Early Intervention to Promote Cardiovascular Health of Mothers and Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ENRICH, Usual Home Visiting.
- Who it may be relevant to
- Registry conditions: Cardiovascular Health. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
Overview
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.
Interventions
- Behavioral 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 focus - Behavioral Usual Home Visiting
Usual home visiting without cardiovascular health promotion content
Primary outcome measures
- Parent physical activity [Time frame: 12 months after birth]
- Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale [Time frame: 12 months after birth]
- Parent body mass index [Time frame: 12 months after birth]
- Parent blood pressure [Time frame: 12 months after birth]
Secondary outcome measures (1)
- Child body mass index [Time frame: 24 months old]
Eligibility criteria
Inclusion criteria
- 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
Exclusion Criteria: There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 9 centers
- University of Alabama at Birmingham — Birmingham
- California Polytechnic State University — San Luis Obispo
- University of Colorado — Aurora
- Northwestern University — Chicago
- Washington University in St. Louis — St Louis
- Wake Forest University — Winston-Salem
- University of Pittsburgh — Pittsburgh
- Pennsylvania State University — State College
- … and 1 more center
Identifiers
NCT: NCT06272045 · IRB00398712 · 5U24HL163114