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Lo studio clinico NCT06272045 (ENRICH) per Salute cardiovascolare è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
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La sperimentazione clinica NCT06272045 (ENRICH) è uno studio interventistico per Salute cardiovascolare, attualmente in arruolamento. Avviato il 19 giugno 2024, prevede di arruolare 6.618 partecipanti. Sotto la guida di JHSPH Center for Clinical Trials, dovrebbe concludersi entro il 1 luglio 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 17 ottobre 2025.
Sommario breve
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.
Titolo ufficiale
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
Condizioni
Salute cardiovascolareAltri ID dello studio
- ENRICH
- IRB00398712
- 5U24HL163114 (Sovvenzione/Contratto NIH (USA))
Numero NCT
Data di inizio (effettiva)
2024-06-19
Ultimo aggiornamento pubblicato
2025-10-17
Data di completamento (stimata)
2028-07
Arruolamento (previsto)
6.618
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Home visiting, cardiovascular health, prevention, maternal-child health
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleENRICHed 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. |
Comparatore attivoUsual Home Visiting Usual home visiting without cardiovascular health promotion content | Usual Home Visiting Usual home visiting without cardiovascular health promotion content |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Child body mass index | body mass index in child | 24 months old |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Donna
Accetta volontari sani
Sì
- 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.
Contatti principali dello studio
Contatto: Lori Burrell, MSW, 724-858-8201, [email protected]
9 Centri dello studio in 1 paesi
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Amy Dobelstein, Contatto, 205-975-1059, [email protected]
Gareth Dutton, Investigatore principale
In arruolamento
California
California Polytechnic State University, San Luis Obispo, California, 93407, United States
Noemi Alarcon, Contatto, 805-756-5694, [email protected]
Suzanne Phelan, Investigatore principale
In arruolamento
Colorado
University of Colorado, Aurora, Colorado, 80204, United States
Natalie Murphy, Contatto, 970-581-3018, [email protected]
Mandy Allison, Investigatore principale
In arruolamento
Illinois
Northwestern University, Chicago, Illinois, 60208, United States
Katharine Maroun, Contatto, 312-503-3019, [email protected]
Darius Tandon, Investigatore principale
In arruolamento
Missouri
Washington University in St. Louis, St Louis, Missouri, 63130, United States
Cindy Schwartz, Contatto, 314-346-7101, [email protected]
Debra Haire-Joshu, Investigatore principale
In arruolamento
North Carolina
Wake Forest University, Winston-Salem, North Carolina, 27109, United States
Natalie Murphy, Contatto, 970-581-3018, [email protected]
Katherine Sauder, Investigatore principale
In arruolamento
Pennsylvania
University of Pittsburgh, Pittsburgh, Pennsylvania, 15260, United States
Brianna Natale, Contatto, 412-624-4020, [email protected]
Janet Catov, Investigatore principale
In arruolamento
Pennsylvania State University, State College, Pennsylvania, 16801, United States
Lindsey Hess, Contatto, 814-934-7631, [email protected]
Ian Paul, Investigatore principale
In arruolamento
Rhode Island
Brown University/Lifespan, Providence, Rhode Island, 02903, United States
Angelica McHugh, Contatto, 401-793-8978, [email protected]
Stephanie Parade, Investigatore principale
In arruolamento