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

Cardiovascular Diseases Clinical Trial

— ENRICH  

Official title:

Promoting Cardiovascular Health of Northern Appalachian Mother-Infant Dyads: PSU Infant Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824741
• Other study ID #: STUDY00021585
• Secondary ID: 1UG3HL162971-01
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Penn State University
• Contact: Ian M Paul, MD, MSc
• Phone: 717-531-8006
• Email: ipaul[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Childhood Obesity
• Infant ALL
• Maternal Behavior
• Pediatric Obesity

Intervention

Behavioral:
• Infant Cardiovascular Health (CVH) Promotion
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.

Locations

Country	Name	City	State
United States	UPMC Home Health	Altoona	Pennsylvania
United States	Geisinger	Danville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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