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Not yet recruiting NCT07724821

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

No phase Interventional Cardiovascular Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mom♥Health2.0.
Who it may be relevant to
Registry conditions: Cardiovascular Health. Basic parameters: 18 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Behavioral Mom♥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 r

Primary outcome measures

  • Feasibility: Program Completion [Time frame: Up to Week 10 (End of Intervention)]
  • Feasibility: Appointment Scheduling [Time frame: Up to Week 18 (End of Study)]
  • Acceptability: Consent Rate [Time frame: Baseline]
  • Acceptability: Client Satisfaction [Time frame: Week 18 (End of Study)]
Secondary outcome measures (3)
  • Change in Life's Essential Eight Score [Time frame: Baseline, Week 18 (End of Study)]
  • Change in Perceived Stress Scale (PSS-4) Score [Time frame: Baseline, Week 18 (End of Study)]
  • Change in Patient Health Questionnaire (PHQ-8) Score [Time frame: Baseline, Week 18 (End of Study)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07724821 · 26-00367 · K23HL177329-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗