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

Sponsor

Penn State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05824741

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Infant ALL Maternal Behavior Childhood Obesity	Behavioral: Infant Cardiovascular Health (CVH) Promotion	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention All participants will be enrolled into the intervention arm of this pilot study.	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.

Arm

Intervention/Treatment

Experimental: Intervention

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

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.

Outcome Measures

Primary Outcome Measures

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

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.
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 completing maternal feeding data collection [1 year]
Determined by completion of study surveys.
Participant intervention acceptability. [1 year]
Determined by completion of study qualitative surveys.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Ian M Paul, MD, MSc, Penn State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ian M. Paul, M.D., M.Sc., Professor of Pediatrics and Public Health Sciences; Chief, Division of Academic General Pediatrics; Vice Chair of Faculty Affairs, Department of Pediatrics, Penn State University

ClinicalTrials.gov Identifier:

NCT05824741

Other Study ID Numbers:

STUDY00021585
1UG3HL162971-01

First Posted:

Apr 24, 2023

Last Update Posted:

Apr 25, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Pediatric Obesity

Study Results

No Results Posted as of Apr 25, 2023