Identifying Strategies to Reduce Cardiovascular Risk Among Mothers of Young Children
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Jul 2025
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
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 28, 2025
CompletedStudy Start
First participant enrolled
July 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 5, 2026
March 1, 2026
1.1 years
January 22, 2025
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of Participants who Complete Intervention Program
Measure of intervention feasibility.
Week 12
Percentage of Participants who Schedule Clinic/Social Services Appointment for Identified Needs
Measure of intervention feasibility; measured among participants with an identified need.
Week 18
Client Satisfaction Questionnaire-8 Score
8-item questionnaire related to satisfaction with intervention/service experience. Each item is rated on a Likert scale from 1-4; the total score is the sum of responses and ranges from 8 to 32, with the higher number indicating greater satisfaction.
Week 18
Percentage of Eligible Mothers who Consent to Enroll
Measure of intervention acceptability.
Baseline
Secondary Outcomes (18)
Perceived Stress Scale (PSS-10) Score
Baseline
Perceived Stress Scale (PSS-10) Score
Week 12
Perceived Stress Scale (PSS-10) Score
Week 18
Patient Health Questionnaire (PHQ-8) Score
Baseline
Patient Health Questionnaire (PHQ-8) Score
Week 12
- +13 more secondary outcomes
Study Arms (1)
Socially Vulnerable Mothers
EXPERIMENTALSocially 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.
Interventions
12-week intervention involving 1) weekly phone calls to mothers regarding education and counseling related to heart healthy lifestyle, as well as strategies for stress reduction; 2) referral to clinical care for identified needs (e.g., elevated blood pressure); and 3) referral to available social resources (e.g., food pantry for identified food insecurity).
Eligibility Criteria
You may qualify if:
- Self-identifies as a woman
- Is a primary caregiver of child(ren) ≤ 5 years (biological, adopted, fostered) and the child(ren) attends one of the designated childhood centers at FHC at NYU Langone;
- Is between 21-49 years of age
- Is English/Spanish/Mandarin speaking
- Has the capacity and willingness to provide consent
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
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Milla Arabadjian
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2025
First Posted
January 28, 2025
Study Start
July 11, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 5, 2026
Record last verified: 2026-03
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
- The investigator who proposed to use the data will be granted access upon reasonable request. 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 requesting investigator 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.