Early Intervention for Cardiovascular Health

(ENRICH Trial)

Recruiting at 12 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

Trial Summary

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.

What data supports the effectiveness of the treatment Enriched home visiting for cardiovascular health?

Research shows that home visiting programs, like the ones involving nurses, can improve child and maternal health, enhance parenting, and increase the use of community resources. These programs have been effective in improving outcomes such as child development and maternal mental health, which suggests they could also positively impact cardiovascular health. ^{1 2 3 4 5}

Is the Early Intervention for Cardiovascular Health treatment safe for humans?

The interventions described, such as home visiting and family-oriented lifestyle modifications, have been used in various studies to promote cardiovascular health in children and families, and no safety concerns have been reported in these contexts. ^{6 7 8 9 10}

How is the 'Enriched home visiting' treatment unique for promoting cardiovascular health?

The 'Enriched home visiting' treatment is unique because it focuses on early intervention by integrating heart-healthy routines like diet, physical activity, and sleep into the daily lives of mothers and children, aiming to establish lifelong cardiovascular health from a young age. This approach is different from traditional treatments as it emphasizes community and family engagement through home visits, making it a personalized and sustainable strategy for reducing cardiovascular risk. ^{6 7 9 10 11}

What is the purpose of 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 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 '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]

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]

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 '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 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]

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) 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Systematic review: An exploration of core componentry characterizing effective sustained nurse home visiting programs. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Nurse Home Visiting for Families Experiencing Adversity: A Randomized Trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Nurse home visiting to improve child and maternal outcomes: 5-year follow-up of an Australian randomised controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The MOM Program: home visiting in partnership with pediatric care. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Home visitors and child health: analysis of selected programs. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Life Course Cardiovascular Health: Risk Factors, Outcomes, and Interventions. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular risk reduction in preschool children: the "Healthy Start" project. [2019]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Supporting early childhood routines to promote cardiovascular health across the life course. [2023]

10. United States 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The Prevention Education Program (PEP) Nuremberg: design and baseline data of a family oriented intervention study. [2014]