Performance Nutrition for Residents on Nighttime Rotations
赞助:
Stanford University
合作者:
信息的提供 (责任方):
Tait Shanafelt，Stanford University
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 25, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Difference in Motor Praxis scores between conditions[ Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights ] Motor Praxis is a validated neurocognitive test that assesses sensory-motor speed. This test takes approximately 30 seconds to complete. Differences in accuracy, duration and composite scores measured at two time points (beginning and end of each night shift) in each of the 3 conditions will be reported and compared. Difference in Fractal 2-Back between conditions[ Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights ] Fractal 2-Back is a validated neurocognitive test that assess working memory. This test takes approximately 2 minutes to complete. Differences in reaction time, accuracy and composite scores measured at two time points (beginning and end of each night shift) in each of the 3 conditions will be reported and compared. Difference in Balloon Analog Risk between conditions[ Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights ] Balloon Analog Risk is a validated neurocognitive test that assess risk decision making. This test takes approximately 2 minutes to complete. Differences in risk propensity, duration and composite scores measured at two time points (beginning and end of each night shift) in each of the 3 conditions will be reported and compared. Difference in Psychomotor vigilance test between conditions[ Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights ] Psychomotor vigilance test is a validated neurocognitive test that assess vigilant attention. This test takes approximately 3 minutes to complete. Differences in risk propensity, duration and composite scores measured at two time points (beginning and end of each night shift) in each of the 3 conditions will be reported and compared. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Performance Nutrition for Residents on Nighttime Rotations | ||
| 正式标题 ICMJE | Performance Nutrition for Residents on Nighttime Rotations: A Pilot Study | ||
| 简要概况 | Currently, residents commonly experience dehydration and poor nutrition during nighttime duty hours as a result of heavy work load, lack of time to take nutrition and hydration breaks, or limited or no access to healthy food and drinks which may affect residents' work performance. The goal of this study is to compare the effects of two different meal compositions with no typical dietary practices (existing conditions) on work performance of the on-call residents during night shifts. |
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| 详细说明 | The purpose of this study is to determine the effects of dietary modifications on resident physicians' work performance during night shifts. Specific objectives are: 1. To assess the effects of macronutrient composition of the test meals on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty. 2. To compare to no intervention, the effects of providing meals before 22:00 hours, and only providing chewing gum, tea, coffee and water onwards to on-call residents, on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: Study participants will participate in the study 3 nights with one control night and two dietary interventions nights.The order of the 2 dietary intervention groups will be randomized per block. There are two possible combinations and the order will be randomized using a computer-generated random-number sequence. There will be a one day washout period between the diet groups. A: Control- no intervention, B: intervention 1 arm, C: Intervention 2 The order of the blocks will be randomized. block a: A, B, washout day, C block b: A, C, washout day, B 盲法: Interventional 盲法描述:Researchers who assess the outcomes and analyze the data will be blinded to the group assignment. 主要目的: Other |
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| 干预项目 ICMJE |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
100 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 2019 | ||
| 预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - All residents and fellows performing in hospital overnight work - Must be able to eat plant source foods (e.g. soy, nuts, seeds) and animal source foods (e.g. meat, eggs, dairy products) Exclusion Criteria: - Food allergies or sensitivies - Prior anaphylactic reaction to food - Strict dietary restrictions (e.g. vegan, gluten free) | ||
| 性别 |
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| 年龄 | 最小年龄：21 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Tait Shanafelt，Stanford University | ||
| 研究赞助商 ICMJE | Stanford University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Stanford University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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