Cardiovascular HealthNCT07724821
Community Engagement for Cardiovascular Health Promotion in Mothers (MomHeartHealth2.0)
A study testing Mom♥Health2.0 in people with Cardiovascular Health, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Mom♥Health2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2026to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Significant cognitive impairment (evident during screening)
- Current participation in another behavioral clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Cardiovascular Health
- Being tested
- Mom♥Health2.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mom♥Health2.0Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Mothers | Experimental | Mothers will receive the Mom♥Health2.0 intervention, which consists of evidence-based lifestyle counseling and community-to-clinic/social services linkage. Receives: Behavioral: Mom♥Health2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Program Completion
Feasibility is measured as the number of participants with 80% participant program completion.
Measured: Up to Week 10 (End of Intervention)
Feasibility: Appointment Scheduling
Feasibility is measured as the number of participants with 80% clinic/social services appointment scheduled for identified needs
Measured: Up to Week 18 (End of Study)
Acceptability: Consent Rate
Acceptability is measured as the consent rate of eligible mothers; the aim is 80%.
Measured: Baseline
Acceptability: Client Satisfaction
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.
Measured: Week 18 (End of Study)
Secondary outcomes (3)
Change in Life's Essential Eight Score
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.
Measured: Baseline, Week 18 (End of Study)
Change in Perceived Stress Scale (PSS-4) Score
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.
Measured: Baseline, Week 18 (End of Study)
Change in Patient Health Questionnaire (PHQ-8) Score
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.
Measured: Baseline, Week 18 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start24 Aug 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Milla Arabadjian, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724821
- Sponsor's protocol ID
- 26-00367
- Other IDs
- K23HL177329-01A1
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the researcher who provides a methodologically sound proposal executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Milla.arabadjian@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Engagement for Cardiovascular Health Promotion in Mothers (MomHeartHealth2.0)
- ClinicalTrials.gov ID
- NCT07724821
- Acronym / sponsor ID
- 26-00367
- Conditions
- Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mothers | Experimental | Behavioral: Mom♥Health2.0Mothers will receive the Mom♥Health2.0 intervention, which consists of evidence-based lifestyle counseling and community-to-clinic/social services linkage. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Significant cognitive impairment (evident during screening)
- Current participation in another behavioral clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mom♥Health2.0The 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). | Behavioural | Mothers |
Primary outcome
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.
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
Acceptability: Consent Rate
Time frame: Baseline
Acceptability is measured as the consent rate of eligible mothers; the aim is 80%.
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.
3 secondary outcomes
Change in Life's Essential Eight Score
Time frame: Baseline, Week 18 (End of Study)
Change in Perceived Stress Scale (PSS-4) Score
Time frame: Baseline, Week 18 (End of Study)
Change in Patient Health Questionnaire (PHQ-8) Score
Time frame: Baseline, Week 18 (End of Study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the researcher who provides a methodologically sound proposal executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Milla.arabadjian@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Milla Arabadjian, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mom♥Health2.0 in people with Cardiovascular Health, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milla Arabadjian, PhD (516-663-1668, Milla.arabadjian@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Program Completion (time frame: Up to Week 10 (End of Intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.