怀孕干预 (SPRING) 中减少久坐行为的推理,设计和方法:试点和可行性随机对照试验协议
Bethany Barone Gibbs1, Andrea C Kozai2, Shannon N McAdoo2
1Department of Epidemiology and Biostatistics, West Virginia University School of Public Health, Morgantown, WV, United States.
JMIR research protocols
|June 14, 2023
概括
春季RCT试点研究正在测试一种新的干预措施,以减少孕妇的久坐行为. 这项研究旨在为一个更大的试验提供信息,以减少不良妊娠结果.
科学领域:
- 产科和妇科 产科和妇科
- 心血管健康 心血管健康
- 公共卫生 公共卫生
背景情况:
- 妊娠不良结果 (APO) 与心血管疾病风险有关.
- 怀孕期间的高度久坐行为 (SED) 是 APO 的潜在危险因素.
- 很少有干预措施可以减少SED在怀孕期间.
研究的目的:
- 评估在怀孕干预中减少久坐行为 (SPRING) 试验RCT的可行性和可接受性.
- 评估SPRING干预措施对母胎健康的初步影响.
- 为设计一项更大的APO风险降低临床试验提供信息.
主要方法:
- 一个试点和可行性随机对照试验 (RCT) 涉及53名高风险SED和APO的孕妇.
- 参与者被随机分配2:1到干预组或对照组.
- 客观测量SED,站立时间和使用加速度计跨季度的步骤.
- 一个多元组件的干预,包括一个高度可调的工作站,活动监视器,行为咨询和社交媒体支持.
- 干预的目标是每天达到<9小时SED和≥7500步的目标,每小时有运动休息.
主要成果:
- 这项研究由美国心脏协会 (2021年1月至2023年12月) 资助.
- 参与者随机化发生于2021年10月至2022年9月.
- 最终数据收集计划于2023年5月进行,预计结果将在2023年冬季发布.
结论:
- 春季RCT将提供关于SED减少干预措施在孕妇的可行性和可接受性的关键数据.
- 结果将指导大规模临床试验的发展.
- 这项研究可能会通过减少SED来减少APO风险的新策略.
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