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NCT Number: NCT06796075

Identifying Strategies to Reduce Cardiovascular Risk Among Mothers of Young Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Diseases

Age range

21 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mom♥Health

Behavioral

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).

Primary outcomes

  1. Percentage of Participants who Complete Intervention Program

    Time frame: Week 12

    Measure of intervention feasibility.

  2. Percentage of Participants who Schedule Clinic/Social Services Appointment for Identified Needs

    Time frame: Week 18

    Measure of intervention feasibility; measured among participants with an identified need.

  3. Client Satisfaction Questionnaire-8 Score

    Time frame: 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.

  4. Percentage of Eligible Mothers who Consent to Enroll

    Time frame: Baseline

    Measure of intervention acceptability.

Secondary outcomes

  1. Perceived Stress Scale (PSS-10) Score

    Time frame: Baseline

    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.

  2. Perceived Stress Scale (PSS-10) Score

    Time frame: Week 12

    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.

  3. Perceived Stress Scale (PSS-10) Score

    Time frame: 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.

  4. Patient Health Questionnaire (PHQ-8) Score

    Time frame: Baseline

    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.

  5. Patient Health Questionnaire (PHQ-8) Score

    Time frame: Week 12

    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.

  6. Patient Health Questionnaire (PHQ-8) Score

    Time frame: 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.

  7. Mediterranean Eating Pattern for Americans (MEPA) Score

    Time frame: Baseline

    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.

  8. Mediterranean Eating Pattern for Americans (MEPA) Score

    Time frame: Week 12

    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.

  9. Mediterranean Eating Pattern for Americans (MEPA) Score

    Time frame: 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.

  10. International Physical Activity Questionnaire (IPAQ) Score

    Time frame: Baseline

    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.

  11. International Physical Activity Questionnaire (IPAQ) Score

    Time frame: Week 12

    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.

  12. International Physical Activity Questionnaire (IPAQ) Score

    Time frame: 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.

  13. Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score

    Time frame: Baseline

    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.

  14. Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score

    Time frame: Week 12

    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.

  15. Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score

    Time frame: 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.

  16. Mean Blood Pressure

    Time frame: Baseline

    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.

  17. Mean Blood Pressure

    Time frame: Week 12

    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.

  18. Mean Blood Pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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