Health TrialsbyHealthPanel

Early Intervention to Promote Cardiovascular Health of Mothers and Children

ConditionCardiovascular Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJHSPH Center for Clinical Trials

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • ENRICH

    Behavioral

    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.

  • Usual Home Visiting

    Behavioral

    Usual home visiting without cardiovascular health promotion content

Treatment groups

6,618 Participants
are divided into 2 treatment groups
Group A: ENRICHed home visitingExperimental treatment 1 intervention
Group B: Usual Home VisitingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Parent physical activity

Time spent in moderate and vigorous physical activity in parent participants

Time frame
12 months after birth
2

Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale

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.

Time frame
12 months after birth
3

Parent body mass index

Body mass index (BMI) of parent participants

Time frame
12 months after birth
4

Parent blood pressure

blood pressure (BP) in parent participants

Time frame
12 months after birth

Secondary outcomes

1

Child body mass index

body mass index in child

Time frame
24 months old

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

JHSPH Center for Clinical Trials

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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