CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Infant Cardiovascular Health (CVH) Promotionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05824741
NCT05824741N/ACompleted

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

Penn State University·interventional·Posted Apr 24, 2023·Updated May 29, 2025

In Brief

A clinical study evaluating Infant Cardiovascular Health (CVH) Promotion for Cardiovascular Diseases and 3 related conditions. Completed, enrolled 15 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedApr 24, 2023
Enrollment StartAug 1, 2023
Primary CompletionJun 30, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.2 years ago

Interventions

Infant Cardiovascular Health (CVH) Promotionbehavioral

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.