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

针对减轻孕妇压力的定制步行计划的随机对照试验

• 批准号: 8928655
• 负责人: CYNTHIA L. BATTLE
• 金额: $ 43.44万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-17 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8928655
• 关键词: Adherence; Affect; American College of Obstetricians and Gynecologists; Antidepressive Agents; Anxiety; Anxiety Disorders; Apgar Score; Area; Attention deficit hyperactivity disorder; Behavior; Behavioral; Biological; Birth; Birth Records; Blinded; Caring; Clinic; Cognitive; Communities; Control Groups; Data; Depressed mood; Developmental Delay Disorders; Enrollment; Evaluation; Exercise; Exhibits; Fatigue; Funding; General Population; Growth; Guidelines; Health; Health education; Individual; Infant; Infant Health; Inflammation; Intervention; Interviewer; Language; Lead; Light; Link; Low Birth Weight Infant; Manuals; Maternal Health; Measures; Mediating; Medical; Medical Records; Mental Depression; Mental Health; Moods; Mothers; Neonatal; Neurobiology; Nurses; Outcome; Pain; Participant; Patients; Perinatal; Persons; Pharmacotherapy; Physical activity; Physiological; Postpartum Depression; Postpartum Period; Pre-Eclampsia; Pregnancy; Pregnant Women; Prenatal care; Protocols documentation; Psychological Factors; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Relative (related person); Reporting; Research; Risk; Safety; Self Efficacy; Severities; Sleep; Spontaneous abortion; Stress; Symptoms; Testing; Time; Training Programs; Translating; Walking; Weight; Woman; adverse outcome; base; blind; community setting; comparison group; cost; depressive symptoms; design; efficacy testing; experience; follow-up; functional improvement; improved; infant outcome; interest; intervention program; neurobehavioral; offspring; pregnant; prenatal; prenatal intervention; programs; psychologic; therapy design; treatment effect

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).

描述（由申请人提供）：抑郁症状在孕妇中普遍存在，并且始终与女性和婴儿的不良后果相关，包括较高的自然流产、先兆子痫、手术分娩和产后抑郁的发生率。抑郁孕妇的婴儿更有可能早产，并出现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，但很少有干预措施可以减少产前抑郁症状。由于孕妇往往不愿意服用抗抑郁药（这是最可用的护理形式），因此迫切需要评估可有效减轻症状且更容易被孕妇接受和获得的干预措施。作为减少抑郁症状的策略，增加体力活动有很多好处。中等强度的运动可有效降低未怀孕者的抑郁症状水平。它还便宜、安全，并且与多种积极的健康结果相关。美国妇产科学院强烈建议在整个怀孕期间定期进行体育活动，但实际上，许多孕妇不确定如何安全地遵守这一建议。我们的研究结果表明，针对抑郁症孕妇来说，量身定制的支持性身体活动干预措施是可以接受的，并且比药物治疗更可取。增加体力活动可以减轻抑郁症状，包括生理、行为和心理因素，存在合理的机制。然而，迄今为止还没有研究评估体育活动作为抑郁孕妇的干预措施。我们的团队最近开发了一种专为孕妇设计的温和的、为期 10 周、基于计步器的步行干预措施，即产前步行计划 (PWP)，包括详细的干预手册、干预培训计划和依从性量表。该计划旨在低成本且便于运输，以便在社区环境中实施。我们在公开试验中评估了 PWP，并找到了干预措施的可行性、可接受性和安全性的证据。此外，参与者报告抑郁症状显着减轻，功能得到改善。该 R01 应用的研究计划包括一项功能齐全的 RCT，用于与围产期健康教育控制 (HEC) 条件进行比较来评估 PWP。 152 名孕妇将被随机分配接受 PWP 或 HEC，并将在怀孕期间和产后的多个时间点完成盲法评估。主要目的是检查 PWP 组相对于 HEC 组是否能更大程度地减少抑郁症状。此外，还将评估几个关键的孕产妇健康和功能结果，并且婴儿神经行为检查将允许检查群体差异。潜在的机制也将受到测试，包括行为因素（行为激活、回避减少）、心理因素（自我效能提高）和生理因素（炎症减少、睡眠改善）。