Performance Nutrition for Residents and Fellows

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT03698123

Collaborator

American Medical Association (Other)

Enrollment

Location

Arm

6.4

Actual Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Physician Well-being Cognitive Function Diet Modification Diet Habit Shift-Work Related Sleep Disturbance Sleep Deprivation	Other: Dietary Modification	N/A

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:

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.
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 Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

N/A

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 at least a 24-hour wash-out period between study nights to minimize the carry-over effects of the cross-over design as well as learning effects of the computerized cognitive tests. A: Control- no intervention, B: intervention 1 arm, C: Intervention 2 The order of the blocks will be randomized. block a: A, B, C block b: A, C, BStudy 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 at least a 24-hour wash-out period between study nights to minimize the carry-over effects of the cross-over design as well as learning effects of the computerized cognitive tests. A: Control- no intervention, B: intervention 1 arm, C: Intervention 2 The order of the blocks will be randomized. block a: A, B, C block b: A, C, B

Masking:

None (Open Label)

Masking Description:

Researchers analyze the data will be blinded to the group assignment.

Primary Purpose:

Other

Official Title:

Performance Nutrition for Residents and Fellows Working Overnight Shifts: A Pilot Study

Actual Study Start Date :

Oct 29, 2018

Actual Primary Completion Date :

May 11, 2019

Actual Study Completion Date :

May 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Difference in Motor Praxis scores between conditions [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 and will be measured at two time points (beginning and end of each night shift) in each of the 3 conditions . Differences in accuracy (percentage of correct responses, a higher percentage is better), duration (in milliseconds, lower duration is better), reaction time (in milliseconds, lower reaction time is better) and composite scores (0-1000, higher score is better) will be reported and compared.
Difference in Fractal 2-Back between conditions [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 and will be measured at two time points (beginning and end of each night shift) in each of the 3 conditions. Differences in reaction time (in milliseconds, lower reaction time is better) , accuracy (percentage of correct responses, a higher percentage is better) and composite scores (0-1000, higher score is better) will be reported and compared.
Difference in Balloon Analog Risk between conditions [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 and will be measured at two time points (beginning and end of each night shift) in each of the 3 conditions. Differences in risk propensity (higher scores indicative of greater risk-taking propensity), duration (in milliseconds, lower reaction time is better) and composite scores (0-1000, higher score is better) will be reported and compared.
Difference in Psychomotor vigilance test between conditions [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 will be measured at two time points (beginning and end of each night shift) in each of the 3 conditions. Differences in reaction time (in milliseconds, lower reaction time is better), lapses (number, less is better) and composite scores measured (0-1000, higher score is better) will be reported and compared.

Secondary Outcome Measures

Difference in Degree of sleepiness between conditions [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.

Other Outcome Measures

Difference in Work Exhaustion between conditions [Two time points (beginning and end of night shifts) on each night for a total of 3 nights]
Work Exhaustion scale, developed and modified by Mickey Trockel MD, PhD, to explore the degree of work related fatigue in residents and fellows. It has 4 questions with a 5 point Likert scale ranging from not at all to extremely. This test takes approximately 30 second to complete. The total score is the average scores of the 4 items and falls between 0 and 4. Scores equal to higher than 1.33 indicate work-related fatigue. Differences in Work Exhaustion scores measured at two time points (beginning and end of each night shift) in each of the 3 conditions will be reported and compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)