Cardiovascular Diseases, Childhood Obesity, Infant ALL, Maternal 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 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.
Interventions
BEHAVIORALInfant 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.
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
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program. | 6 months | Feasibility will be determined by acceptability of the curriculum to NFP nurses and participants as measured qualitatively through group discussion. Nurses will qualitatively provide feedback to the study team on whether they are able to successfully deliver new materials to their home visitation clients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Mothers Consenting for Their Infants to Participate in the Pilot Study. | 6 months | Enrollment feasibility will be determined by successful consent of 20 participants. |
| Utility of Infant Foot Worn Actigraphy Device for Infant Sleep Data Collection. | 1 year | Utility of device as demonstrated by days with complete sleep data. |
| Number of Participants Completing Maternal Feeding Data Collection | 1 year | Determined by completion of study surveys. |
| Participant Intervention Acceptability. | 1 year | Determined by completion of study qualitative surveys. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Infants Behavioral intervention for parents of infants | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Intervention Group Infants |
|---|---|
| Age, Categorical <=18 years | 14 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 4 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 | 9 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program.
Feasibility will be determined by acceptability of the curriculum to NFP nurses and participants as measured qualitatively through group discussion. Nurses will qualitatively provide feedback to the study team on whether they are able to successfully deliver new materials to their home visitation clients.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program. | 14 participants receiving intervention |
Secondary
Number of Mothers Consenting for Their Infants to Participate in the Pilot Study.
Enrollment feasibility will be determined by successful consent of 20 participants.
Time frame: 6 months
Population: Participants enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number of Mothers Consenting for Their Infants to Participate in the Pilot Study. | 15 Participants enrolled |
Secondary
Number of Participants Completing Maternal Feeding Data Collection
Determined by completion of study surveys.
Time frame: 1 year
Secondary
Participant Intervention Acceptability.
Determined by completion of study qualitative surveys.
Time frame: 1 year
Secondary
Utility of Infant Foot Worn Actigraphy Device for Infant Sleep Data Collection.
Utility of device as demonstrated by days with complete sleep data.
Time frame: 1 year