Healthy Hearts/ Corazones Saludables: Partnership to promote cardiovascular health in Hispanic and non-Hispanic mothers and children in US home visiting programs

项目概要/摘要 心血管疾病（CVD）是美国女性死亡的主要原因，约占 每三名女性死亡。肥胖可以说是预防心血管疾病干预的最强可改变目标 并与几乎所有其他主要的心血管疾病风险因素有关，包括高血压、血糖升高、高血压、高 胆固醇、不良饮食和缺乏运动。肥胖母亲的婴儿也有增加的风险， 未来的肥胖和心血管疾病。我们的团队已经开发出一种经过经验验证的生活方式干预， 在西班牙裔和非西班牙裔患者中， 妇女和儿童在怀孕期间和产后。现在必须研究如何传播这一点， 经过验证的程序。基于证据的家访计划（EBHV），支持来自 产前期到婴儿期和幼儿期是促进CVH理想环境，然而这些 这些项目的设计没有明确关注肥胖和其他心血管疾病风险因素的预防。的 拟议的研究将测试我们的产前和产后生活方式干预的有效性， 以促进母婴CVH。在最初的2年UG 3阶段，我们将：1）修改我们的预- 和产后干预，重点是EBHV内的CVH; 2）与我们的EBHV合作伙伴合作，整合CVH 信息和发展他们的相关技能; 3）加强医疗保健提供者和EBHV之间的伙伴关系 提高转诊率、保留率和改善CVH，以及4）促进高影响力研究的发展 后续UH 3阶段的设计涉及多队列方案、协调干预措施、措施 和资源对于随后的UH 3阶段，我们提出了一个混合1型有效性实施试验 我们招募了550名围产期妇女，她们将随机接受单纯EBHV或EBHV增强治疗， 通过我们的生活方式干预来促进CVH。我们的主要假设是，平均36个月， EBHV+CVH（与单独EBHV相比）将导致更有利的母亲和儿童水平的生活简单7 指标我们还将研究关键的干预调节因素，重点关注健康的社会决定因素， 调解人，包括家庭环境的变化，社会支持，CVH行为和程序 坚持。使用RE-AIM框架，我们将确定覆盖范围、有效性、采用率、实施情况， 和EBHV+CVH相对于单独EBHV的维持。其他目标是授权和减少职业倦怠， 家访;发展早期调查人员的技能，并提出创新的辅助研究，以提高 科学贡献。我们的团队在这项研究中处于非常有利的地位， 具有数十年从事NIH资助研究经验的研究人员， 研究者和来自中加州和罗得岛的EBHV站点。

Project Summary/Abstract Cardiovascular disease (CVD) is the leading cause of death in US women, accounting for approximately one of every three female deaths. Obesity is arguably the strongest modifiable target for interventions to prevent CVD and is linked with nearly every other major CVD risk factor, including hypertension, elevated glucose, high cholesterol, poor diet, and physical inactivity. Infants of mothers with obesity are also at increased risk for future obesity and CVD. Our team has developed an empirically validated lifestyle intervention that is remotely delivered and highly successful in reducing body weight and improving CVH in Hispanic and non-Hispanic women and children during pregnancy and postpartum. It is now critical to study ways to disseminate this empirically-validated program. Evidence based home visiting programs (EBHV), which support families from the prenatal period through infancy and early childhood, are an ideal setting to promote CVH, however these programs were not designed with an explicit focus on the prevention of obesity and other CVD risk factors. The proposed research will test the effectiveness of our pre- and postnatal lifestyle intervention as an enhancement to EBHV to promote maternal and child CVH. During an initial 2-year UG3 phase, we will: 1) modify our pre- and postnatal intervention to focus on CVH within EBHV; 2) Work with our EBHV partners to integrate CVH messages and develop their related skills; 3) Strengthen partnerships between healthcare providers and EBHV to increase referrals, retention, and improve CVH, and 4) Contribute to the development of a high-impact study design for the subsequent UH3 phase involving a multi-cohort protocol, harmonized interventions, measures and resources. For the subsequent UH3 phase, we propose a Hybrid Type 1 effectiveness-implementation trial in which we recruit 550 perinatal women who will be randomized to receive EBHV alone or EBHV enhanced with our lifestyle intervention to promote CVH. Our primary hypothesis is that, over an average of 36 months, EBHV+CVH (vs. EBHV alone) will result in more favorable maternal and child levels of the Life’s Simple 7 indicators. We will also examine key intervention moderators, focusing on social determinants of health, and mediators, including changes in the home environment, social support, CVH behaviors, and program adherence. Using the RE-AIM framework, we will determine reach, effectiveness, adoption, implementation, and maintenance of EBHV+CVH vs. EBHV alone. Other goals are to empower and reduce burnout among home visitors; develop skills of early-stage investigators, and propose innovative ancillary studies to enhance the scientific contributions. Our team is exceptionally well positioned for this research and includes established investigators with decades of experience conducting NIH funded research, outstanding early stage investigators, and EBHV sites from Central California and Rhode Island.