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临床试验/NCT06796075
NCT06796075进行中(未招募)不适用

Identifying Strategies to Reduce Cardiovascular Risk Among Mothers of Young Children

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2025年7月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
8
试验地点
2
主要终点
Percentage of Eligible Mothers who Consent to Enroll

研究概览

简要总结

This single-site research study will pilot-test a context-specific cardiovascular disease (CVD) risk prevention program, Mom♥Health, using two childhood centers at Family Health Centers (FHC) at NYU Langone as platforms for maternal engagement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Self-identifies as a woman
  • •Is a primary caregiver of child(ren) ≤ 5 years (biological, adopted, fostered) and the child(ren) attends one of the designated childhood centers at FHC at NYU Langone;
  • •Is between 21-49 years of age
  • •Is English/Spanish/Mandarin speaking
  • •Has the capacity and willingness to provide consent

排除标准

  • •Significant cognitive impairment (evident during screening)
  • •Current participation in another behavioral clinical trial

研究组 & 干预措施

Socially Vulnerable Mothers

Experimental

Socially vulnerable mothers of young children, whose children attend formal childcare, will receive telephone-delivered programs over 12 weeks. They will also attend a 6 weeks post-intervention follow-up assessment.

干预措施: Mom♥Health (Behavioral)

结局指标

主要结局

Percentage of Eligible Mothers who Consent to Enroll

时间窗: Baseline

Measure of intervention acceptability.

Percentage of Participants who Schedule Clinic/Social Services Appointment for Identified Needs

时间窗: Week 18

Measure of intervention feasibility; measured among participants with an identified need.

Percentage of Participants who Complete Intervention Program

时间窗: Week 12

Measure of intervention feasibility.

Client Satisfaction Questionnaire-8 Score

时间窗: Week 18

8-item questionnaire related to satisfaction with intervention/service experience. Each item is rated on a Likert scale from 1-4; the total score is the sum of responses and ranges from 8 to 32, with the higher number indicating greater satisfaction.

次要结局

  • Mean Blood Pressure(Week 18)
  • Perceived Stress Scale (PSS-10) Score(Baseline)
  • Perceived Stress Scale (PSS-10) Score(Week 12)
  • Patient Health Questionnaire (PHQ-8) Score(Baseline)
  • Patient Health Questionnaire (PHQ-8) Score(Week 12)
  • Mediterranean Eating Pattern for Americans (MEPA) Score(Baseline)
  • Mediterranean Eating Pattern for Americans (MEPA) Score(Week 12)
  • International Physical Activity Questionnaire (IPAQ) Score(Baseline)
  • International Physical Activity Questionnaire (IPAQ) Score(Week 12)
  • Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score(Baseline)
  • Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score(Week 12)
  • Mean Blood Pressure(Baseline)
  • Mean Blood Pressure(Week 12)
  • Perceived Stress Scale (PSS-10) Score(Week 18)
  • Patient Health Questionnaire (PHQ-8) Score(Week 18)
  • Mediterranean Eating Pattern for Americans (MEPA) Score(Week 18)
  • International Physical Activity Questionnaire (IPAQ) Score(Week 18)
  • Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance 8a Score(Week 18)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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