Trial Outcomes & Findings for Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) During Pregnancy (NCT NCT05822531)

Last Updated: 2025-05-29

Results Overview

Feasibility will be determined good acceptability by NFP nurses as assessed qualitatively during group discussions. Nurses will use their experience as home visitors to provide feedback to study personnel on whether they are able to successfully integrate new visit content into their usual workflow. They will further give suggestions for future improvement after completion of this pilot study.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

6 months

Results posted on

2025-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Maternal Cardiovascular Health (CVH) Intervention The pilot maternal CVH intervention will be delivered by NFP partners starting as early as NFP program enrollment in the first trimester after confirmation of a viable pregnancy and no later than the 28th week of pregnancy and will continue 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 (weekly visits for the first month following enrollment followed by twice monthly visits until delivery). The pilot study will include an enhanced behavioral component target decreased sedentary time and increase physical activity and utilizing a technology/monitoring component. All women be monitored using a wrist-worn actigraphy device to record daily activity, intermittent home blood pressure self-monitoring, intermittent home weight self-monitoring, and carbon monoxide monitoring administered by the NFP nurse.
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maternal Cardiovascular Health (CVH) Intervention n=12 Participants The pilot maternal CVH intervention will be delivered by NFP partners starting as early as NFP program enrollment in the first trimester after confirmation of a viable pregnancy and no later than the 28th week of pregnancy and will continue 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 (weekly visits for the first month following enrollment followed by twice monthly visits until delivery). The pilot study will include an enhanced behavioral component target decreased sedentary time and increase physical activity and utilizing a technology/monitoring component. All women be monitored using a wrist-worn actigraphy device to record daily activity, intermittent home blood pressure self-monitoring, intermittent home weight self-monitoring, and carbon monoxide monitoring administered by the NFP nurse.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Qualitative feedback from nurses

Outcome measures

Outcome measures
Measure	Maternal Cardiovascular Health (CVH) Intervention n=7 Participants The pilot maternal CVH intervention will be delivered by NFP partners starting as early as NFP program enrollment in the first trimester after confirmation of a viable pregnancy and no later than the 28th week of pregnancy and will continue 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 (weekly visits for the first month following enrollment followed by twice monthly visits until delivery). The pilot study will include an enhanced behavioral component target decreased sedentary time and increase physical activity and utilizing a technology/monitoring component. All women be monitored using a wrist-worn actigraphy device to record daily activity, intermittent home blood pressure self-monitoring, intermittent home weight self-monitoring, and carbon monoxide monitoring administered by the NFP nurse.
Feasibility of Integrating a Cardiovascular Health Module to the Existing Nurse-Family Partnership (NFP) Home Visiting Program as Measured by Qualitative Feedback From Home Visitors.	7 Participants reporting success

Adverse Events

Pregnancy Loss

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ian Paul

Penn State College of Medicine

Phone: (717) 531-8006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place