Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children (ENRICH)

扩大幼儿期家庭检查，促进母婴心血管健康 (ENRICH)

• 批准号: 10427592
• 负责人: Janet M Catov
• 金额: $ 63.11万
• 依托单位: MAGEE-WOMEN'S RES INST AND FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-16 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10427592
• 关键词: 3 year old; Address; Adherence; Adolescent; Age; Area; Biological; Black race; Blood Pressure; Body mass index; Breast Feeding; Cardiac health; Cardiovascular Diseases; Cardiovascular system; Caring; Child; Child Behavior; Child Health; Child Rearing; Childhood; Cholesterol; Cities; Color; Communities; Coupled; Credentialing; Data; Development; Diabetes Mellitus; Diet; Education; Effectiveness; Family; Feedback; Gestational Diabetes; Glucose; Goals; Growth; Health; Health Benefit; Health Promotion; Health behavior; Health education; Healthcare; Heart; Home Blood Pressure Monitoring; Home visitation; Hybrids; Hypertension; Infant; Intervention; Life Style; Low income; Maintenance; Maternal Mortality; Mental Depression; Mental Health; Modeling; Mothers; National Heart, Lung, and Blood Institute; Neighborhoods; Obesity; Outcome; Parents; Personal Satisfaction; Phase; Physical activity; Pilot Projects; Postpartum Period; Pregnancy; Provider; Randomized Clinical Trials; Randomized Controlled Trials; Research; Resources; Risk; School-Age Population; Self Care; Site; Sleep; Smoking; Social support; Special Supplemental Nutrition Program for Women, Infants, and Children; Testing; Training; Trust; Weight; Weight Gain; Work; Youth; antisocial behavior; base; behavioral health; black women; blood pressure control; cardiovascular disorder risk; cardiovascular health; cardiovascular risk factor; checkup examination; critical period; cultural competence; diet and exercise; digital; early childhood; effectiveness implementation design; effectiveness implementation study; effectiveness testing; empowered; evidence base; feasibility testing; flexibility; follow-up; health care availability; health disparity; health of the mother; high risk; implementation context; improved; individualized medicine; innovation; lower income families; maternal depression; maternal morbidity; metropolitan; mortality; multi-site trial; novel; nutrition; pilot trial; pregnancy disorder; pregnancy hypertension; premature; prenatal; preservation; programs; racial disparity; racial health disparity; randomized trial; remote intervention; severe maternal morbidity; skills; smoking cessation; social; social health determinants; stress management; substance use; suicidal risk; treatment effect; treatment program; treatment response; trend

Project Summary This two-phased randomized controlled trial will examine the implementation and effectiveness of a cardiovascular health (CVH) intervention on postpartum mothers and young children through age 3. We will adapt a CVH intervention into an evidence-based home visiting program, Family Check-Up (FCU) to create FCU-Heart. Through a Type 1 hybrid effectiveness- implementation design, the first phase RCT pilot study will test the feasibility and effectiveness of FCU-Heart (FCU-Heart, n=100; FCU, n=50) (Aim 1a and 1b). A second goal of the hybrid study is to understand the reach, engagement, and context for implementation of FCU-Heart and gather information for development of the multi-center home visiting model trial. The second phase of our study will compare the FCU-Heart to standard FCU outcomes through a collaborative, multicenter randomized trial (Aims 2 and 3). Our FCU-Heart program is intended to improve the CVH of high-risk mothers (low-income with cardiovascular risk during pregnancy—hypertension, diabetes, obesity) compared to the traditional FCU and other home visiting programs by incorporating individualized, culturally competent interventions that target diet and exercise, blood pressure control, stress management and self-care, and smoking cessation. The intervention includes cardiovascular assessment and feedback, followed by a tailored treatment program delivered by family coaches in 3-4 week modules to establish goals and track progress. These sessions will work towards obtaining positive CVH outcomes and empowering mothers of infants to achieve their goals through education and a connection to resources which we hypothesize will also preserve child CVH. Primary analyses will assess the impact of FCU-Heart on maternal and child CVH outcomes at child ages 1, 2, and 3 years compared to FCU Alone. Further, based on the higher rates of CVH complications among Black women and children, we will examine the effects of FCU-Heart vs FCU alone on maternal and child CVH racial disparities at the 1-, 2-, and 3-year assessments (Aim 3). This application has the potential to improve the CVH trajectories of postpartum mothers and young children during a critical period of their development, providing long-lasting health benefits.

项目摘要 这两个阶段的随机对照试验将检查的实施和有效性 产后母亲和幼儿的心血管健康（CVH）干预 直到3岁。我们将把CVH干预调整为基于证据的家访计划， 家庭检查（FCU），以创建FCU心脏。通过1型混合效率- 实施设计，第一阶段RCT试点研究将测试可行性和有效性 FCU-心脏（FCU-心脏，n=100; FCU，n=50）（目标1a和1b）。混合动力车的第二个目标 研究的目的是了解FCU-Heart实施的范围、参与度和背景 并为多中心家访模式试验的发展收集信息。第二 我们研究的第一阶段将通过一个 合作，多中心随机试验（目的2和3）。我们的FCU心脏计划旨在 改善高风险母亲的CVH（低收入， 妊娠高血压，糖尿病，肥胖）相比，传统的FCU和其他家庭 访问计划，包括个性化的，文化上有能力的干预措施， 饮食和锻炼，血压控制，压力管理和自我护理，以及吸烟 停止干预包括心血管评估和反馈，然后是 由家庭教练在3-4周的模块中提供量身定制的治疗方案，以建立目标 并跟踪进度。这些会议将努力取得积极的CVH成果， 赋予婴儿母亲权力，通过教育和与 我们假设这些资源也会保护儿童CVH。主要分析将评估 FCU-心脏对1岁、2岁和3岁儿童母亲和儿童CVH结局的影响 与单独的FCU相比。此外，基于黑人中CVH并发症的发生率较高， 我们将研究FCU-心脏与单独FCU对孕产妇和儿童的影响， 在1年、2年和3年评估时儿童CVH种族差异（目标3）。此应用程序有 改善产后母亲和幼儿CVH轨迹的潜力， 在其发展的关键时期，提供持久的健康益处。