2-Generation Interventions to Improve Cardiovascular Health in Indiana and Illinois Through Home Visiting (2-NOURISH)

通过家访改善印第安纳州和伊利诺伊州心血管健康的第二代干预措施 (2-NOURISH)

• 批准号: 10427796
• 负责人: Matthew M Davis
• 金额: $ 64.94万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 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/10427796
• 关键词: 3 year old; 5 year old; Address; Adoption; Advisory Committees; Age; American Heart Association; Americas; Behavior Therapy; Birth; Body mass index; Cardiovascular Diseases; Cause of Death; Child; Childhood; Clinical Trials Design; Cognitive Therapy; Collaborations; Communities; Data; Development; Early Intervention; Effectiveness; Enrollment; Ensure; Ethnic Origin; Evidence based intervention; Family; Generations; Geography; Goals; Health; Health Policy; Health Promotion; Health behavior; High Prevalence; Home; Home visitation; Illinois; Impaired cognition; Indiana; Individual; International; Intervention; Intervention Studies; Life Cycle Stages; Link; Maintenance; Maternal Mortality; Maternal and Child Health; Measures; Mental Depression; Mental Health; Mission; Modeling; Monitor; Mothers; National Heart, Lung, and Blood Institute; Network-based; Obesity; Outcome; Overweight; Parents; Participant; Patients; Perinatal; Phase; Population; Population Heterogeneity; Populations at Risk; Positioning Attribute; Postpartum Period; Pregnancy; Preventive service; Protocols documentation; Psychosocial Factor; Race; Randomized; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Research Design; Research Personnel; Resources; Risk; Science; Services; Societies; Socioeconomic Status; Techniques; Testing; Time; TimeLine; United States; Weight; Work; base; cardiovascular disorder risk; cardiovascular health; clinical center; clinically relevant; cost; design; disability; early childhood; effectiveness evaluation; effectiveness implementation study; effectiveness testing; evidence base; experience; health assessment; health disparity; health of the mother; healthy weight; implementation evaluation; implementation outcomes; implementation science; improved; in utero; innovation; intergenerational; intervention participants; lifestyle intervention; maternal morbidity; multi-component intervention; multidisciplinary; multiple chronic conditions; offspring; peer support; perinatal period; peripartum depression; pilot test; pregnant; prenatal; programs; psychosocial; recruit; response; sex; skills; stress management; success; teacher; transmission process; virtual delivery; virtual platform; young adult

PROJECT SUMMARY This application proposing the 2-GeneratioN Interventions to ImprOve CardiovascUlaR Health in Indiana and IllinoiS Through Home Visiting (2-NOURISH) is in response to the RFA “Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Clinical Center (RFA-HL-22-007)”. Given growing rates of maternal morbidity and mortality, interventions to optimize maternal cardiovascular health (CVH) are urgently needed. Poor maternal CVH is also associated with poor offspring CVH. As a result, the perinatal period is an opportune time to intervene, but evidence-based interventions are limited. Home visiting (HV) programs serve as an ideal setting to conduct intervention research aimed at improving maternal and child CVH as they already serve an at-risk population across the United States with a high prevalence of poor CVH. The proposed Clinical Center, 2-NOURISH, led by Northwestern, in partnership with two evidence-based HV models (Healthy Families America [HFA] and Parents as Teachers [PAT]), and an evidence-based virtual platform for lifestyle intervention, Weight Watchers International (WW), is uniquely qualified to participate in all aspects of the ENRICH Network and to substantially enhance the Network’s goals. In our application, we demonstrate key prior experiences, which include: (1) long-standing collaborations with HV models, including MPI Tandon’s evidence-based perinatal depression and stress management intervention (Mothers and Babies); (2) significant expertise in the development and assessment of maternal and child CVH, particularly during the perinatal period; and (3) extensive experience with recruitment and retention of diverse populations for behavior interventions. During the UG3 phase (Years 1-2), we will work collaboratively within the ENRICH Network to develop a common study protocol, adapt the intervention content, and conduct pilot tests. During the UH3 phase (Years 3-7), we will recruit 600 mother-child dyads in partnership with 40 HV programs in Illinois and Indiana within the proposed study timeline to achieve the ENRICH Network Goal of 3000 total dyads to examine the effectiveness of an implementation-ready, CVH-focused, evidence-based intervention. We carefully considered potential study designs and propose a Hybrid Effectiveness-Implementation Type 1 trial with a cluster randomized design that would randomize at the home visitor-level. Additionally, given the potential maternal and offspring benefits of intervention during pregnancy, we propose prenatal recruitment. Our proposed intervention also includes innovative prenatal (promotion of stress management techniques, home visitor patient navigation) and postpartum (intensive lifestyle intervention with a virtual delivery platform, peer support) components. Our Clinical Center is additionally committed to developing the skills of Early Stage Investigators related to clinical trial design and the skills of home visitors related to the construct of CVH, its components, and the common study protocol. 2-NOURISH is ideally suited to serve as a Clinical Center and contribute to the Network’s long-term mission to equitably improve maternal and early childhood CVH.

项目摘要 该申请提出了2代干预措施，以改善印第安纳州和 伊利诺伊州通过家庭访问（2-nourish）回应RFA“早期干预以促进 母亲和儿童的心血管健康（富集）多站点临床中心（RFA-HL-22-007）。 孕产妇发病率和死亡率的增长，干预措施以优化母体心血管健康 （CVH）迫切需要。较差的母校CVH也与后代CVH差有关。结果， 围产期是干预的机会时间，但基于证据的干预措施有限。家参观 （HV）计划是进行干预研究的理想场所，旨在改善母校和 儿童CVH由于已经为美国的高风险人口服务而贫穷的流行率很高 CVH。拟议的临床中心（2个）由西北地区领导，与两个基于证据的 HV模型（美国健康家庭[HFA]和父母作为老师[PAT]）和循证虚拟 生活方式干预平台，体重观察者国际（WW）具有独特的资格参加所有人 丰富网络的各个方面并大大提高了网络的目标。在我们的应用中，我们 展示关键的先前经验，其中包括：（1）与HV模型的长期合作，包括 MPI Tandon的基于证据的围产期抑郁和压力管理干预措施（母亲和 婴儿）； （2）在孕产妇和儿童CVH的开发和评估方面的重要专家，特别是 在围产期； （3）在招聘和保留潜水员人群方面的丰富经验 用于行为干预措施。在UG3阶段（1-2年）期间，我们将在丰富的内部合作工作 网络以制定共同的研究方案，调整干预内容并进行试点测试。期间 UH3阶段（3 - 7年），我们将与40个HV计划合作招募600个母子二元组 伊利诺伊州和印第安纳州在拟议的研究时间表中实现3000个全网络目标 二元组研究准备就绪的实施，以CVH为基础的，基于证据的干预措施。 我们仔细考虑了潜在的研究设计和提案，一种混合​​有效性 - 实施1型 试用群集随机设计，该设计将随机在家庭访问者级别上随机进行试验。另外，给定 我们提出了产前招募，在怀孕期间干预的潜在材料和后代益处。 我们提出的干预措施还包括创新的产前（促进压力管理技术， 家庭访客患者导航）和产后（使用虚拟递送平台进行密集的生活方式干预， 同行支持）组件。我们的临床中心还致力于发展早期的技能 与临床试验设计和与CVH结构相关的家庭访客的技能有关的研究人员 组件和共同的研究方案。 2-nourish理想地适合作为临床中心和 促进该网络的长期任务，以同样改善孕产妇和幼儿CVH。