Cardiovascular Diseases
Conditions
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.
Interventions
BEHAVIORALMom♥Health
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).
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who Complete Intervention Program | Week 12 | Measure of intervention feasibility. |
| 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 Eligible Mothers who Consent to Enroll | Baseline | Measure of intervention acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS-10) Score | 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. |
| Patient Health Questionnaire (PHQ-8) Score | 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. |
| Mediterranean Eating Pattern for Americans (MEPA) Score | 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. |
| International Physical Activity Questionnaire (IPAQ) Score | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score | 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. |
| Mean Blood Pressure | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMilla Arabadjian
NYU Langone Health
Outcome results
None listed