Optimizing health from pregnancy through one year postpartum: A sequential multiple assignment randomized trial (SMART) of perinatal lifestyle intervention

摘要 我们目前正在招募超重/肥胖的女性(孕前体重指数≥25) 一项为期两个阶段的生活方式干预的随机试验 产后一年(R01HL132578)。回应NOT-OD-21-071《行政补充和紧急事项》 对美国国立卫生研究院拨款的竞争性修订，以增加或扩大专注于孕产妇健康、结构性研究的研究 种族主义与歧视(SRD)和新冠肺炎，“我们建议加强我们正在进行的审判的目标 围产期生活方式干预，“优化孕期到产后一年的健康：A 围产期生活方式干预的序贯多重分配随机试验[SMART] 新冠肺炎大流行与结构性种族主义和歧视(SRD) 影响围产期健康和心理健康。我们建议通过几种方式加强我们正在进行的试验的目标。 首先，我们旨在评估新冠肺炎大流行对体重、体重相关行为的影响， 孕前超重/肥胖妇女的抑郁症状和心理社会压力 怀孕至产后6个月，并检查行为和心理社会干预的可能性 在围产期分娩，以减轻大流行对产妇健康的负面影响 心理健康。第二，我们建议增加对粮食不安全和种族歧视的评估。给定 新冠肺炎疫情对黑人女性健康的不成比例影响，我们将通过以下方式增加样本 再招募40名黑人孕妇(孕前体重指数≥25)。增加了对食品的评估 不安全感和歧视将补充饮食摄入量、体力活动、抑郁 在父母R01中收集的症状、心理社会压力、睡眠和体重。干预组件，如 如心理教育、指导、目标设定和与健康行为促进、情绪和支持相关的支持 压力管理可以应对与大流行相关的压力源，以及无数的挑战和担忧 女性在怀孕和产后都要面对。本补编的目的是：(1)审查 新冠肺炎大流行对体重、体重相关行为、抑郁症状和心理社会压力的影响 在怀孕结束和产后6个月超重/肥胖的妇女；(2)确定 围产期生活方式干预可减轻与大流行相关的体重、体重相关的负面影响 行为和心理健康；以及(3)评估与以下方面有关的粮食不安全和感觉到的歧视 母亲体重、心理健康结果和生活方式干预反应。因此，我们的目标是利用 正在进行的R01通过记录潜在的生活方式来为改善护理提供证据基础 减轻新冠肺炎疫情对围产期孕产妇健康和心理的负面影响的干预措施 健康。

ABSTRACT We are currently recruiting women with overweight/obesity (prepregnancy BMI ≥ 25) at the beginning of pregnancy into a two-stage randomized trial of lifestyle interventions delivered across pregnancy and the first year postpartum (R01HL132578). In response to NOT-OD-21-071 “Administrative Supplements and Urgent Competitive Revisions for NIH Grants to Add or Expand Research Focused on Maternal Health, Structural Racism and Discrimination (SRD), and COVID-19,” we propose to enhance the aims of our ongoing trial of perinatal lifestyle interventions, “Optimizing Health from Pregnancy through One Year Postpartum: A Sequential Multiple Assignment Randomized Trial [SMART] of Perinatal Lifestyle Intervention” to address questions about the ways in which the COVID-19 pandemic and structural racism and discrimination (SRD) affect perinatal health and mental health. We propose to enhance the aims of our ongoing trial in several ways. First, we aim to evaluate the effects of the COVID-19 pandemic on weight, weight-related behaviors, depressive symptoms, and psychosocial stress among women with prepregnancy overweight/obesity from pregnancy to 6 months postpartum and examine the potential for behavioral and psychosocial intervention delivered during the perinatal period to attenuate negative effects of the pandemic on maternal health and mental health. Second, we propose to add assessments of food insecurity and racial discrimination. Given the disproportionate effects of the COVID-19 pandemic on Black women’s health, we will enhance our sample by recruiting 40 additional Black pregnant women (prepregnancy BMI ≥ 25). The added assessments of food insecurity and discrimination will supplement measures of dietary intake, physical activity, depressive symptoms, psychosocial stress, sleep, and weight collected in the parent R01. Intervention components such as psychoeducation, coaching, goal-setting, and support related to health behavior promotion, mood and stress management can address stressors related to the pandemic, and the myriad challenges and concerns women face during pregnancy and postpartum. The aims of this supplement are to: (1) Examine the impact of the COVID-19 pandemic on weight, weight-related behaviors, depressive symptoms, and psychosocial stress in women with overweight/obesity at the end of pregnancy and 6 months postpartum; (2) Determine whether perinatal lifestyle intervention attenuates negative pandemic-related effects on weight, weight-related behaviors and mental health; and (3) Evaluate food insecurity and perceived discrimination in relation to maternal weight, mental health outcomes, and lifestyle intervention response. Thus, we aim to leverage the ongoing R01 to contribute an evidence base to improve care by documenting the potential for lifestyle intervention to attenuate negative impacts of the COVID-19 pandemic on perinatal maternal health and mental health.