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NCT Number: NCT07724821

Community Engagement for Cardiovascular Health Promotion in Mothers (MomHeartHealth2.0)

This project will test the feasibility, acceptability, and preliminary effects of a tailored cardiovascular (CV) health promotion program, Mom♥Health2.0, leveraging childcare centers as platforms for maternal engagement. Investigators will enroll 50 mothers from Childcare Centers in New York City.

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Key information

Conditions

Cardiovascular Health

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female adults, age 18-49 years.
  • Mothers, self-identified as primary caregivers of children ≤ 5 years (biological, adopted, fostered) whose child(ren) attend formal childcare (no home daycare);
  • English or Spanish speaking.
  • Willing and able to consent to participation.

Exclusion criteria

  • Significant cognitive impairment (evident during screening)
  • Current participation in another behavioral clinical trial

Treatment and study plan

Mom♥Health2.0

Behavioral

The 10 week intervention will include 1) 8 individual weekly phone calls to mothers that consist of education and counseling related to a hearth healthy lifestyle as well as strategies for stress reduction; 2) two in-person sessions to be held in the designated Childcare Centers that will focus on providing practical tips for self-care and as platform for connection among mothers; 3) referral to clinical care for identified needs (e.g., elevated blood pressure); 4) referral to available social resources (e.g., food pantry for identified food insecurity).

Primary outcomes

  1. Feasibility: Program Completion

    Time frame: Up to Week 10 (End of Intervention)

    Feasibility is measured as the number of participants with 80% participant program completion.

  2. Feasibility: Appointment Scheduling

    Time frame: Up to Week 18 (End of Study)

    Feasibility is measured as the number of participants with 80% clinic/social services appointment scheduled for identified needs

  3. Acceptability: Consent Rate

    Time frame: Baseline

    Acceptability is measured as the consent rate of eligible mothers; the aim is 80%.

  4. Acceptability: Client Satisfaction

    Time frame: Week 18 (End of Study)

    Acceptability is measured as the number of participants with an average post-intervention Client Satisfaction Questionnaire-8 score ≥ 25. The questionnaire comprises 8-items and assesses program satisfaction in: quality, whether it has met individual needs, if the individual would recommend to others. The total range is 8-32; a score of 25 is an established cutoff for good satisfaction.

Secondary outcomes

  1. Change in Life's Essential Eight Score

    Time frame: Baseline, Week 18 (End of Study)

    Life's Essential 8 includes the 8 components of cardiovascular health: healthy diet, participation in physical activity, avoidance of nicotine, healthy sleep, healthy weight, and healthy levels of blood lipids, blood glucose, and blood pressure. All eight components are scored on a scale of 0 to 100, which are averaged to create a composite score from 0-100.

  2. Change in Perceived Stress Scale (PSS-4) Score

    Time frame: Baseline, Week 18 (End of Study)

    4-item questionnaire designed to measure how unpredictable, uncontrollable, and overwhelming events and situations were perceived to be over the past month. Each item is rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-16; higher scores indicate higher perceived stress.

  3. Change in Patient Health Questionnaire (PHQ-8) Score

    Time frame: Baseline, Week 18 (End of Study)

    8-question self-assessment tool used to screen for and measure the severity of depression. Each item is rated on a Likert scale from 0-3; the total score is the sum of responses and ranges from 0-24; higher scores indicate greater severity of depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Milla Arabadjian, PhD

CONTACT

[email protected]

516-663-1668

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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