Effect of Healthy Lunch and Snack Meal on Reaction Time and Well-being of Physicians and Nursing Staff (Go-No-Go)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Bitz, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01739569
First received: November 22, 2012
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Nutrition Intervention
Other: Dietary treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Long-term Effect of Healthy Lunch and Snack Meal on Reaction Time and Well-being: A Randomised Controlled Intervention in Physicians and Nursing Staff.

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Reaction-time [ Time Frame: week 0, week 5 and week 9 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Dietary intake [ Time Frame: Week 0, week 5, week 9 ] [ Designated as safety issue: No ]
    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

  • Physical activity [ Time Frame: Week 0, week 5, week 9 ] [ Designated as safety issue: No ]
    Differences in 24-hours physical activity measured by self-reported records during four working days using a standardized physical activity record form.

  • Palatability of the diet eaten during working hours [ Time Frame: Week 0, week 5 and week 9 ] [ Designated as safety issue: No ]
    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).

  • Well-being [ Time Frame: Week 0, week 5 and week 9 ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary treatment
Dietary treatment with healthy lunch and snack meal during working hours
Other: Dietary treatment
Dietary treatment with healthy lunch and snack meal during working hours
No Intervention: Habitual meals
Dietary treatment with habitual diet

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739569

Locations
Denmark
EFFECT, Copenhagen University Hospital at Herlev
Herlev, Copenhagen, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Christian Bitz, Cand Scient Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Christian Bitz, Head of Research, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01739569     History of Changes
Other Study ID Numbers: EFFECT.A01.2012
Study First Received: November 22, 2012
Last Updated: January 22, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital at Herlev:
Diet treatment
Mental Health
Reaction time
State of moods
Working hours
Medical Hospital Staff

Additional relevant MeSH terms:
Food Habits
Habits

ClinicalTrials.gov processed this record on July 22, 2014