Mom♥Health for Cardiovascular Disease

Overseen By Mark Bond

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cognitive impairment, Other trial participation

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program aimed at helping mothers reduce their risk of cardiovascular disease (heart-related health issues). The program, called Mom♥Health, is designed specifically for socially vulnerable mothers and involves phone-based sessions over 12 weeks, with a follow-up check-in six weeks later. Women who are primary caregivers of children aged five or younger and whose children attend certain childcare centers in New York may be a good fit. Participants need to speak English, Spanish, or Mandarin and should not currently participate in another behavioral study.

As an unphased trial, this offers participants the opportunity to contribute to innovative research that could significantly impact maternal 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.

What prior data suggests that the Mom♥Health program is safe for participants?

Research has shown that heart disease is a major health concern for new moms. The Mom♥Health program is being tested to help lower these risks. Specific safety data about the program is not available because it focuses on providing information and support, not medical treatments or drugs. The trial aims to help mothers who may need extra support by giving them tools to take care of their heart health. As an early-stage study, the program is still being tested and focuses mainly on prevention and education. This suggests that the program is likely safe for participants, as it involves offering support and information rather than medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mom♥Health for cardiovascular disease because it offers a novel approach by focusing on socially vulnerable mothers of young children. Unlike standard treatments that might involve medications or procedures directly targeting heart health, this program delivers support through telephone-based sessions over 12 weeks, emphasizing lifestyle changes and social support. This method aims to address the social determinants of health, which are often overlooked in traditional cardiovascular treatments, potentially leading to better long-term outcomes for both mothers and their families.

What evidence suggests that the Mom♥Health program is effective for cardiovascular disease prevention?

Research has shown that the Mom♥Health program, provided to participants in this trial, helps mothers lower their risk of heart disease by encouraging healthier lifestyle choices. Studies have found that similar programs boost confidence, making participants feel more capable of eating well and staying active. After participating in these programs, many people successfully adopt a healthier diet and exercise routine. This approach is particularly beneficial for women, as it addresses specific heart health risks they face. Early results suggest that focusing on these lifestyle changes can significantly reduce the risk of heart disease. ^{4 6 7 8 9}

Who Is on the Research Team?

Milla Arabadjian

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

The MomHeartHealth trial is for English, Spanish, or Mandarin-speaking women aged 21-49 who are primary caregivers of children under 5 attending certain NYU Langone childhood centers. They must be able to consent and not be in another behavioral trial or have significant cognitive impairment.

Inclusion Criteria

I identify as a woman.

I am between 21 and 49 years old.

I am the main caregiver for a child under 6 who goes to a specific center at NYU Langone.

Exclusion Criteria

Current participation in another behavioral clinical trial

I do not have significant memory or thinking problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline

Treatment

Socially vulnerable mothers receive telephone-delivered programs over 12 weeks

12 weeks

Telephone-delivered

Follow-up

Participants attend a post-intervention follow-up assessment

6 weeks

1 visit (in-person)

Outcome Assessment

Various outcome measures are assessed, including client satisfaction and health questionnaires

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mom♥Health

Trial Overview This study tests the Mom♥Health program aimed at preventing cardiovascular disease risk among mothers using two NYU Langone Family Health Centers as engagement platforms.

How Is the Trial Designed?

Group I: Socially Vulnerable Mothers Experimental Treatment 1 Intervention

Socially vulnerable mothers of young children, whose children attend formal childcare, will receive telephone-delivered programs over 12 weeks. They will also attend a 6 weeks post-intervention follow-up assessment.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

A new department is being established to focus on improving patient outcomes in cardiovascular care by addressing key issues like definitions, measurement, and data sources.

The initiative aims to foster discussion and research that will enhance understanding and practices related to nurse-sensitive and multidisciplinary outcomes in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes measurement. Deaton, C.[2019]

Patient outcome measures (POMs) are crucial for assessing the effectiveness of cardiac and pulmonary rehabilitation, but there is no universally accepted 'gold standard' POM, with the Global Mood Scale showing the highest responsiveness to changes in health status.

The SF-36 was commonly used but less effective in detecting changes, especially in mental health, while simpler questionnaires and Likert scales were found to be more responsive than complex or dichotomous scales in pre- to post-rehabilitation assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Effectiveness Review: RESPONSIVENESS OF PATIENT OUTCOME MEASURES IN CARDIAC AND PULMONARY REHABILITATION. van Rotterdam, J., Hensley, M., Hazelton, M.[2020]

Citations

1. withpower.com withpower.com/trial/phase-cardiovascular-diseases-3-2025-899c3

Mom♥Health for Cardiovascular Disease This single-site research study will pilot-test a context-specific cardiovascular disease (CVD) risk prevention program, Mom♥Health, using two childhood ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6554792/

OR21-4 Heart Health 4 Moms: A Randomized Trial to ... Primary outcomes were self-efficacy for healthy eating and increasing physical activity; change in physical activity/inactivity; adherence to the Dietary ...

3. newsroom.heart.org newsroom.heart.org/news/20-million-awarded-for-research-to-improve-outcomes-in-pregnancy-infant-cvd-health

$20 million awarded for research to improve outcomes in ... $20 million awarded for research to improve outcomes in pregnancy, infant CVD health | American Heart Association.

4. mckinsey.com mckinsey.com/mhi/our-insights/the-state-of-us-womens-heart-health-a-path-to-improved-health-and-financial-outcomes

The state of US women's heart health Closing the cardiovascular-disease gap between men and women could help women regain 1.6 million years of life lost because of poor health and early death.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8020477/

Results of a prospective cardiovascular disease prevention ... After program intervention, a majority of participants showed that they were able to adhere to their integrative action plan, especially regarding diet, ...

6. acc.org acc.org/About-ACC/Press-Releases/2025/03/25/10/19/Maternal-Deaths-From-CV-Causes-On-the-Rise-in-US

Maternal Deaths From Cardiovascular Causes On the Rise ... The rate of maternal mortality related to cardiovascular causes more than doubled between 1999 and 2022 in the United States, according to a study.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40812624/

Pregnancy outcomes in women with the highest ... Although pregnancy in women with mWHO Class IV disease carries substantial risk, favourable outcomes are achievable in a tertiary centre ...

8. professional.heart.org professional.heart.org/en/education/role-of-cardiovascular-health-in-maternal-health

Role of Cardiovascular Health in Maternal Health Pregnancy-related deaths in the U.S. have increased by 140% over the past 30 years, with cardiovascular disease as the leading cause. Increase your knowledge ...

9. goredforwomen.org goredforwomen.org/en/about-heart-disease-in-women/facts

The Facts about Women and Heart Disease Cardiovascular disease is the No. 1 killer of new moms and accounts for over on-third of maternal deaths.