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)

基本信息

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
项目类别：
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

项目摘要

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.

项目概要这项两阶段随机对照试验将检查实施情况和有效性对产后母亲和幼儿进行心血管健康（CVH）干预的研究到 3 岁。我们将把 CVH 干预纳入基于证据的家访计划，家庭检查 (FCU) 通过 1 型混合有效性创建 FCU-Heart。实施设计，第一阶段RCT试点研究将检验可行性和有效性 FCU-Heart（FCU-Heart，n=100；FCU，n=50）（目标 1a 和 1b）。研究的目的是了解 FCU-Heart 的实施范围、参与度和背景收集信息以开展第二次多中心家访模式试验。我们的研究阶段将通过以下方法将 FCU-Heart 与标准 FCU 结果进行比较：我们的 FCU-Heart 计划旨在开展协作、多中心随机试验（目标 2 和 3）。改善高风险母亲（低收入母亲在怀孕期间有心血管风险）的CVH 妊娠（高血压、糖尿病、肥胖）与传统 FCU 和其他家庭相比通过纳入个性化、具有文化能力的干预措施来访问项目饮食和运动、血压控制、压力管理和自我保健以及吸烟干预包括心血管评估和反馈，然后是戒烟。由家庭教练以 3-4 周的模块提供量身定制的治疗计划，以建立目标这些会议将致力于获得积极的 CVH 成果和通过教育和与婴儿的母亲建立联系，赋予婴儿母亲实现她们的目标的能力我们采取的资源也将保留儿童 CVH 的初步分析将评估。 FCU-Heart 对 1、2 和 3 岁儿童 CVH 结局的影响与单独的 FCU 相比，基于黑人 CVH 并发症的发生率较高。妇女和儿童，我们将研究 FCU-Heart 与单独 FCU 对孕产妇和儿童的影响儿童 CVH 在 1 年、2 年和 3 年评估中的种族差异（目标 3）。改善产后母亲和幼儿的 CVH 轨迹的潜力其发展的关键时期，提供持久的健康益处。