Cardiovascular Diseases, Pregnancy Related, Sedentary Behavior
Conditions
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.
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.
Interventions
BEHAVIORALMaternal CVH Intervention
All participants will be enrolled into the intervention arm of this pilot study.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Penn State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This pilot study is being conducted to inform feasibility of the next phase of this research project.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Nulliparous pregnant woman 2. Age ≥ 18 years old 3. Enrolled in and receiving the Nurse-Family Partnership program through the Geisinger Clinic or UPMC Home Health Care of Central PA 4. English speaking 5. Women with a singleton viable pregnancy confirmed by NFP home visitors 6. Access to reliable internet service required for data collection 7. A minimum of 5 women with use of nicotine containing products (cigarette, cigar, hookah, chewing tobacco, e-cigarette, patch) within the past 3 months
Exclusion criteria
1. Unable or unwilling to comply with the study visits and procedures 2. Participation in a concurrent interventional study 3. Diagnosis of cancer 4. A personal history of complex congenital heart disease 5. A fetus in the current pregnancy with known chromosomal abnormalities or birth defects inconsistent with survival to 2 years will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Maternal Cardiovascular Health (CVH) Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: 6 months
Population: Qualitative feedback from nurses
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maternal Cardiovascular Health (CVH) Intervention | 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 |