Community Engagement for Cardiovascular Health Promotion in Mothers (MomHeartHealth2.0)
2 other identifiers
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
July 24, 2026
CompletedStudy Start
First participant enrolled
August 24, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
Study Completion
Last participant's last visit for all outcomes
August 1, 2030
July 24, 2026
July 1, 2026
2.9 years
July 21, 2026
July 21, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Feasibility: Program Completion
Feasibility is measured as the number of participants with 80% participant program completion.
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
Up to Week 18 (End of Study)
Acceptability: Consent Rate
Acceptability is measured as the consent rate of eligible mothers; the aim is 80%.
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.
Week 18 (End of Study)
Secondary Outcomes (3)
Change in Life's Essential Eight Score
Baseline, Week 18 (End of Study)
Change in Perceived Stress Scale (PSS-4) Score
Baseline, Week 18 (End of Study)
Change in Patient Health Questionnaire (PHQ-8) Score
Baseline, Week 18 (End of Study)
Study Arms (1)
Mothers
EXPERIMENTALMothers will receive the Mom♥Health2.0 intervention, which consists of evidence-based lifestyle counseling and community-to-clinic/social services linkage.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Significant cognitive impairment (evident during screening)
- Current participation in another behavioral clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Milla Arabadjian, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2026
First Posted
July 24, 2026
Study Start (Estimated)
August 24, 2026
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
August 1, 2030
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Requests should be directed to Milla.arabadjian@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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.