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，并始终与妇女和婴儿的不良结局相关，包括自发性流产、先兆子痫、手术分娩和产后抑郁的发生率较高。抑郁孕妇的婴儿更有可能早产，并经历更多的语言和认知延迟，焦虑症和注意力缺陷/多动症。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，迫切需要评估有效减轻症状和更容易为孕妇接受和获得的干预措施。增加身体活动作为减少抑郁症状的策略有许多优点。中等强度的运动可以有效降低未怀孕者的抑郁症状水平。它也便宜，安全，并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身体活动，但在实践中，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，一个量身定制的，支持的体力活动干预将是可以接受的抑郁症孕妇，将优于药物治疗。增加体力活动可能会减少抑郁症状，包括生理，行为和心理因素。然而，到目前为止，还没有研究评估身体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温和的，为期10周的，基于计步器的步行干预措施，专为孕妇设计，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。该方案的设计成本低，便于在社区环境中提供。我们在一项开放试验中评估了PWP，并发现了干预的可行性、可接受性和安全性的证据。此外，参与者报告抑郁症状和功能改善显着减少。R 01申请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）条件的比较。152名孕妇将被随机分配到PWP或HEC组，并将在妊娠和产后的多个时间点完成盲态评估。主要目的是检查PWP组相对于HEC是否有更大的抑郁症状减少。此外，将评估几个关键的产妇健康和功能结果，婴儿神经行为检查将允许检查组间差异。还将测试潜在的机制，包括行为因素（行为激活，减少回避），心理因素（增加自我效能）和生理因素（减少炎症，改善睡眠）。