Early Intervention for Cardiovascular Health

(ENRICH Trial)

Recruiting at 13 trial locations

Overseen By Lori Burrell, MSW

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: JHSPH Center for Clinical Trials

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

6618 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how adding cardiovascular health tips to home visits can improve heart health for mothers and their young children. Researchers are testing two approaches: one group receives regular home visits, while the other receives visits with added heart health advice, known as "Enriched home visiting." The trial targets pregnant women in a home visiting program who speak English or Spanish. The goal is to find better ways to support heart health and reduce health disparities in diverse communities. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies for improving community health.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that home visiting programs like the one in this study are generally safe. These programs provide extra health information and support during home visits without involving new drugs or medical procedures, which often carry more risks. Instead, they aim to improve health by offering education and resources.

There are no specific reports of negative effects from these types of programs. Since the trial does not involve testing a new drug or surgery, the chance of unexpected side effects is lower. Participants usually find these programs easy to handle. However, it is always important to monitor feedback from participants to ensure they feel comfortable and safe during the program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how enhanced home visiting can improve cardiovascular health. Unlike standard home visits, which typically don't focus on heart health, the ENRICHed home visiting program includes specific content aimed at promoting cardiovascular well-being. This approach is unique because it integrates health education directly into home visits, potentially offering a more personalized and preventive strategy to tackle heart-related issues early on. By embedding cardiovascular health promotion into regular home care, researchers hope to see better long-term health outcomes for participants.

What evidence suggests that this trial's treatments could be effective for cardiovascular health?

This trial will compare two approaches to home visiting programs. Participants in the ENRICHed home visiting arm will receive home visits with added cardiovascular health promotion content, including advice on diet, exercise, and stress management. Research has shown that such enriched programs can improve heart health for mothers and children, aiming to lower problems like high blood pressure and heart disease risks. Meanwhile, the Usual Home Visiting arm will provide standard home visits without the additional cardiovascular content. Evidence suggests that enriched home visits can also help reduce health disparities in communities with high heart disease risks, positively affecting families' long-term health by focusing on simple lifestyle changes. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals enrolled in certain home visiting programs, less than 34 weeks into their pregnancy, and aged 18 or older. They must speak English or Spanish. There are no specific exclusions, so a wide range of people can participate.

Inclusion Criteria

Currently enrolled in an evidence-based home visiting program participating in ENRICH

Pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 days gestation (per self-report at time of consent)

Exclusion Criteria

There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Home visiting intervention to promote cardiovascular health in mothers and children

12 months

Regular home visits

Follow-up

Participants are monitored for cardiovascular health outcomes after the intervention

12 months

Extended Follow-up

Monitoring of child body mass index until 24 months old

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Enriched home visiting
• Routine home visiting

Trial Overview The ENRICH study is comparing the effects of two types of home visits on cardiovascular health: 'enriched' visits with additional support and routine visits. The goal is to see if enriched visits can improve heart health for mothers and children in communities at high risk.

How Is the Trial Designed?

Group I: ENRICHed home visiting Experimental Treatment 1 Intervention

Home Visiting with the addition of cardiovascular health promotion content

Group II: Usual Home Visiting Active Control 1 Intervention

Usual home visiting without cardiovascular health promotion content

Enriched home visiting is already approved in United States for the following indications:

Approved in United States as ENRICH for:

• Cardiovascular health promotion in mothers and children
• Reduction of disparities in maternal and early childhood cardiovascular health

Who Is Running the Clinical Trial?

JHSPH Center for Clinical Trials

Lead Sponsor

Trials

14

Recruited

11,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Research shows that cardiovascular health (CVH) in early life, including prenatal and childhood factors, is crucial for predicting long-term health outcomes such as cardiovascular disease and mortality.

Interventions to improve CVH are rare, especially for children, highlighting the need for effective, scalable, and community-engaged strategies to promote cardiovascular health from an early age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life Course Cardiovascular Health: Risk Factors, Outcomes, and Interventions. Pedamallu, H., Zmora, R., Perak, AM., et al.[2023]

The Prevention Education Program (PEP) is a long-term, home-based intervention aimed at improving cardiovascular health in children and their families, involving 1740 families across 37 schools over a 10-year period.

Baseline data revealed a high prevalence of cardiovascular risk factors among both adults and children, highlighting the urgent need for this type of intervention in Germany.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevention education program (PEP). A prospective study of the efficacy of family-oriented life style modification in the reduction of cardiovascular risk and disease: design and baseline data. Schwandt, P., Geiss, HC., Ritter, MM., et al.[2022]

The 'right@home' nurse home visiting program in Australia showed positive long-term effects on children's language, learning, and overall family wellbeing, with 62% of participants in the intervention group providing data at 5 years.

The program demonstrated significant benefits in maternal mental health and parenting relationships, suggesting that NHV can effectively support families facing adversity within a universal healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse home visiting to improve child and maternal outcomes: 5-year follow-up of an Australian randomised controlled trial. Goldfeld, S., Bryson, H., Mensah, F., et al.[2023]

Establishing heart-healthy routines in early childhood, such as proper diet, physical activity, and sleep, can significantly enhance both lifespan and quality of life, according to research.

A systematic approach to promoting these routines can help improve long-term cardiovascular health and reduce inequalities in health outcomes, highlighting the importance of early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting early childhood routines to promote cardiovascular health across the life course. Kim, L., Duh-Leong, C., Nagpal, N., et al.[2023]

The Prevention Education Program (PEP) involved 3547 adults and 3495 children over a 10-year period, revealing that children have cardiovascular risk factors similar to adults, such as hypertension (20%) and obesity (19%).

Both children and adults in the study followed diets high in fat (38% of total energy) and low in carbohydrates, indicating that dietary interventions could be crucial for early prevention of cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prevention Education Program (PEP) Nuremberg: design and baseline data of a family oriented intervention study. Ohrig, E., Geiss, HC., Haas, GM., et al.[2014]

The right@home nurse home visiting program significantly improved parenting practices and the home environment for children at age 2, with notable increases in regular bedtimes, safety, and warm parenting among participants.

In a randomized controlled trial involving 722 pregnant women facing adversity, the program demonstrated effectiveness in enhancing key determinants of children's health and development, suggesting it could be scaled and integrated into existing health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse Home Visiting for Families Experiencing Adversity: A Randomized Trial. Goldfeld, S., Price, A., Smith, C., et al.[2019]

The Family Matters study is a randomized controlled trial involving 525 children aged 5-10 at risk for cardiovascular disease, aiming to improve child cardiovascular health by increasing the frequency and quality of family meals through innovative methods like ecological momentary intervention and video feedback.

This study is unique as it combines multiple intervention strategies, including home visits by Community Health Workers, to evaluate their effectiveness in enhancing diet quality and overall health outcomes, potentially influencing future clinical practices in child cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Three-Arm Randomized Controlled Trial Using Ecological Momentary Intervention, Community Health Workers, and Video Feedback at Family Meals to Improve Child Cardiovascular Health: The Family Matters Study Design. Berge, JM., Trofholz, AC., Aqeel, M., et al.[2023]

The 'Healthy Start' intervention, which modified food services in nine Head Start centers, led to a significant decrease in total serum cholesterol among preschool children, with a reduction of -6.0 mg/dL compared to only -0.4 mg/dL in control groups.

Children with initially elevated cholesterol levels who participated in the food service modification were 30% less likely to remain at risk for elevated cholesterol, demonstrating the intervention's effectiveness in promoting heart health without negatively impacting short-term growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular risk reduction in preschool children: the "Healthy Start" project. Williams, CL., Strobino, BA., Bollella, M., et al.[2019]

The MOM Program, a randomized controlled trial involving 302 mothers and their infants, demonstrated that home visiting significantly increased the likelihood of keeping pediatric appointments, with home-visited mothers being over 10 times more likely to attend these visits compared to those who did not receive home visits.

The study highlights the effectiveness of integrating home visiting programs with pediatric care, suggesting that such partnerships can enhance child health outcomes and warrant further exploration and expansion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The MOM Program: home visiting in partnership with pediatric care. Radcliffe, J., Schwarz, D., Zhao, H.[2013]

Home visitor programs have been shown to positively impact child health outcomes, including increased birth weight, better prenatal care, and enhanced maternal-infant interaction, suggesting their effectiveness in supporting families.

Pediatricians can play a crucial role in promoting these programs by referring families, advising on program development, advocating for funding, and participating in multidisciplinary efforts to create new initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home visitors and child health: analysis of selected programs. Chapman, J., Siegel, E., Cross, A.[2022]

A systematic review of seven sustained nurse home visiting (SNHV) programs identified seven key components that contribute to their effectiveness in improving maternal and child health outcomes, including starting visits during pregnancy and providing at least 19 scheduled visits with qualified nurses.

These findings can help establish best-practice guidelines for SNHV programs, ensuring they are tailored to meet the needs of disadvantaged families and ultimately improving health outcomes and reducing inequities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: An exploration of core componentry characterizing effective sustained nurse home visiting programs. Beatson, R., Molloy, C., Perini, N., et al.[2021]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10833025

Early Intervention to Promote Cardiovascular Health ... Evidence-based home visiting (HV) provides an ideal setting to reduce health disparities, reduce maternal morbidity, and promote CVH in infants and children in ...

2. school.wakehealth.edu school.wakehealth.edu/departments/implementation-science/healthy-lifestyles/enrich-study

ENRICH: Early Intervention to Promote Cardiovascular Health ... The trial is testing whether training home visitors to enrich their current practice with new materials can improve the cardiovascular health of mothers and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05856162?term=AREA%5BBasicSearch%5D(northwestern%20university)&rank=9

Early Intervention to Promote Cardiovascular Health of ... The full ENRICH pilot intervention will consist of content related to diet, physical activity, stress/mental health, sleep, tobacco cessation, and child health.

4. hvresearch.org hvresearch.org/enrich/

ENRICH - HARC The purpose of ENRICH is to test the effectiveness of an implementation-ready intervention, delivered in the context of early childhood home visiting.

5. pure.psu.edu pure.psu.edu/en/projects/early-intervention-to-promote-cardiovascular-health-of-mothers-an-3

Early Intervention to Promote Cardiovascular Health of ... This research will test an implementation-ready intervention designed to improve cardiovascular health (CVH) among high risk mothers and young children.

6. hvenrich.org hvenrich.org/

ENRICH ENRICH aims to test the effectiveness of an intervention designed to promote cardiovascular health and address cardiovascular health disparities in both ...