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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01739569
Other study ID # EFFECT.A01.2012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2012
Est. completion date December 2012

Study information

Verified date December 2022
Source Copenhagen University Hospital at Herlev
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The study is designed as a randomised controlled 2 x 4 weeks cross-over trial, initiated with a 1-week run-in period. The study sample will consist of 60 volunteer physicians, nurses and nursing assistants from Herlev University Hospital in Copenhagen, Denmark. A healthy lunch and snack meal meeting the current danish diet recommendations will be delivered daily during all working days in the intervention period. During the control period, the participants are requested to maintain their habitual dietary intake at work. Reaction time will be assessed by reaction time test Go/No-Go, a subtest of Test-battery for Attention Performance. Changes in mood will be measured by the Profile of Mood State questionnaire. In addition, dietary intake, level of physical activity and palatability of the intervention diet will be registered.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Dietary treatment
Dietary treatment with healthy lunch and snack meal during working hours

Locations

Country Name City State
Denmark EFFECT, Copenhagen University Hospital at Herlev Herlev Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Leedo E, Beck AM, Astrup A, Lassen AD. The effectiveness of healthy meals at work on reaction time, mood and dietary intake: a randomised cross-over study in daytime and shift workers at an university hospital. Br J Nutr. 2017 Jul;118(2):121-129. doi: 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reaction-time 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 Dietary intake 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
Secondary Physical activity 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
Secondary Palatability of the diet eaten during working hours 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
Secondary Well-being 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
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