About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Significant cognitive impairment (evident during screening)
Current participation in another behavioral clinical trial
Trial design
Single group
Treatments tested in this trial
Mom♥Health2.0
BehavioralThe 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).
Treatment groups
Trial outcomes
Primary outcomes
Feasibility: Program Completion
Feasibility is measured as the number of participants with 80% participant program completion.
Feasibility: Appointment Scheduling
Feasibility is measured as the number of participants with 80% clinic/social services appointment scheduled for identified needs
Acceptability: Consent Rate
Acceptability is measured as the consent rate of eligible mothers; the aim is 80%.
Acceptability: Client Satisfaction
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 outcomes
Change in Life's Essential Eight Score
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
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
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.
Sponsors and contacts
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NYU Langone Health
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: