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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases Infant ALL Maternal Behavior Childhood Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Infant Cardiovascular Health (CVH) Promotion

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR