- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01739569
Effect of Healthy Lunch and Snack Meal on Reaction Time and Well-being of Physicians and Nursing Staff (Go-No-Go)
Long-term Effect of Healthy Lunch and Snack Meal on Reaction Time and Well-being: A Randomised Controlled Intervention in Physicians and Nursing Staff.
The aim of this study is to investigate the impact of increased availability of healthy food and drink during working hours on reaction time and well-being in physicians and nursing staff.
Hospital medical staff often works long and hectic hours, without adequate meal or rest breaks in order to provide 24-hour care. This is a concern, as not only the staff's well-being is important to the individual welfare, but it is also vital to the quality and safety of the care their patients receive. The investigators believe that by focusing on physicians and nursing staffs nutrition the investigators will see a positive effect on staff performance and well-being - and thus ultimately possibly on patient safety.
Hypothesis: The provision of healthy lunch and snack meal during working hours for a period of 4 weeks will improve reaction time and well-being compared to habitual diet in physicians, nurses and nursing assistants.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Copenhagen
-
Herlev, Copenhagen, Denmark, 2730
- EFFECT, Copenhagen University Hospital at Herlev
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Employed in Herlev University Hospital as physician, nurse or nursing assistant (males and females)
- Age 20-70 years
- BMI 18,5-30 kg/m2
- Work at least 30 h/wk
- Have daily contact with patients and/or have responsibilities that may affect patient safety
- Primarily work in day- or evening shifts during the study period
- Not having any intentions of loosing weight or changing lifestyle habits during the study period
- Not suffer from any diseases that might affect dietary intake (e.g. food allergies, food intolerance)
- Not dine in the staff canteen, the Diastole, more than once a week
- Be able to write and understand the Danish language
Exclusion Criteria:
- For those working >35 h/wk having holiday/ time off duty for more than 9 consecutive days during the study period.
- For those working <35 h/wk having holiday/time off duty for more than 5 consecutive days during the study period
- Not to be able to attend the planned tests in the study
- Pregnancy
- Intensive physical exercise (e.g. strength training) > 5 hours/wk
- Suffer from food allergies or - intolerance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dietary treatment
Dietary treatment with healthy lunch and snack meal during working hours
|
Dietary treatment with healthy lunch and snack meal during working hours
|
|
No Intervention: Habitual meals
Dietary treatment with habitual diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reaction-time
Time Frame: week 0, week 5 and week 9
|
Differences in reaction-time, as measured by the reaction time test Go/No-Go, a subtest of Test-battery for Attentional Performance from baseline (week 0) to week 4 in the intervention period and week 4 in the control period.
|
week 0, week 5 and week 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary intake
Time Frame: Week 0, week 5, week 9
|
Differences in dietary intake with respect to macronutrient composition, meal pattern and choice of food items measured by self-reported records during 4 working days using a standardized dietary record form
|
Week 0, week 5, week 9
|
|
Physical activity
Time Frame: Week 0, week 5, week 9
|
Differences in 24-hours physical activity measured by self-reported records during four working days using a standardized physical activity record form.
|
Week 0, week 5, week 9
|
|
Palatability of the diet eaten during working hours
Time Frame: Week 0, week 5 and week 9
|
Differences in palatability of the intervention diet compared to the control diet measured by scores using a specific and standardized Visual Analouge Scale (VAS-scores).
|
Week 0, week 5 and week 9
|
|
Well-being
Time Frame: Week 0, week 5 and week 9
|
Differences in selfreported well-being, as measured by the POMS Questionaire (McNair et.al.
Manual of the Profile of Mood States.
San Diego:Educational and Industrial Testing Service;1981) form baseline (week 0) to week 4 in the intervention period and week 4 in the control period.
|
Week 0, week 5 and week 9
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christian Bitz, Cand Scient, Copenhagen University Hospital at Herlev
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EFFECT.A01.2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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