nctId: NCT06272045 id: IRB00398712 id: 5U24HL163114-02 type: NIH link: https://reporter.nih.gov/quickSearch/5U24HL163114-02 briefTitle: Early Intervention to Promote Cardiovascular Health of Mothers and Children acronym: ENRICH overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-09 date: 2028-07 date: 2024-02-22 date: 2024-03-12 name: JHSPH Center for Clinical Trials class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: 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 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors. conditions: Cardiovascular Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: cluster randomized at the home visiting supervisor level, stratified within home visiting agencies whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 6400 type: ESTIMATED name: Enriched home visiting name: Routine home visiting measure: Parent physical activity measure: Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale measure: Parent body mass index measure: Parent blood pressure measure: Child body mass index sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: California Polytechnic Institute city: San Luis Obispo state: California zip: 93407 country: United States name: Noemi Alarcon role: CONTACT phone: 805-756-5694 email: noalarco@calpoly.edu name: Suzanne Phelan role: PRINCIPAL_INVESTIGATOR lat: 35.28275 lon: -120.65962 facility: Colorado University city: Aurora state: Colorado zip: 80045-7464 country: United States name: Katharine Gamalski role: CONTACT phone: 720-499-4501 email: katharine.gamalski@cuanschutz.edu name: Mandy Allison role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Northwestern University city: Chicago state: Illinois zip: 60208 country: United States name: Danielle Lorch role: CONTACT phone: 630-222-2194 email: dmlorch@northwestern.edu name: Darius Tandon role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Washington University city: Saint Louis state: Missouri zip: 63130 country: United States name: Cindy Schwartz role: CONTACT phone: 314-346-7101 email: cschwarz@wustl.edu name: Debra Haire-Joshu role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Wake Forest University city: Winston-Salem state: North Carolina zip: 27109 country: United States lat: 36.09986 lon: -80.24422 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15260 country: United States lat: 40.44062 lon: -79.99589 facility: Pennsylvania State University city: State College state: Pennsylvania zip: 16801 country: United States lat: 40.79339 lon: -77.86 facility: Lifespan city: Providence state: Rhode Island zip: 02903 country: United States name: Angelica McHugh role: CONTACT phone: 401-793-8978 email: amchugh1@lifespan.org name: Rena Wing role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 hasResults: False