NCT01739569

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2012

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

November 22, 2012

Last Update Submit

December 20, 2022

Conditions

Nutrition Intervention

Keywords

Diet treatmentMental HealthReaction timeState of moodsWorking hoursMedical Hospital Staff

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Dietary intake

    Week 0, week 5, week 9

  • Physical activity

    Week 0, week 5, week 9

  • Palatability of the diet eaten during working hours

    Week 0, week 5 and week 9

  • Well-being

    Week 0, week 5 and week 9

Study Arms (2)

Dietary treatment

EXPERIMENTAL

Dietary treatment with healthy lunch and snack meal during working hours

Other: Dietary treatment

Habitual meals

NO INTERVENTION

Dietary treatment with habitual diet

Interventions

Dietary treatmentOTHER

Dietary treatment with healthy lunch and snack meal during working hours

Dietary treatment

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EFFECT, Copenhagen University Hospital at Herlev

Herlev, Copenhagen, 2730, Denmark

Location

Related 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: 10.1017/S000711451700191X.

    PMID: 28820084RESULT

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Christian Bitz, Cand Scient

    Copenhagen University Hospital at Herlev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research

Study Record Dates

First Submitted

November 22, 2012

First Posted

December 3, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations

DK(1)