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

摘要 我们目前正在招募开始时超重/肥胖（孕前BMI ≥ 25）的女性， 将妊娠分为两个阶段的生活方式干预随机试验， 产后1年（R 01 HL 132578）。针对NOT-OD-21-071“行政补充和紧急 NIH赠款的竞争性修订，以增加或扩大专注于孕产妇健康，结构 种族主义和歧视（SRD）和COVID-19，“我们建议加强我们正在进行的试验的目的， 围产期生活方式干预，“从怀孕到产后一年的健康优化： 序贯多分配随机试验[SMART]围产期生活方式干预”，以解决 关于COVID-19大流行和结构性种族主义和歧视（SRD） 影响围产期健康和心理健康。我们建议以几种方式加强我们正在进行的审判的目的。 首先，我们的目标是评估COVID-19大流行对体重，体重相关行为， 抑郁症状和心理社会压力的妇女孕前超重/肥胖， 怀孕到产后6个月，并检查行为和心理社会干预的潜力 在围产期分娩，以减轻这一流行病对产妇健康的不利影响， 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。鉴于 鉴于COVID-19大流行对黑人女性健康的不成比例的影响，我们将通过以下方式增强我们的样本： 另外招募40名黑人孕妇（孕前BMI ≥ 25）。食品的附加评估 不安全感和歧视将补充饮食摄入量、身体活动、抑郁 症状、心理社会压力、睡眠和体重在父母R 01中收集。干预成分，如 作为心理教育，辅导，目标设定，以及与健康行为促进，情绪和 压力管理可以解决与大流行病有关的压力源以及各种挑战和关切 妇女在怀孕期间和产后面临的问题。本补充材料的目的是：（1）检查 COVID-19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 在妊娠末期和产后6个月超重/肥胖的女性中;（2）确定是否 围产期生活方式干预减弱了对体重、体重相关 行为和心理健康;（3）评估粮食不安全和与以下方面有关的歧视 产妇体重、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R 01，通过记录生活方式的可能性，为改善护理提供证据基础 采取干预措施，减轻COVID-19大流行对围产期孕产妇健康和心理的负面影响 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.