Intervention to promote physical activation and improve sleep and feeding practices in infants for preventing obesity early in life (The Baby-Act Trial)

项目摘要 在美国，婴儿肥胖症正在增加，特别是在拉美裔美国人中。在关键时期体重迅速增加 婴儿期增加了儿童肥胖的风险，持续到成年并增加了慢性肥胖症的风险 糖尿病和高血压等疾病。这一严重的健康威胁可以通过多方面的措施来预防 婴儿期的干预措施，解决与早期肥胖发展相关的多种风险因素。当前 有证据表明，试验应该特别关注与体力活动、睡眠、营养、 饱腹感、压力和不断提高的育儿技能，并应在多个层面上提供，使用人口层面 计划要可翻译、成本效益高和可持续。为此，在联合国系统内进行的干预 联邦WIC计划提供了一种潜在的强大方式来培养早期健康的行为并帮助 预防肥胖。作为WIC计划的一部分进行的成功干预可以转化为他们的 政策，因为每个州都制定了自己的教育材料，并决定了营养教育的方式 实施。我们的目标是测试多方面、多层次干预的临床有效性。 重点关注三个主要领域：体力活动(即婴儿活动、睡眠和屏幕时间)、营养和 健康自我赋权理论框架中的成长监测，并通过WIC计划提供 使用多媒体方法。体力活动和生长监测组件是WIC的新功能 课程，而营养部分基于WIC指南，但提供不同的方式(通过自我 基于赋权的信息和基于多媒体的信息)。为此，我们将进行随机分组 在波多黎各WIC(PR-WIC)计划的孕妇参与者中进行对照试验。平起平坐 诊所的数量将随机分为对照组(常规护理)或WIC+组(常规护理+干预) 把武器放在圣胡安地区。生活方式干预将侧重于适龄婴儿的身体活动， 健康的睡眠和限制看屏幕的时间，健康的饮食模式和成长监测。内容将是 采用多媒体方式(网络平台、手机短信和电话跟踪)。参与 干预将从怀孕的最后三个月开始，一直持续到婴儿12个月大。我们 已经在第一年的10对母婴中试行了这种干预的信息 具有极好的可接受性。我们将确定干预措施可能影响到的程度 与对照组相比，从出生到12个月的体重增加、婴儿活动和营养。我们还将 评估此次干预的成本，将其作为当前WIC课程的修改。这种方法并没有 以前在婴儿中进行过测试。如果成功，这种干预可能会被采纳为政策支持的最佳方案 通过PR-WIC计划的实践，帮助预防婴儿肥胖。这将有助于改善少数群体的健康和 消除拉美裔和其他高危群体之间的健康差距。

Project Summary Infant obesity is increasing in the U.S., particularly among Hispanics. Rapid weight gain during critical periods of infancy increases the risk of obesity in childhood, continuing into adulthood and increasing the risk of chromic diseases such as diabetes and hypertension. This serious health threat could be prevented through multifaceted interventions during infancy that address multiple risk factors associated with early obesity development. Current evidence suggests that trials should focus particularly on risk factors related to physical activity, sleep, nutrition, satiety, stress and increasing parenting skills, and should be delivered at multiple levels, using population-level programs to be translatable, cost-effective and sustainable. To this end, interventions carried out within the federal WIC program provide a potentially powerful way of fostering early healthy behaviors and helping in preventing obesity. Successful interventions done as part of the WIC program could be translated into their policies, since each state develops its own educational materials and determines how nutritional education is implemented. Our goal is to test the clinical effectiveness of a multi-faceted and multi-leveled intervention focusing on three main areas: physical activity (i.e., infant activation, sleep and screen time), nutrition and growth monitoring, framed in the Health Self-Empowerment Theory, and delivered through the WIC Program using a multi-media approach. The physical activity and growth-monitoring components are new to the WIC curriculum, while the nutrition component is based on WIC guidelines but delivered differently (through self- empowerment-based messages and multi-media based). For this, we will conduct a cluster-randomized controlled trial among pregnant women participants of the Puerto Rico WIC (PR-WIC) program. An equal number of clinics will be randomized to the control (usual care) arm or to the WIC+ (usual care + intervention) arm in the San Juan area. The lifestyle intervention will focus on age-appropriate infant physical activation, healthy sleep and limiting screen time, healthy dietary patterns and growth monitoring. The content will be delivered with a multi-media approach (web-platform, mobile messages and phone follow-up). Participation in the intervention will begin in the last trimester of pregnancy and continue until the infant is 12 months old. We have already pilot-tested the information of this intervention among 10 mother-infant dyads during their first year of life, with excellent acceptability. We will determine the extent to which the intervention may impact adequate weight gain, infant activity and nutrition from birth to 12 months of age compared to the control arm. We will also evaluate the cost of this intervention as a modification of the current WIC curriculum. Such approach has not been tested before among infants. If successful, this intervention could be adopted as a policy-supported best practice by the PR-WIC program to help prevent infant obesity. This will help improve minority health and eliminate health disparities among Hispanics and other at-risk groups.