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

Healthy Hearts/Corazones Saludables：在美国家访计划中合作促进西班牙裔和非西班牙裔母亲和儿童的心血管健康

• 批准号: 10618401
• 负责人: Stephanie Hart Parade
• 金额: $ 74.34万
• 依托单位: CALIFORNIA POLY STATE U SAN LUIS OBISPO
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10618401
• 关键词: Accounting; Adherence; Affect; Ancillary Study; Behavior; Blood Pressure; Body Weight; Body Weight decreased; Body mass index; Breast Feeding; California; Cardiovascular Diseases; Cause of Death; Cessation of life; Child; Cholesterol; Development; Diabetes Mellitus; Diet; Early Intervention; Family; Female; Funding; Future; Glucose; Goals; Health Personnel; Health behavior; Heart; Hispanic; Home; Home environment; Home visitation; Hybrids; Hypertension; Infant; Intervention; Life; Link; Low income; Maternal and Child Health; Measures; Mediator; Modeling; Mothers; Not Hispanic or Latino; Obesity; Overweight; Phase; Positioning Attribute; Postpartum Period; Pregnancy; Pregnancy Complications; Prevalence; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Research Design; Research Personnel; Resources; Rhode Island; Risk; Risk Factors; Series; Site; Sleep; Social support; Target Populations; Telephone; Testing; Time; Triglycerides; Unhealthy Diet; United States National Institutes of Health; Woman; Work; black women; burnout; cardiovascular disorder risk; cardiovascular health; cardiovascular risk factor; clinically significant; cohort; design; early childhood; effectiveness evaluation; effectiveness testing; effectiveness/implementation trial; empowerment; evidence base; experience; family support; feeding; gestational weight gain; health of the mother; improved; infancy; innovation; lifestyle intervention; low socioeconomic status; maternal obesity; maternal weight; medication compliance; modifiable risk; obesity prevention; online delivery; perinatal women; physical inactivity; postnatal; postpartum weight; prenatal; prevent; programs; recruit; remote delivery; sedentary; skills; social health determinants; tv watching; underserved community; waist circumference

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.

项目概要/摘要 心血管疾病 (CVD) 是美国女性死亡的主要原因，约占美国女性死亡原因之一 肥胖可以说是预防心血管疾病干预措施中最强有力的可改变目标。 并且与几乎所有其他主要 CVD 危险因素相关，包括高血压、血糖升高、高血压 肥胖母亲的胆固醇、不良饮食和缺乏运动也会增加患此病的风险。 我们的团队开发了一种经过经验验证的远程生活方式干预措施。 在西班牙裔和非西班牙裔中减轻体重和改善 CVH 方面取得了巨大成功 怀孕期间和产后的妇女和儿童现在至关重要的是研究传播这一点的方法。 基于证据的家访计划 (EBHV)，为来自以下地区的家庭提供支持 产前时期到婴儿期和幼儿期是促进 CVH 的理想环境，但是这些 计划的设计并未明确重点关注预防肥胖和其他心血管疾病危险因素。 拟议的研究将测试我们的产前和产后生活方式干预作为增强措施的有效性 EBHV 以促进孕产妇和儿童 CVH 在最初的 2 年 UG3 阶段，我们将： 1) 修改我们的预先计划。 和产后干预，重点关注 EBHV 中的 CVH；2) 与我们的 EBHV 合作伙伴合作，整合 CVH； 信息并发展他们的相关技能；3) 加强医疗保健提供者和 EBHV 之间的合作伙伴关系 增加推荐、保留并改善 CVH，以及 4) 促进高影响力研究的发展 后续 UH3 阶段的设计，涉及多队列协议、统一干预措施、措施 对于随后的 UH3 阶段，我们提出了混合 1 型有效性实施试验。 其中我们招募了 550 名围产期妇女，她们将被随机分配接受单独 EBHV 治疗或 EBHV 强化治疗 通过我们的生活方式干预来促进 CVH 我们的主要假设是，平均在 36 个月内， EBHV+CVH（相对于单独 EBHV）将导致更有利的 Life's Simple 7 孕产妇和儿童水平 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和 调解因素，包括家庭环境、社会支持、CVH 行为和计划的变化 使用 RE-AIM 框架，我们将确定范围、有效性、采用、实施、 EBHV+CVH 与单独 EBHV 的维持其他目标是增强和减少倦怠。 家访人员；培养早期研究人员的技能，并提出创新的辅助研究以加强 我们的团队在这项研究中处于非常有利的地位，其中包括已建立的团队。 研究人员拥有数十年进行 NIH 资助研究的经验，早期阶段表现出色 调查人员以及来自加利福尼亚州中部和罗德岛州的 EBHV 站点。