Cardiovascular Health
Conditions
Keywords
Home visiting, cardiovascular health, prevention, maternal-child health
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 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
BEHAVIORALENRICH
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.
BEHAVIORALUsual Home Visiting
Usual home visiting without cardiovascular health promotion content
Sponsors
JHSPH Center for Clinical Trials
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
cluster randomized at the home visiting supervisor level, stratified within home visiting agencies Participants are masked throughout the study enrollment process (e.g., recruitment, consent, and baseline data collection). Participant may become unmasked to treatment arm after enrollment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Be currently enrolled in an evidence-based home visiting program participating in ENRICH 2. Be pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 days gestation (per self-report at time of consent) 3. Be 18 years of age or older 4. Speak English or Spanish
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Parent blood pressure | 12 months after birth | blood pressure (BP) in parent participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child body mass index | 24 months old | body mass index in child |
Countries
United States
Contacts
CONTACTLori Burrell, MSW
Outcome results
None listed