Cardiovascular HealthENRICHNCT06272045
Early Intervention to Promote Cardiovascular Health of Mothers and Children
A study testing ENRICH and Usual Home Visiting in people with Cardiovascular Health, run by JHSPH Center for Clinical Trials at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- ENRICH and Usual Home Visiting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,618 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Jun 2024to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80204
Natalie Murphy, 970-581-3018, NATALIE.MURPHY@CUANSCHUTZ.EDU
Mandy Allison
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Amy Dobelstein, 205-975-1059, adobelst@uabmc.edu
Gareth Dutton
- Recruiting
Northwestern University
Chicago, Illinois, 60208
Katharine Maroun, 312-503-3019, katharine.maroun@northwestern.edu
Darius Tandon
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Brianna Natale, 412-624-4020, bnn11@pitt.edu
Janet Catov
- Recruiting
Brown University/Lifespan
Providence, Rhode Island, 02903
Angelica McHugh, 401-793-8978, amchugh1@lifespan.org
Stephanie Parade
- Recruiting
California Polytechnic State University
San Luis Obispo, California, 93407
Noemi Alarcon, 805-756-5694, noalarco@calpoly.edu
Suzanne Phelan
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63130
Cindy Schwartz, 314-346-7101, cschwarz@wustl.edu
Debra Haire-Joshu
- Recruiting
Pennsylvania State University
State College, Pennsylvania, 16801
Lindsey Hess, 814-934-7631, lbb135@psu.edu
Ian Paul
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27109
Natalie Murphy, 970-581-3018, NATALIE.MURPHY@CUANSCHUTZ.EDU
Katherine Sauder
About this study
Official title: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
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.
- Conditions
- Cardiovascular Health
- Being tested
- ENRICH, Usual Home Visiting
- Keywords
- Home visiting, cardiovascular health, prevention, maternal-child health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENRICHBehavioural
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 VisitingBehavioural
Usual home visiting without cardiovascular health promotion content
| Study group | Role | What they receive |
|---|---|---|
| ENRICHed home visiting | Experimental | Home Visiting with the addition of cardiovascular health promotion content Receives: Behavioral: ENRICH |
| Usual Home Visiting | Active comparator | Usual home visiting without cardiovascular health promotion content Receives: Behavioral: Usual Home Visiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent physical activity
Time spent in moderate and vigorous physical activity in parent participants
Measured: 12 months after birth
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.
Measured: 12 months after birth
Parent body mass index
Body mass index (BMI) of parent participants
Measured: 12 months after birth
Parent blood pressure
blood pressure (BP) in parent participants
Measured: 12 months after birth
Secondary outcomes (1)
Child body mass index
body mass index in child
Measured: 24 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start19 Jun 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6,618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JHSPH Center for Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272045
- Sponsor's protocol ID
- IRB00398712
- Other IDs
- 5U24HL163114
- Acronym
- ENRICH
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
- ClinicalTrials.gov ID
- NCT06272045
- Acronym / sponsor ID
- ENRICH / IRB00398712
- Conditions
- Cardiovascular Health
- Keywords
- Home visiting, cardiovascular health, prevention, maternal-child health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,618 participants (estimated)
- Lead sponsor
- JHSPH Center for Clinical TrialsUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENRICHed home visiting | Experimental | Behavioral: ENRICHHome Visiting with the addition of cardiovascular health promotion content |
| Usual Home Visiting | Active comparator | Behavioral: Usual Home VisitingUsual home visiting without cardiovascular health promotion content |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENRICHIn 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. | Behavioural | ENRICHed home visiting |
| Usual Home VisitingUsual home visiting without cardiovascular health promotion content | Behavioural | Usual Home Visiting |
Primary outcome
Parent physical activity
Time frame: 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
Time frame: 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
Time frame: 12 months after birth
Body mass index (BMI) of parent participants
Parent blood pressure
Time frame: 12 months after birth
blood pressure (BP) in parent participants
1 secondary outcome
Child body mass index
Time frame: 24 months old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENRICH and Usual Home Visiting in people with Cardiovascular Health, run by JHSPH Center for Clinical Trials at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Burrell, MSW (724-858-8201, lburrel1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent physical activity (time frame: 12 months after birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.