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

项目摘要/摘要 心血管疾病(CVD)是美国女性的主要死亡原因，约占 每三名女性死亡人数中。肥胖可以说是预防心血管疾病干预措施的最强可修改目标 它与几乎所有其他主要的心血管疾病危险因素有关，包括高血压、高血糖、高 胆固醇、不良饮食和缺乏体力活动。母亲肥胖的婴儿也面临着更高的风险 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方法，它可以远程 在西班牙裔和非西班牙裔美国人中提供并非常成功地减轻体重和改善CVH 孕期和产后的妇女和儿童。现在至关重要的是研究传播这一信息的方法 经过经验验证的计划。循证家访计划(EBHV)，支持来自 通过婴儿期和幼儿期的产前阶段，是促进CVH的理想环境，然而这些 项目的设计并没有明确关注肥胖和其他心血管疾病风险因素的预防。这个 拟议的研究将测试我们出生前和出生后生活方式干预的有效性，作为一种增强 以EBHV促进母婴CVH。在最初的两年UG3阶段，我们将：1)修改我们的预 和出生后干预，重点关注EBHV内的CVH；2)与我们的EBHV合作伙伴合作，整合CVH 宣传信息并培养相关技能；3)加强医疗保健提供者与EBHV之间的合作 增加转介、留存和改善CVH，以及4)促进高影响力研究的发展 设计后续UH3阶段，涉及多队列方案、协调干预措施、措施 和资源。对于随后的UH3阶段，我们建议进行混合类型1有效性-实施试验 我们招募了550名围产期妇女，她们将被随机分为单独接受EBHV或EBHV增强的两组 通过我们的生活方式干预来促进CVH。我们的主要假设是，在平均36个月的时间里， EBHV CVH(与EBHV单独相比)将产生更有利的母婴水平 指标。我们还将审查主要的干预主持人，重点是健康的社会决定因素，以及 中介者，包括家庭环境、社会支持、CVH行为和计划的变化 坚持不懈。使用RE-AIM框架，我们将确定覆盖范围、有效性、采用、实施、 与单纯EBHV相比，EBHV CVH的维持。其他目标是增强和减少员工的职业倦怠 家访；培养早期调查人员的技能，并提出创新的辅助研究以加强 科学贡献。我们的团队在这项研究中处于非常有利的地位，包括 拥有数十年NIH资助研究经验的调查人员，出色的早期阶段 调查人员，以及来自加利福尼亚州中部和罗德岛的EBHV地点。

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.