Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U24HL163114 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung & Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6618 participants in total (i.e., 3309 mother-child dyads which includes 3309 mothers and 3309 children) from diverse community settings with a high burden of cardiovascular disease risk factors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENRICHed home visiting | Experimental | Home Visiting with the addition of cardiovascular health promotion content |
|
| Usual Home Visiting | Active Comparator | Usual home visiting without cardiovascular health promotion content |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENRICH | Behavioral | In the ENRICH intervention, home visitors will incorporate heart health information and activities into routine home visits beginning in pregnancy and continuing until children turn 2 years old. The intervention includes 1) Information and resources on topics such as healthy eating, physical activity, weight management, tobacco use, healthy sleep and stress reduction, 2) tools like scales, Fitbits, and blood pressure monitors to facilitate self-monitoring, and 3) activities and information focused on infant nutrition, feeding, healthy growth, sleep, play and emotions and soothing. |
| Measure | Description | Time Frame |
|---|---|---|
| Parent physical activity | Time spent in moderate and vigorous physical activity in parent participants | 12 months after birth |
| Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale | Diet quality among parent participants as measured by Mediterranean Eating Pattern for Americans (MEPA) scale. The MEPA is a 16-item dietary screener designed to assess accordance with the Mediterranean-like diet patterns during the past 7 days among adults. A score of '0' will be given if the scoring condition is not met and a score of '1' will be given if the scoring condition is met. A score of '1' for any given item was indicative of Mediterranean-like diet accordance. If any condition was not met, a score of '0' was recorded for that item. The total MEPA score could range from 0 to 16. Scores will be converted to points on a 100-point scale based on quantiles of the 16-item measure. For example, scores from 0-3 (0 points), 4-7 (25 points), 8-11 (50 points), 12-14 (80 points), and 15-16 (100 points). Higher scores mean that the adult's diet is similar to a Mediterranean diet. | 12 months after birth |
| Parent body mass index | Body mass index (BMI) of parent participants | 12 months after birth |
| Parent blood pressure | blood pressure (BP) in parent participants | 12 months after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Child body mass index | body mass index in child | 24 months old |
Not provided
Inclusion Criteria:
Exclusion Criteria: There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori Burrell, MSW | Contact | 724-858-8201 | lburrel1@jh.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
cluster randomized at the home visiting supervisor level, stratified within home visiting agencies
Participants are masked throughout the study enrollment process (e.g., recruitment, consent, and baseline data collection). Participant may become unmasked to treatment arm after enrollment.
|
| Usual Home Visiting | Behavioral | Usual home visiting without cardiovascular health promotion content |
|
| California Polytechnic State University | Recruiting | San Luis Obispo | California | 93407 | United States |
|
| University of Colorado | Recruiting | Aurora | Colorado | 80204 | United States |
|
| Northwestern University | Recruiting | Chicago | Illinois | 60208 | United States |
|
| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63130 | United States |
|
| Wake Forest University | Recruiting | Winston-Salem | North Carolina | 27109 | United States |
|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15260 | United States |
|
| Pennsylvania State University | Recruiting | State College | Pennsylvania | 16801 | United States |
|
| Brown University/Lifespan | Recruiting | Providence | Rhode Island | 02903 | United States |
|