Nutrition InterventionNCT01739569
Effect of Healthy Lunch and Snack Meal on Reaction Time and Well-being of Physicians and Nursing Staff (Go-No-Go)
A study testing Dietary treatment in people with Nutrition Intervention, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Intervention
- What is being tested?
- Dietary treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
EFFECT, Copenhagen University Hospital at Herlev
Herlev, Copenhagen, 2730
About this study
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.
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.
Read the 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.
- Conditions
- Nutrition Intervention
- Being tested
- Dietary treatment
- Keywords
- Diet treatment, Mental Health, Reaction time, State of moods, Working hours, Medical Hospital Staff
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary treatmentOther
Dietary treatment with healthy lunch and snack meal during working hours
| Study group | Role | What they receive |
|---|---|---|
| Dietary treatment | Experimental | Dietary treatment with healthy lunch and snack meal during working hours Receives: Other: Dietary treatment |
| Habitual meals | No intervention | Dietary treatment with habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 0, week 5 and week 9
Secondary outcomes (4)
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
Measured: Week 0, week 5, week 9
Physical activity
Differences in 24-hours physical activity measured by self-reported records during four working days using a standardized physical activity record form.
Measured: Week 0, week 5, week 9
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).
Measured: Week 0, week 5 and week 9
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.
Measured: Week 0, week 5 and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Bitz, Copenhagen University Hospital at Herlev
- Investigators
- Christian Bitz, Cand Scient, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739569
- Sponsor's protocol ID
- EFFECT.A01.2012
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2012
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28820084
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01739569
- Acronym / sponsor ID
- EFFECT.A01.2012
- Conditions
- Nutrition Intervention
- Keywords
- Diet treatment, Mental Health, Reaction time, State of moods, Working hours, Medical Hospital Staff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary treatment | Experimental | Other: Dietary treatmentDietary treatment with healthy lunch and snack meal during working hours |
| Habitual meals | No intervention | –Dietary treatment with habitual diet |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary treatmentDietary treatment with healthy lunch and snack meal during working hours | Other | Dietary treatment |
Primary outcome
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.
4 secondary outcomes
Dietary intake
Time frame: Week 0, week 5, week 9
Physical activity
Time frame: Week 0, week 5, week 9
Palatability of the diet eaten during working hours
Time frame: Week 0, week 5 and week 9
Well-being
Time frame: Week 0, week 5 and week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Results publication: PubMed 28820084Leedo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Bitz, Cand Scient principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary treatment in people with Nutrition Intervention, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction-time (time frame: week 0, week 5 and week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.