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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3HL162971-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | All participants will be enrolled into the intervention arm of this pilot study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Cardiovascular Health (CVH) Promotion | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Mothers Consenting for Their Infants to Participate in the Pilot Study. | Enrollment feasibility will be determined by successful consent of 20 participants. | 6 months |
| Utility of Infant Foot Worn Actigraphy Device for Infant Sleep Data Collection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian M Paul, MD, MSc | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Home Health | Altoona | Pennsylvania | 16601 | United States | ||
| Geisinger |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Infants | All infants will be enrolled into the intervention arm of this pilot study. Infant 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group Infants | Behavioral intervention for parents of infants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Baseline data not collected on 1 participant |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants receiving intervention | 6 months |
|
6 months
Infant adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Behavioral intervention for parents of infants | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Paul | Penn State College of Medicine | (717) 531-8006 | ipaul@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 8, 2023 | Apr 18, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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This pilot study is being conducted to inform feasibility of the next phase of this research project.
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|
Utility of device as demonstrated by days with complete sleep data. |
| 1 year |
| Number of Participants Completing Maternal Feeding Data Collection | Determined by completion of study surveys. | 1 year |
| Participant Intervention Acceptability. | Determined by completion of study qualitative surveys. | 1 year |
| Danville |
| Pennsylvania |
| 17822 |
| United States |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Baseline data not collected on 1 participant so no information on race/ethnicity/sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
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| 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. | Participants enrolled | Posted | Number | Participants enrolled | 6 months |
|
|
|
| Secondary | Utility of Infant Foot Worn Actigraphy Device for Infant Sleep Data Collection. | Utility of device as demonstrated by days with complete sleep data. | Not Posted | 1 year | Participants |
| Secondary | Number of Participants Completing Maternal Feeding Data Collection | Determined by completion of study surveys. | Not Posted | 1 year | Participants |
| Secondary | Participant Intervention Acceptability. | Determined by completion of study qualitative surveys. | Not Posted | 1 year | Participants |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |