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

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.

What data supports the effectiveness of the treatment Mom♥Health for cardiovascular disease?

The research highlights the importance of patient-centered health status measures and quality of life indices in evaluating the effectiveness of treatments for cardiovascular disease. These measures help assess how treatments like Mom♥Health can improve patients' symptoms, function, and overall quality of life, which are crucial outcomes in managing cardiovascular conditions. ^{1 2 3 4 5}

How is the Mom♥Health treatment different from other cardiovascular disease treatments?

Mom♥Health is unique because it focuses on the role of women, particularly mothers, in managing cardiovascular risk factors for themselves and their families, emphasizing lifestyle changes and awareness rather than just medication. This approach highlights the importance of maternal health and family involvement in preventing heart disease. ^{6 7 8 9 10}

What is the purpose of this trial?

This single-site research study will pilot-test a context-specific cardiovascular disease (CVD) risk prevention program, Mom♥Health, using two childhood centers at Family Health Centers (FHC) at NYU Langone as platforms for maternal engagement.

Research Team

Milla Arabadjian

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

A Comparative Effectiveness Review: RESPONSIVENESS OF PATIENT OUTCOME MEASURES IN CARDIAC AND PULMONARY REHABILITATION. [2020]

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

Outcomes measurement. [2019]

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

Evolving applications for patient-centered health status measures. [2008]

4. England pubmed.ncbi.nlm.nih.gov

The Role of Quality of Life Indices in Patient-Centred Management of Arrhythmia. [2021]

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

Targeted versus standard feedback: results from a randomized quality improvement trial. [2019]

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

Infant feeding in America: enough to break a mother's heart? [2013]

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

Childrearing women and their families: setting the stage for heart health. [2011]

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

Cardiovascular Considerations in Caring for Pregnant Patients: A Scientific Statement From the American Heart Association. [2021]

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

The maternal health clinic: an initiative for cardiovascular risk identification in women with pregnancy-related complications. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Impact of Medication Adherence on Mortality and Cardiovascular Morbidity: Protocol for a Population-Based Cohort Study. [2020]