Clinical trial NCT06796075: MomHeartHealth: Reducing Cardiovascular Risk
Official title: Community Engaged Strategies to Reduce Cardiovascular Risk Among Socially Vulnerable Mothers With Young Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants who Complete Intervention Program
timeFrame: Week 12
measure: Percentage of Participants who Schedule Clinic/Social Services Appointment for Identified Needs
timeFrame: Week 18
measure: Client Satisfaction Questionnaire-8 Score
timeFrame: Week 18
measure: Percentage of Eligible Mothers who Consent to Enroll
timeFrame: Baseline
Secondary outcomes:
measure: Perceived Stress Scale (PSS-10) Score
timeFrame: Baseline
measure: Perceived Stress Scale (PSS-10) Score
timeFrame: Week 12
measure: Perceived Stress Scale (PSS-10) Score
timeFrame: Week 18
measure: Patient Health Questionnaire (PHQ-8) Score
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-8) Score
timeFrame: Week 12
measure: Patient Health Questionnaire (PHQ-8) Score
timeFrame: Week 18
measure: Mediterranean Eating Pattern for Americans (MEPA) Score
timeFrame: Baseline
measure: Mediterranean Eating Pattern for Americans (MEPA) Score
timeFrame: Week 12
measure: Mediterranean Eating Pattern for Americans (MEPA) Score
timeFrame: Week 18
measure: International Physical Activity Questionnaire (IPAQ) Score
timeFrame: Baseline
measure: International Physical Activity Questionnaire (IPAQ) Score
timeFrame: Week 12
measure: International Physical Activity Questionnaire (IPAQ) Score
timeFrame: Week 18
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score
timeFrame: Baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score
timeFrame: Week 12
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score
timeFrame: Week 18
measure: Mean Blood Pressure
timeFrame: Baseline
measure: Mean Blood Pressure
timeFrame: Week 12
measure: Mean Blood Pressure
timeFrame: Week 18
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Milla Arabadjian
role: PRINCIPAL_INVESTIGATOR
References: