RCT of a tailored walking program to reduce stress among pregnant women

描述（由申请人提供）：抑郁症状在孕妇中普遍存在，并且始终与妇女和婴儿的不良后果相关，包括较高的自然流产率、先兆子痫、手术分娩和产后抑郁。抑郁孕妇的婴儿更有可能早产，并且会经历更多的语言和认知迟缓、焦虑症和注意力缺陷/多动障碍。尽管存在这些风险，但很少有干预措施能够减少产前抑郁症状。由于孕妇往往不愿服用抗抑郁药，而抗抑郁药是最容易获得的治疗形式，因此迫切需要评估哪些干预措施能有效减轻症状，并为孕妇更容易接受和获得。增加体育锻炼作为一种减少抑郁症状的策略有很多好处。中等强度的运动对降低未怀孕个体的抑郁症状水平有效。它还便宜、安全，并与多种积极的健康结果相关。美国妇产科医师学会强烈建议在怀孕期间定期进行体育锻炼，然而，在实践中，许多孕妇不确定如何安全地坚持这一建议。我们的研究结果表明，量身定制的、有支持的体育活动干预对抑郁症孕妇来说是可以接受的，而且比药物治疗更可取。增加体力活动可能减轻抑郁症状的合理机制存在，包括生理、行为和心理因素。然而，到目前为止，还没有研究评估体育活动对抑郁症孕妇的干预作用。我们的团队最近开发了一种温和的，为期10周的，基于计步器的孕妇步行干预，产前步行计划（PWP），包括详细的干预手册，干预人员培训计划和依从性量表。该计划的设计成本低，可在社区环境中运输。我们在一项公开试验中评估了PWP，并找到了干预的可行性、可接受性和安全性的证据。此外，参与者报告抑郁症状显著减轻，功能改善。该R01应用程序的研究计划包括一项全功率RCT，以评估PWP与围产期健康教育控制（HEC）状况的比较。152名孕妇将被随机分配到PWP或HEC组，并将在怀孕和产后的多个时间点完成盲测。主要目的是检查与HEC相比，PWP组是否有更大程度的抑郁症状减轻。此外，将评估几项关键的产妇保健和功能结果，婴儿神经行为检查将允许检查群体差异。潜在的机制也将被测试，包括行为因素（行为激活，减少回避），心理因素（提高自我效能）和生理因素（减少炎症，改善睡眠）。

DESCRIPTION (provided by applicant): Depressive symptoms are prevalent among pregnant women and consistently linked with adverse outcomes for both women and infants, including higher rates of spontaneous abortion, preeclampsia, operative delivery, and postpartum depression. Infants of depressed pregnant women are more likely to be born pre-term, and experience more language and cognitive delays, anxiety disorders, and attention deficit / hyperactivity disorder. In spite of these risks, few interventions have been developed to reduce prenatal depressive symptoms. Because pregnant women are often reluctant to take antidepressants, the most available form of care, a pressing need exists to evaluate interventions that are efficacious in reducing symptoms and more acceptable and accessible to pregnant women. Increased physical activity has numerous advantages as a strategy to decrease symptoms of depression. Moderate intensity exercise is effective in lowering depressive symptom levels among individuals who are not pregnant. It is also inexpensive, safe, and associated with multiple positive health outcomes. The American College of Obstetricians and Gynecologists strongly recommends regular physical activity throughout pregnancy, yet, in practice, many pregnant women are unsure of how to safely adhere to this recommendation. Findings from our research indicate that a tailored, supported physical activity intervention would be acceptable to depressed pregnant women and would be preferable over pharmacotherapy. Plausible mechanisms exist by which increased physical activity may reduce depressive symptoms, including physiological, behavioral and psychological factors. No study to date, however, has evaluated physical activity as an intervention for depressed pregnant women. Our team recently developed a gentle, 10-week, pedometer-based walking intervention designed for pregnant women, the Prenatal Walking Program (PWP), including detailed intervention manuals, interventionist training programs, and adherence scales. The program is designed to be low-cost and transportable for delivery in community settings. We evaluated PWP in an open trial and found evidence for the feasibility, acceptability, and safety of the intervention. In addition, participants reported significant reductions in depressive symptoms and functional improvements. The research plan for this R01 application includes a fully-powered RCT to evaluate PWP in comparison with a perinatal-focused Health Education Control (HEC) condition. 152 pregnant women will be randomized to PWP or HEC and will complete blind assessments at multiple points across pregnancy and postpartum. The primary aim is to examine whether the PWP group has greater reductions in depressive symptoms relative to HEC. In addition, several key maternal health and functioning outcomes will be assessed, and infant neurobehavioral exams will allow for examination of group differences. Potential mechanisms will also be tested, including behavioral factors (behavioral activation, decreased avoidance), psychological factors (increased self-efficacy), and physiological factors (decreased inflammation, improved sleep).