Early Intervention to Promote Cardiovascular Health of Mothers and Children in Northern Appalachia

早期干预促进阿巴拉契亚北部母亲和儿童的心血管健康

• 批准号: 10426872
• 负责人: RICHARD S. LEGRO
• 金额: $ 66.36万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-05 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10426872
• 关键词: 2 year old; 3 year old; Address; Affect; American Heart Association; Appalachian Region; Area; Behavior; Behavior Therapy; Behavioral; Birth; Body mass index; Caring; Categories; Child; Child Health; Child Rearing; Childbirth; Childhood; Client; Cluster randomized trial; Communities; Computerized Medical Record; County; Documentation; Early Intervention; Economically Deprived Population; Educational Curriculum; Effectiveness; Effectiveness of Interventions; Enrollment; Family; Family Nursing; Goals; Growth; Habits; Health; Health Care Sector; Health Personnel; Health Services Accessibility; Health system; Healthcare; Heart Diseases; Home; Home environment; Home visitation; Household; Infant; Infant Care; Informal Social Control; Interruption; Intervention; Intervention Studies; Knowledge; Lead; Life; Life Style; Link; Manuals; Maternal and Child Health; Measures; Metabolic syndrome; Minority Groups; Modeling; Mothers; Multi-Institutional Clinical Trial; Multicenter Trials; National Heart, Lung, and Blood Institute; Nurses; Nutritional; Nutritionist; Obesity; Outcome; Participant; Patient Recruitments; Phase; Positioning Attribute; Postpartum Period; Poverty; Pregnancy; Pregnant Women; Primary Health Care; Primary Prevention; Protocols documentation; Randomized; Research; Research Design; Risk; Risk Factors; Schedule; Self Efficacy; Site; Sleep; Testing; Tobacco use; Training; Treatment Efficacy; Visit; Vulnerable Populations; Weight; Woman; Work; base; cardiovascular health; caregiving; cigarette smoking; comorbidity; data sharing; design; disparity reduction; early childhood; effectiveness testing; efficacious intervention; experience; food security; health equity; health information technology; health of the mother; healthy lifestyle; high risk; hybrid type 1 trial; implementation context; improved; improved outcome; indexing; infancy; lifestyle intervention; medically underserved; meetings; member; mortality; multidisciplinary; obesity prevention; obstetric care; operation; pilot test; pregnancy related death; prenatal; primary outcome; programs; psychosocial; role model; rural setting; skills; social cognitive theory; social health determinants; therapy design; tobacco exposure; tv watching; underserved area; urban setting

PROJECT SUMMARY/ABSTRACT As part of NHLBI’s ENRICH program, this research will test an implementation-ready intervention designed to improve cardiovascular health (CVH) among high risk mothers and young children during pregnancy and the first two years after delivery. Home visitation (HV) models meeting federal criteria of evidence of effectiveness will be leveraged to compare existing HV programs against those with an additional CVH intervention in a cluster-randomized, multicenter trial. Our multidisciplinary team has pioneered behavioral and lifestyle interventions for women during preconception and pregnancy and for infants during the first years after birth including those using HV for the primary prevention of obesity. We also have extensive research experience linking and integrating community- based healthcare programs with health system electronic medical records (EMRs). For this proposal, we will collaborate with two Nurse-Family Partnership agencies in Northern Appalachia, a medically underserved region with high rates of poverty and poor CVH, including high rates of obesity, heart disease, and tobacco use. We will enroll ≥500 of the 3000 pregnant women required for the UH3 phase multicenter trial. During the UG3 phase, we will pilot our proposed intervention with our community partners and work collaboratively with other ENRICH sites and NHLBI to develop the UH3 phase common protocol. Our proposed intervention incorporates tenets of Social Cognitive Theory and the Framework for Understanding Poverty using a skill-building curriculum that includes role modeling, goal-setting, and skill practice opportunities in the home. Five intervention pillars (Lifestyle Behaviors, Self-Regulation, Responsive Parenting, Home Environment, EMR Integration) are designed to increase maternal knowledge and self-efficacy in their ability to establish healthy lifestyle habits and maternal parenting practices to improve CVH. Consistent with a Hybrid Trial Type 1, the study design aims to understand the context for implementing the intervention. The composite primary outcome for mothers will be a modified version of the American Heart Association’s Life’s Simple 7 one year after childbirth; outcomes will also be assessed 2 years postpartum. The childhood primary outcome will be a composite of seven early life risk factors for poor CVH across with the final assessment at age 2 years. For these outcomes, the moderating effects of social determinants of health and psychosocial indices on outcomes will be explored. In addition, the context for implementation will be evaluated and factors influencing intervention efficacy will be identified to determine in HV, what works best, for whom, in which contexts, why and how. Lastly, we aim to lead network efforts to link and integrate HV summaries into EMRs to allow for data sharing with healthcare providers to enhance intervention effectiveness so that the UH3 protocol can evaluate whether EMR integration with HV programs improves CVH composite indicators as well as health equity.

项目摘要/摘要 作为NHLBI丰富计划的一部分，这项研究将测试设计的实施干预措施 在怀孕期间，高风险母亲和幼儿中的高风险母亲和 交货后的头两年。家庭访问（HV）模型符合联邦有效性证据的标准 将利用将现有的HV计划与在A中进行额外干预的人进行比较 集群随机，多中心试验。 在 出生后的头几年，先入为主和怀孕以及婴儿，包括使用HV 主要预防肥胖。我们还拥有广泛的研究经验，可以联系和整合社区 - 具有卫生系统电子病历（EMRS）的基于医疗保健计划。对于这个建议，我们将 与阿巴拉契亚北部的两个护士家庭合作伙伴机构合作，这是一个医疗服务不足的 贫困率高和CVH较差的地区，包括肥胖，心脏病和烟草的高率 使用。在UH3期多中心试验所需的3000名孕妇中，我们将注册≥500。 在UG3阶段，我们将与社区合作伙伴进行拟议的干预措施 与其他丰富网站和NHLBI合作，开发UH3阶段共同协议。我们提出的 干预纳入了社会认知理论的原则和理解贫困的框架 使用技能建设课程，其中包括榜样，目标设定和技能练习机会 家。五个干预支柱（生活方式行为，自我调节，响应式育儿，家庭 环境，EMR集成）旨在提高其能力的物物知识和自我效能感 建立健康的生活方式习惯和母性育儿习惯以改善CVH。与混合动力车一致 试验类型1，研究设计旨在了解实施干预的背景。复合材料 母亲的主要结果将是美国心脏协会一生的简单7的修改版本 分娩后的一年；结果也将在产后2年进行评估。童年的主要结果将 在2岁时的最终评估中，CVH差的七个早期生命危险因素的综合。 对于这些结果，健康和社会心理指数的社会决定者对 结果将被探讨。此外，将评估实施的背景和影响因素 将确定干预效率以在HV中确定最佳作用，在哪些环境中为谁，为什么 以及如何。最后，我们旨在领导网络努力，将HV摘要链接到EMR，以获取数据 与医疗保健提供者共享以提高干预效率，以便UH3协议可以评估 EMR与HV计划的集成是否可以改善CVH综合指标以及健康公平。