MomHeartHealth: Reducing Cardiovascular Risk

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06796075
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-20
• Study Start: 2025-05-19
• Primary Completion: 2026-04
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who Schedule Clinic/Social Services Appointment for Identified Needs	Week 18	Measure of intervention feasibility; measured among participants with an identified need.
Client Satisfaction Questionnaire-8 Score	Week 18	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.
Percentage of Participants who Complete Intervention Program	Week 12	Measure of intervention feasibility.
Percentage of Eligible Mothers who Consent to Enroll	Baseline	Measure of intervention acceptability.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS-10) Score	Week 18	The PSS-10 is a 10-item assessment of the degree to which respondents feel that life was overwhelming, uncontrollable, and unpredictable over the last month. Items are rated on a 5-point scale. PSS-10 scores range from 0-40, with higher scores indicating greater perceived stress.
Patient Health Questionnaire (PHQ-8) Score	Week 18	The PHQ-8 is an 8-item measure of depressive symptoms during the prior two weeks. Each item has a response scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-24; higher scores indicate greater levels of depression.
Mediterranean Eating Pattern for Americans (MEPA) Score	Week 18	The Mediterranean Eating Pattern for Americans (MEPA) is a 16-item measure of how well a person's diet adheres to the Mediterranean diet. The MEPA score is calculated by assigning a score of 0 or 1 to each item on the MEPA screener. Scores range from 0 to 16; higher scores indicate greater adherence to the Mediterranean diet.
Mean Blood Pressure	Week 18	At each time point, 3 BP readings separated by one minute will be obtained. The 3 BP readings will be averaged to obtain the mean study BP.
International Physical Activity Questionnaire (IPAQ) Score	Week 18	The IPAQ is an assessment how much time participants spent being physically active in the last 7 days. The score is calculated expressed as metabolic equivalent of task (MET)-minutes per week. Higher scores indicate greater physical activity.
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score	Week 18	The PROMIS-Sleep Disturbance subscale is an 8-item questionnaire designed to assess an individual's perception of their sleep disturbances. Each item is rated on a scale from 1-5. The total score is the sum of responses and ranges from 8 to 40, with higher scores indicating more severe sleep disturbance.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States