Trial Outcomes & Findings for Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) (NCT NCT05824741)
NCT ID: NCT05824741
Last Updated: 2025-05-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
6 months
Results posted on
2025-05-29
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline data not collected on 1 participant
Baseline characteristics by cohort
| Measure |
Intervention Group Infants
n=15 Participants
Behavioral intervention for parents of infants
|
|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=14 Participants • Baseline data not collected on 1 participant
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=14 Participants • Baseline data not collected on 1 participant
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants • Baseline data not collected on 1 participant
|
|
Sex: Female, Male
Female
|
10 Participants
n=14 Participants • Baseline data not collected on 1 participant so no information on race/ethnicity/sex
|
|
Sex: Female, Male
Male
|
4 Participants
n=14 Participants • Baseline data not collected on 1 participant so no information on race/ethnicity/sex
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 6 monthsFeasibility 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.
Outcome measures
| Measure |
Intervention
n=14 Participants
All participants 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.
|
|---|---|
|
Feasibility of Integration of a Cardiovascular Health Module Into the Existing Nurse-Family Partnership (NFP) Home Visiting Program.
|
14 participants receiving intervention
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants enrolled
Enrollment feasibility will be determined by successful consent of 20 participants.
Outcome measures
| Measure |
Intervention
n=15 Participants
All participants 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.
|
|---|---|
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Number of Mothers Consenting for Their Infants to Participate in the Pilot Study.
|
15 Participants enrolled
|
SECONDARY outcome
Timeframe: 1 yearUtility of device as demonstrated by days with complete sleep data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearDetermined by completion of study surveys.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearDetermined by completion of study qualitative surveys.
Outcome measures
Outcome data not reported
Adverse Events
Intervention Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place