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El ensayo clínico NCT06272045 (ENRICH) para Salud cardiovascular está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06272045 (ENRICH) es un ensayo intervencionista para Salud cardiovascular. Su estado actual es: reclutando. El ensayo se inició el 19 de junio de 2024, con el objetivo de reclutar a 6618 participantes. Dirigido por JHSPH Center for Clinical Trials, se espera que finalice el 1 de julio de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 17 de octubre de 2025.
Resumen
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.
Título oficial
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
Condiciones médicas
Salud cardiovascularOtros ID del ensayo
- ENRICH
- IRB00398712
- 5U24HL163114 (Subvención/contrato NIH (EE. UU.))
Número del NCT
Inicio del ensayo (real)
2024-06-19
Última actualización
2025-10-17
Fecha de finalización (estimada)
2028-07
Inscripción (prevista)
6618
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
Home visiting, cardiovascular health, prevention, maternal-child health
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalENRICHed home visiting Home Visiting with the addition of cardiovascular health promotion content | ENRICH 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. |
Comparador activoUsual Home Visiting Usual home visiting without cardiovascular health promotion content | Usual Home Visiting Usual home visiting without cardiovascular health promotion content |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Child body mass index | body mass index in child | 24 months old |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer
Admisión de voluntarios sanos
Sí
- Be currently enrolled in an evidence-based home visiting program participating in ENRICH
- Be pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 days gestation (per self-report at time of consent)
- Be 18 years of age or older
- Speak English or Spanish
There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.
Contactos centrales del ensayo
Contacto: Lori Burrell, MSW, 724-858-8201, [email protected]
9 Sitios del ensayo en 1 países
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Amy Dobelstein, Contacto, 205-975-1059, [email protected]
Gareth Dutton, Investigador principal
Reclutando
California
California Polytechnic State University, San Luis Obispo, California, 93407, United States
Noemi Alarcon, Contacto, 805-756-5694, [email protected]
Suzanne Phelan, Investigador principal
Reclutando
Colorado
University of Colorado, Aurora, Colorado, 80204, United States
Natalie Murphy, Contacto, 970-581-3018, [email protected]
Mandy Allison, Investigador principal
Reclutando
Illinois
Northwestern University, Chicago, Illinois, 60208, United States
Katharine Maroun, Contacto, 312-503-3019, [email protected]
Darius Tandon, Investigador principal
Reclutando
Missouri
Washington University in St. Louis, St Louis, Missouri, 63130, United States
Cindy Schwartz, Contacto, 314-346-7101, [email protected]
Debra Haire-Joshu, Investigador principal
Reclutando
North Carolina
Wake Forest University, Winston-Salem, North Carolina, 27109, United States
Natalie Murphy, Contacto, 970-581-3018, [email protected]
Katherine Sauder, Investigador principal
Reclutando
Pennsylvania
University of Pittsburgh, Pittsburgh, Pennsylvania, 15260, United States
Brianna Natale, Contacto, 412-624-4020, [email protected]
Janet Catov, Investigador principal
Reclutando
Pennsylvania State University, State College, Pennsylvania, 16801, United States
Lindsey Hess, Contacto, 814-934-7631, [email protected]
Ian Paul, Investigador principal
Reclutando
Rhode Island
Brown University/Lifespan, Providence, Rhode Island, 02903, United States
Angelica McHugh, Contacto, 401-793-8978, [email protected]
Stephanie Parade, Investigador principal
Reclutando