood Obesity