Early Intervention to Promote Cardiovascular Health of Mothers and Children
- Conditions
- Cardiovascular Health
- Interventions
- Behavioral: Usual Home VisitingBehavioral: ENRICH
- Registration Number
- NCT06272045
- Lead Sponsor
- JHSPH Center for Clinical Trials
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 6618
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Home Visiting Usual Home Visiting Usual home visiting without cardiovascular health promotion content ENRICHed home visiting ENRICH Home Visiting with the addition of cardiovascular health promotion content
- Primary Outcome Measures
Name Time Method Parent blood pressure 12 months after birth blood pressure (BP) in parent participants
Parent physical activity 12 months after birth Time spent in moderate and vigorous physical activity in parent participants
Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale 12 months after birth 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.
Parent body mass index 12 months after birth Body mass index (BMI) of parent participants
- Secondary Outcome Measures
Name Time Method Child body mass index 24 months old body mass index in child
Trial Locations
- Locations (9)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Pennsylvania State University
🇺🇸State College, Pennsylvania, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
California Polytechnic State University
🇺🇸San Luis Obispo, California, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Brown University/Lifespan
🇺🇸Providence, Rhode Island, United States