Community Engagement for Cardiovascular Health Promotion in Mothers (MomHeartHealth2.0)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorNYU Langone Health

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Mom♥Health2.0

    Behavioral

    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).

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: MothersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: Program Completion

Feasibility is measured as the number of participants with 80% participant program completion.

Time frame
Up to Week 10 (End of Intervention)
2

Feasibility: Appointment Scheduling

Feasibility is measured as the number of participants with 80% clinic/social services appointment scheduled for identified needs

Time frame
Up to Week 18 (End of Study)
3

Acceptability: Consent Rate

Acceptability is measured as the consent rate of eligible mothers; the aim is 80%.

Time frame
Baseline
4

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.

Time frame
Week 18 (End of Study)

Secondary outcomes

1

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.

Time frame
Baseline, Week 18 (End of Study)
2

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.

Time frame
Baseline, Week 18 (End of Study)
3

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.

Time frame
Baseline, Week 18 (End of Study)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: