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

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Infant ALL; Childhood Obesity; Maternal Behavior; Cardiovascular Diseases

Treatments: Behavioral: Infant Cardiovascular Health (CVH) Promotion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05824741

STUDY00021585

1UG3HL162971-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Infant Cardiovascular Health (CVH) Promotion