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: 8773951
• 负责人: CYNTHIA L. BATTLE
• 金额: $ 47.18万
• 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/8773951
• 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; public health relevance; 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结果有关，包括较高的自发性流产率，前偏球，手术递送和产后抑郁症。抑郁孕妇的婴儿更有可能出生前期，并且会经历更多的语言和认知延迟，焦虑症以及注意力缺陷 /多动障碍。尽管存在这些风险，但几乎没有采取干预措施来减轻产前抑郁症状。由于孕妇通常不愿服用抗抑郁药，这是最可用的护理形式，因此存在紧迫的需求，以评估有效减轻症状的干预措施，并且更容易被孕妇接受。体育锻炼的增加具有许多优势，作为减轻抑郁症状的策略。中等强度运动可有效降低未怀孕的人的抑郁症状水平。它也很便宜，安全，并且与多种积极的健康结果有关。美国产科医生和妇科医生强烈建议在整个怀孕期间进行定期体育锻炼，但实际上，许多孕妇不确定如何安全地遵守这一建议。我们研究的发现表明，抑郁的孕妇可以接受量身定制的，受支持的体育锻炼干预措施，而不是药物治疗。存在合理的机制，通过增加体育活动可以减少抑郁症状，包括生理，行为和心理因素。然而，迄今为止尚无研究评估体育锻炼作为抑郁孕妇的干预。我们的团队最近开发了一项为孕妇设计的温和，基于计步器的步行仪干预措施（PWP），包括详细的干预手册，干预主义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。我们在公开试验中评估了PWP，并发现了干预措施的可行性，可接受性和安全性的证据。此外，参与者报告了抑郁症状和功能改善的大幅减少。该R01应用程序的研究计划包括一个完全动力的RCT，与以围产期为中心的健康教育控制（HEC）条件相比，可以评估PWP。 152孕妇将被随机分为PWP或HEC，并将在怀孕和产后多个点完成盲目评估。主要目的是检查PWP组相对于HEC的抑郁症状是否更大。此外，还将评估一些关键的母亲健康和功能结果，婴儿神经行为检查将允许检查组差异。还将测试潜在的机制，包括行为因素（行为激活，避免降低），心理因素（自我效能增强）和生理因素（炎症减少，睡眠改善）。