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

NCT05824741 | Completed Results

• 2 other identifiers: STUDY000215851UG3HL162971-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Infant ALL; Maternal Behavior; Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program.

  Feasibility will be determined by acceptability of the curriculum to NFP nurses and participants as measured qualitatively through group discussion. Nurses will qualitatively provide feedback to the study team on whether they are able to successfully deliver new materials to their home visitation clients.

  6 months

Secondary Outcomes (4)

• Number of Mothers Consenting for Their Infants to Participate in the Pilot Study.

  6 months

• Utility of Infant Foot Worn Actigraphy Device for Infant Sleep Data Collection.

  1 year

• Number of Participants Completing Maternal Feeding Data Collection

  1 year

• Participant Intervention Acceptability.

  1 year

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Infant Cardiovascular Health (CVH) Promotion

Interventions

Infant Cardiovascular Health (CVH) Promotion BEHAVIORAL

The pilot infant CVH intervention will be delivered by Nurse-Family Partnership (NFP) staff starting no later than 1 month postpartum and lasting 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. This pilot study will include an enhanced version of the NFP standard care plan delivered by trained nurses to promote cardiovascular health by targeting soothing, feeding, sleep, and physical activity behaviors during infancy. The intervention delivered by trained visiting nurses will include behavior change strategies (e.g., goal setting, problem solving barriers). This pilot study will also examine the feasibility and acceptability of a digital device (infant foot worn actigraphy) during this same time period.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Penn State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

UPMC Home Health

Altoona, Pennsylvania, 16601, United States

Location

Geisinger

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ian Paul
• Organization: Penn State College of Medicine

ipaul@pennstatehealth.psu.edu

(717) 531-8006

Study Officials

• Ian M Paul, MD, MSc

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Public Health Sciences; Chief, Division of Academic General Pediatrics; Vice Chair of Faculty Affairs, Department of Pediatrics

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

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 24, 2023
• Study Start: August 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Locations

US (2)