Performance Nutrition for Residents on Nighttime Rotations

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Tait Shanafelt，Stanford University

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Difference in Degree of sleepiness between conditions[ Time Frame: Two time points (beginning and end of night shifts) on each night for a total of 3 nights ]
Will use validated Stanford Sleepiness Scale (SSS) developed by William C. Dement, M.D., Ph.D. SSS a self-rating scale used to quantify progressive steps in sleepiness at a certain point in time. It is a seven-point Likert-type scale ranging from "feeling active, vital alert, or wide awake" (score = 1) to "no longer fighting sleep, sleep onset soon and having dream-like thoughts" (score = 7). Selected scores by the participants will be reported each time. This test takes approximately 15 seconds to complete. Differences in degree of sleepiness measured at two time points (beginning and end of each night shift) in each of the 3 conditions will be reported and compared.

Descriptive Information

Brief Title ^ICMJE

Performance Nutrition for Residents on Nighttime Rotations

Official Title ^ICMJE

Performance Nutrition for Residents on Nighttime Rotations: A Pilot Study

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: Interventional
Masking Description:Researchers who assess the outcomes and analyze the data will be blinded to the group assignment.
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

Other: Dietary Modification
Participants will be provided with meals, snacks and drinks with specific macronutrient compositions and encouraged to only eat and drink study meals, snacks and drinks and to avoid eating after 10:00 hours.

Study Arms

Experimental: Dietary Modification
On the first night of the study, participants can eat and drink as they normally would (no dietary intervention). On second and third nights participants will be provided meals, snacks and drinks with specific macronutrient composition, encouraged to only eat and drink study meals, snacks and drinks, and to avoid eating after 10:00 hours. The composition of the study foods and drinks on nights 2 and 3 will be different.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 2019

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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)

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Tait Shanafelt，Stanford University

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Tait D Shanafelt, MD Stanford University

PRS Account

Stanford University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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