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，并一直与妇女和婴儿的不良后果有关，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，并经历更多的语言和认知延迟、焦虑障碍和注意力缺陷/多动障碍。尽管有这些风险，但很少有干预措施被开发来减少产前抑郁症状。由于孕妇往往不愿服用最有效的护理形式--抗抑郁药，因此迫切需要评估能有效缓解症状、更容易为孕妇接受和获得的干预措施。作为减轻抑郁症状的一种策略，增加体力活动有很多好处。中等强度的运动可以有效地降低未怀孕的人的抑郁症状水平。它也是廉价、安全的，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，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，抑郁症孕妇可以接受量身定做的、有支持的体力活动干预，而且比药物治疗更可取。增加体力活动可以减少抑郁症状，包括生理、行为和心理因素，这一机制似乎是存在的。然而，到目前为止，还没有研究将体育活动评估为对抑郁孕妇的干预。我们的团队最近开发了一种针对孕妇的温和、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、干预者培训计划和依从性量表。该计划旨在低成本和可运输，以便在社区环境中交付。我们在一项公开试验中评估了PWP，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显著减少，功能改善。这一R01应用的研究计划包括一项全功率随机对照试验，以评估PWP与以围产期为重点的健康教育控制(HEC)条件的比较。152名孕妇将被随机分配到PWP或HEC，并在怀孕和产后的多个时间点完成盲法评估。主要目的是检验与HEC相比，PWP组的抑郁症状是否有更大的减少。此外，还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(增加自我效能)，以及生理因素(减少炎症，改善睡眠)。