Cardiovascular Health
Conditions
Brief summary
This project will test the feasibility, acceptability, and preliminary effects of a tailored cardiovascular (CV) health promotion program, Mom♥Health2.0, leveraging childcare centers as platforms for maternal engagement. Investigators will enroll 50 mothers from Childcare Centers in New York City.
Interventions
BEHAVIORALMom♥Health2.0
The 10 week intervention will include 1) 8 individual weekly phone calls to mothers that consist of education and counseling related to a hearth healthy lifestyle as well as strategies for stress reduction; 2) two in-person sessions to be held in the designated Childcare Centers that will focus on providing practical tips for self-care and as platform for connection among mothers; 3) referral to clinical care for identified needs (e.g., elevated blood pressure); 4) referral to available social resources (e.g., food pantry for identified food insecurity).
Sponsors
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Female adults, age 18-49 years. * Mothers, self-identified as primary caregivers of children ≤ 5 years (biological, adopted, fostered) whose child(ren) attend formal childcare (no home daycare); * English or Spanish speaking. * Willing and able to consent to participation.
Exclusion criteria
* Significant cognitive impairment (evident during screening) * Current participation in another behavioral clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Program Completion | Up to Week 10 (End of Intervention) | Feasibility is measured as the number of participants with 80% participant program completion. |
| Feasibility: Appointment Scheduling | Up to Week 18 (End of Study) | Feasibility is measured as the number of participants with 80% clinic/social services appointment scheduled for identified needs |
| Acceptability: Consent Rate | Baseline | Acceptability is measured as the consent rate of eligible mothers; the aim is 80%. |
| Acceptability: Client Satisfaction | Week 18 (End of Study) | Acceptability is measured as the number of participants with an average post-intervention Client Satisfaction Questionnaire-8 score ≥ 25. The questionnaire comprises 8-items and assesses program satisfaction in: quality, whether it has met individual needs, if the individual would recommend to others. The total range is 8-32; a score of 25 is an established cutoff for good satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Life's Essential Eight Score | Baseline, Week 18 (End of Study) | Life's Essential 8 includes the 8 components of cardiovascular health: healthy diet, participation in physical activity, avoidance of nicotine, healthy sleep, healthy weight, and healthy levels of blood lipids, blood glucose, and blood pressure. All eight components are scored on a scale of 0 to 100, which are averaged to create a composite score from 0-100. |
| Change in Perceived Stress Scale (PSS-4) Score | Baseline, Week 18 (End of Study) | 4-item questionnaire designed to measure how unpredictable, uncontrollable, and overwhelming events and situations were perceived to be over the past month. Each item is rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-16; higher scores indicate higher perceived stress. |
| Change in Patient Health Questionnaire (PHQ-8) Score | Baseline, Week 18 (End of Study) | 8-question self-assessment tool used to screen for and measure the severity of depression. Each item is rated on a Likert scale from 0-3; the total score is the sum of responses and ranges from 0-24; higher scores indicate greater severity of depression. |
Countries
United States
Contacts
CONTACTMilla Arabadjian, PhD
PRINCIPAL_INVESTIGATORMilla Arabadjian, PhD
NYU Langone Health
Outcome results
None listed