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.

项目概要 该申请提出了第二代干预措施以改善印第安纳州和印第安纳州的心血管健康 伊利诺伊州通过家访 (2-NOURISH) 是为了响应 RFA“早期干预以促进 母亲和儿童心血管健康 (ENRICH) 多站点临床中心 (RFA-HL-22-007)”。 孕产妇发病率和死亡率不断上升，优化孕产妇心血管健康的干预措施 （CVH）是迫切需要的。母亲 CVH 不良也与后代 CVH 不良相关。结果， 围产期是干预的最佳时机，但循证干预措施有限。家访 (HV) 计划是进行干预研究的理想环境，旨在改善孕产妇和 儿童 CVH，因为他们已经为美国各地的高危人群提供服务，其中穷人的患病率很高 简历。拟议的临床中心 2-NOURISH，由西北大学领导，与两家循证医学机构合作 HV 模型（美国健康家庭 [HFA] 和家长作为教师 [PAT]）以及基于证据的虚拟模型 生活方式干预平台慧俪轻体国际 (WW) 拥有唯一资格参与所有活动 ENRICH 网络的各个方面，并大幅提高网络的目标。在我们的应用程序中，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 的循证围产期抑郁症和压力管理干预措施（母亲和 婴儿）； (2) 在孕产妇和儿童 CVH 的开发和评估方面具有丰富的专业知识，特别是 围产期； (3) 在招募和保留不同人群方面拥有丰富的经验 用于行为干预。在 UG3 阶段（第 1-2 年），我们将在 ENRICH 内协作 网络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 年级），我们将与 40 个 HV 项目合作，招募 600 名母子二人组 伊利诺伊州和印第安纳州在拟议的研究时间表内实现 ENRICH 网络目标总数 3000 成对地检查准备实施、以 CVH 为重点、基于证据的干预措施的有效性。 我们仔细考虑了潜在的研究设计，并提出了混合有效性实施类型 1 采用整群随机设计的试验，该设计将在家庭访客水平上进行随机化。此外，鉴于 怀孕期间干预对孕产妇和后代的潜在益处，我们建议产前招募。 我们提出的干预措施还包括创新的产前（推广压力管理技术、 家庭访客患者导航）和产后（通过虚拟分娩平台进行强化生活方式干预， 同伴支持）组件。我们的临床中心还致力于培养早期阶段的技能 与临床试验设计相关的研究者以及与 CVH 构建相关的家访人员的技能、其 组件和通用研究方案。 2-NOURISH 非常适合作为临床中心和 为网络公平改善孕产妇和幼儿 CVH 的长期使命做出贡献。