Clinical trial NCT05824741: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
Official title: Promoting Cardiovascular Health of Northern Appalachian Mother-Infant Dyads: PSU Infant Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Infant ALL
Maternal Behavior
Childhood Obesity
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot study is being conducted to inform feasibility of the next phase of this research project.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program.
timeFrame: 6 months
Secondary outcomes:
measure: Number of Mothers Consenting for Their Infants to Participate in the Pilot Study.
timeFrame: 6 months
measure: Utility of Infant Foot Worn Actigraphy Device for Infant Sleep Data Collection.
timeFrame: 1 year
measure: Number of Participants Completing Maternal Feeding Data Collection
timeFrame: 1 year
measure: Participant Intervention Acceptability.
timeFrame: 1 year
Other outcomes:
Locations:
city: Altoona
country: United States
facility: UPMC Home Health
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Ian M Paul, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: