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

Not Applicable

Recruiting

• Conditions: Infant ALL; Cardiovascular Diseases; Childhood Obesity; Maternal Behavior
• Interventions: Behavioral: Infant Cardiovascular Health (CVH) Promotion

• Registration Number: NCT05824741
• Lead Sponsor: Penn State University

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 Mother-Infant Dyads: Pilot Study is a single arm pilot study that will enroll women with infants (\<1 month of age) 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 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 (actigraphy) during this same time period.

Study Timeline

• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-04-24
• Study Start: 2023-08-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion 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

Exclusion Criteria

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Infant Cardiovascular Health (CVH) Promotion	All participants will be enrolled into the intervention arm of this pilot study.

Primary Outcome Measures

Name	Time	Method
Feasibility of integration of a cardiovascular health module into the existing Nurse-Family Partnership (NFP) home visiting program.	6 months	Feasibility will be determined by acceptability of the curriculum to NFP nurses and participants as measured qualitatively through group discussion.

Secondary Outcome Measures

Name	Time	Method
Number of participants completing maternal feeding data collection	1 year	Determined by completion of study surveys.
Utility of infant foot worn actigraphy device for infant sleep data collection.	1 year	Utility of device as demonstrated by days with complete sleep data.
Number of participants consenting to participate in the pilot study.	6 months	Enrollment feasibility will be determined by successful consent of 20 postpartum mother-infant dyads.
Participant intervention acceptability.	1 year	Determined by completion of study qualitative surveys.

Trial Locations

Locations (2)

Geisinger; 🇺🇸 Danville, Pennsylvania, United States

UPMC Home Health; 🇺🇸 Altoona, Pennsylvania, United States