protocolSection identificationModule nctId: NCT06272045, orgStudyIdInfo id: IRB00398712, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: JHSPH Center for Clinical Trials, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule 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., conditionsModule conditions: Cardiovascular Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: cluster randomized at the home visiting supervisor level, stratified within home visiting agencies, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 6400, type: ESTIMATED, armsInterventionsModule interventions name: Enriched home visiting, interventions name: Routine home visiting, outcomesModule primaryOutcomes measure: Parent physical activity, primaryOutcomes measure: Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale, primaryOutcomes measure: Parent body mass index, primaryOutcomes measure: Parent blood pressure, secondaryOutcomes measure: Child body mass index, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: California Polytechnic Institute, city: San Luis Obispo, state: California, zip: 93407, country: United States, contacts name: Noemi Alarcon, role: CONTACT, phone: 805-756-5694, email: noalarco@calpoly.edu, contacts name: Suzanne Phelan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.28275, lon: -120.65962, locations facility: Colorado University, city: Aurora, state: Colorado, zip: 80045-7464, country: United States, contacts name: Katharine Gamalski, role: CONTACT, phone: 720-499-4501, email: katharine.gamalski@cuanschutz.edu, contacts name: Mandy Allison, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Northwestern University, city: Chicago, state: Illinois, zip: 60208, country: United States, contacts name: Danielle Lorch, role: CONTACT, phone: 630-222-2194, email: dmlorch@northwestern.edu, contacts name: Darius Tandon, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Washington University, city: Saint Louis, state: Missouri, zip: 63130, country: United States, contacts name: Cindy Schwartz, role: CONTACT, phone: 314-346-7101, email: cschwarz@wustl.edu, contacts name: Debra Haire-Joshu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Wake Forest University, city: Winston-Salem, state: North Carolina, zip: 27109, country: United States, geoPoint lat: 36.09986, lon: -80.24422, locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15260, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Pennsylvania State University, city: State College, state: Pennsylvania, zip: 16801, country: United States, geoPoint lat: 40.79339, lon: -77.86, locations facility: Lifespan, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Angelica McHugh, role: CONTACT, phone: 401-793-8978, email: amchugh1@lifespan.org, contacts name: Rena Wing, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False