Cardiovascular DiseasesENRICHNCT05822531
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) During Pregnancy
A study testing Maternal CVH Intervention in people with Cardiovascular Diseases and Pregnancy Related, run by Penn State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Pregnancy Related, Sedentary Behavior
- What is being tested?
- Maternal CVH Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nulliparous pregnant woman
- Age ≥ 18 years old
- Enrolled in and receiving the Nurse-Family Partnership program through the Geisinger Clinic or UPMC Home Health Care of Central PA
- English speaking
- Women with a singleton viable pregnancy confirmed by NFP home visitors
- Access to reliable internet service required for data collection
- A minimum of 5 women with use of nicotine containing products (cigarette, cigar, hookah, chewing tobacco, e-cigarette, patch) within the past 3 months
Who cannot join
- Unable or unwilling to comply with the study visits and procedures
- Participation in a concurrent interventional study
- Diagnosis of cancer
- A personal history of complex congenital heart disease
- A fetus in the current pregnancy with known chromosomal abnormalities or birth defects inconsistent with survival to 2 years will be excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Home Health
Altoona, Pennsylvania, 16601
Geisinger
Danville, Pennsylvania, 17822
About this study
Official title: Promoting Cardiovascular Health of Northern Appalachian Women During and After Pregnancy: PSU Maternal Pilot Study
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.
Read the detailed description
The Promoting Cardiovascular Health of Northern Appalachian Women During and After Pregnancy: Pilot Study is a single arm pilot study that will enroll pregnant women (<28 weeks' gestation) 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 among women by targeting decreased sedentary time and enhanced physical activity (and where applicable smoking cessation) during and after pregnancy. This pilot study will also examine the feasibility and acceptability of digital devices (actigraphy, digital scale, blood pressure monitor) during this same time period.
- Being tested
- Maternal CVH Intervention
- Medical subject headings
- Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal CVH InterventionBehavioural
All participants will be enrolled into the intervention arm of this pilot study.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Cardiovascular health (CVH) Intervention | Experimental | 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. Receives: Behavioral: Maternal CVH Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Aug 2023
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This pilot study is being conducted to inform feasibility of the next phase of this research project.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ian M. Paul, M.D., M.Sc., Penn State University
- Investigators
- Ian M Paul, MD, MSc, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822531
- Sponsor's protocol ID
- STUDY00021577
- Other IDs
- 1UG3HL162971-01
- Acronym
- ENRICH
- Status last verified
- May 2025
- First submitted
- 24 Mar 2023
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Cardiovascular Health of Northern Appalachian Women During and After Pregnancy: PSU Maternal Pilot Study
- ClinicalTrials.gov ID
- NCT05822531
- Acronym / sponsor ID
- ENRICH / STUDY00021577
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Posted 29 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Promoting Cardiovascular Health of Northern Appalachian Women During and After Pregnancy: Pilot Study is a single arm pilot study that will enroll pregnant women (<28 weeks' gestation) 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 among women by targeting decreased sedentary time and enhanced physical activity (and where applicable smoking cessation) during and after pregnancy. This pilot study will also examine the feasibility and acceptability of digital devices (actigraphy, digital scale, blood pressure monitor) during this same time period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot study is being conducted to inform feasibility of the next phase of this research project.
| Arm | Type | Receives |
|---|---|---|
| Maternal Cardiovascular health (CVH) Intervention | Experimental | Behavioral: Maternal CVH InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Nulliparous pregnant woman
- Age ≥ 18 years old
- Enrolled in and receiving the Nurse-Family Partnership program through the Geisinger Clinic or UPMC Home Health Care of Central PA
- English speaking
- Women with a singleton viable pregnancy confirmed by NFP home visitors
Key exclusion criteria (5 listed)
- Unable or unwilling to comply with the study visits and procedures
- Participation in a concurrent interventional study
- Diagnosis of cancer
- A personal history of complex congenital heart disease
- A fetus in the current pregnancy with known chromosomal abnormalities or birth defects inconsistent with survival to 2 years will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal CVH InterventionAll participants will be enrolled into the intervention arm of this pilot study. | Behavioural | Maternal Cardiovascular health (CVH) Intervention |
Primary outcome
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.
Time frame: 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Paul, MD, MSc principal investigator
Penn State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal CVH Intervention in people with Cardiovascular Diseases and Pregnancy Related, run by Penn State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.