[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07724821":3,"trial-entities:NCT07724821":96,"trial-summary:NCT07724821":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":20,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":50,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":75,"locations":77,"central_contacts":85,"overall_officials":91,"references":94,"see_also_links":95},"NCT07724821","26-00367","Community Engagement for Cardiovascular Health Promotion in Mothers (MomHeartHealth2.0)","NOT_YET_RECRUITING","2030-08","2026-07","2026-07-24","2026-08-24","NYU Langone Health","OTHER",null,"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.",[17],"Cardiovascular Health",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[22],"NA",{"count":24,"type":25},50,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"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 resources (e.g., food pantry for identified food insecurity).",[32],"Mothers",[34,38,42,46],{"measure":35,"description":36,"timeFrame":37},"Feasibility: Program Completion","Feasibility is measured as the number of participants with 80% participant program completion.","Up to Week 10 (End of Intervention)",{"measure":39,"description":40,"timeFrame":41},"Feasibility: Appointment Scheduling","Feasibility is measured as the number of participants with 80% clinic\u002Fsocial services appointment scheduled for identified needs","Up to Week 18 (End of Study)",{"measure":43,"description":44,"timeFrame":45},"Acceptability: Consent Rate","Acceptability is measured as the consent rate of eligible mothers; the aim is 80%.","Baseline",{"measure":47,"description":48,"timeFrame":49},"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.","Week 18 (End of Study)",[51,55,58],{"measure":52,"description":53,"timeFrame":54},"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.","Baseline, Week 18 (End of Study)",{"measure":56,"description":57,"timeFrame":54},"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.",{"measure":59,"description":60,"timeFrame":54},"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.","FEMALE","18 Years","49 Years",true,{"inclusion":66,"exclusion":71,"raw_text":74},[67,68,69,70],"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.",[72,73],"Significant cognitive impairment (evident during screening)","Current participation in another behavioral clinical trial","Inclusion Criteria:\n\n* Female adults, age 18-49 years.\n* Mothers, self-identified as primary caregivers of children ≤ 5 years (biological, adopted, fostered) whose child(ren) attend formal childcare (no home daycare);\n* English or Spanish speaking.\n* Willing and able to consent to participation.\n\nExclusion Criteria:\n\n* Significant cognitive impairment (evident during screening)\n* Current participation in another behavioral clinical trial",[76],"ADULT",[78],{"facility":12,"city":79,"state":79,"zip":80,"country":81,"geoPoint":82},"New York","10016","United States",{"lat":83,"lon":84},40.71427,-74.00597,[86],{"name":87,"role":88,"phone":89,"email":90},"Milla Arabadjian, PhD","CONTACT","516-663-1668","Milla.arabadjian@nyulangone.org",[92],{"name":87,"affiliation":12,"role":93},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":98},[17],[],{"nct_id":4,"found":64,"summary":100,"prompt_version":110},{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an interventional study, meaning participants will receive a specific program. It aims to enroll 50 mothers.","completed","Mom♥Health2.0 for Cardiovascular Health in Mothers","This study is testing a program called Mom♥Health2.0 to help mothers improve their heart health. It's designed for mothers aged 18-49 who are primary caregivers of young children (5 years old or younger) attending formal childcare, and who speak English or Spanish. The Mom♥Health2.0 program involves 10 weeks of individual phone calls for education and counseling on healthy living and stress reduction, plus two in-person sessions at childcare centers. Researchers want to see if the program is practical to run (feasibility), if mothers like it (acceptability), and its early effects. They plan to enroll 50 mothers from childcare centers in New York City. The current status of this study is unclear.","Your participation will be tracked for up to 18 weeks (end of study).",111,"You would participate in a 10-week program, including 8 weekly phone calls and two in-person sessions.","Not stated in the trial record.",[29],"v2"]