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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Socially Vulnerable Mothers | Experimental | Socially 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS-10) Score | 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
Self-identifies as a woman.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Milla Arabadjian | Contact | 5166631668 | Milla.arabadjian@nyulangone.org | |
| Mark Bond | Contact | 646-754-7217 | mark.bond@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Milla Arabadjian | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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|
| Perceived Stress Scale (PSS-10) Score |
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. |
| Week 12 |
| Perceived Stress Scale (PSS-10) Score | 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. | Week 18 |
| Patient Health Questionnaire (PHQ-8) Score | 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. | Baseline |
| Patient Health Questionnaire (PHQ-8) Score | 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. | Week 12 |
| Patient Health Questionnaire (PHQ-8) Score | 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. | Week 18 |
| Mediterranean Eating Pattern for Americans (MEPA) Score | 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. | Baseline |
| Mediterranean Eating Pattern for Americans (MEPA) Score | 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. | Week 12 |
| Mediterranean Eating Pattern for Americans (MEPA) Score | 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. | Week 18 |
| International Physical Activity Questionnaire (IPAQ) Score | 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. | Baseline |
| International Physical Activity Questionnaire (IPAQ) Score | 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. | Week 12 |
| International Physical Activity Questionnaire (IPAQ) Score | 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. | Week 18 |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score | 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. | Baseline |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score | 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. | Week 12 |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score | 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. | Week 18 |
| Mean Blood Pressure | 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. | Baseline |
| Mean Blood Pressure | 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. | Week 12 |
| Mean Blood Pressure | 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. | Week 18 |