HealthyLUDICNCT01574040
The Lifestyle moDIfCation Study
A study testing Promotion of stair climbing, Promotion of a low-salt soup alternative for the 'soup of the day' and Promotion of a low-fat alternative for the butter croissants in people with Healthy, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Rationale: Lifestyle modifications, such as increasing physical exercise and reducing dietary salt and saturated fat intake contribute to prevention of cardiovascular morbidity and mortality. Relevant improvements can already be achieved by small adaptations in everyday life. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Promotion of stair climbing, Promotion of a low-salt soup alternative for the 'soup of the day' and Promotion of a low-fat alternative for the butter croissants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Dynamic population of staff and visitors of the University Medical Center Utrecht, The Netherlands
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Before-and-after Study to Evaluate Effects of Low-cost Interventions for Promoting Healthy Lifestyle Modifications
Rationale: Lifestyle modifications, such as increasing physical exercise and reducing dietary salt and saturated fat intake contribute to prevention of cardiovascular morbidity and mortality. Relevant improvements can already be achieved by small adaptations in everyday life. It is unclear whether simple low-cost interventions in the working environment can promote such healthy lifestyle adaptations.
Objective: To study the effect of low-cost interventions for promoting healthy lifestyle modifications.
Read more
Study design: Before-and-after intervention study. The study period will be subdivided in four parts of 2 weeks each: a run-in period, a before-measurement period, an intervention-period, and an after measurement period.
Study population: Staff and visitors of the University Medical Center Utrecht.
Study interventions:
- Promotion of stair climbing.
- Promotion of a low-salt soup alternative for the 'soup of the day'.
- Promotion of a low-fat alternative for the butter croissants.
- Exchange of the basket positions of butter and margarine between convenient and harder to reach locations.
Outcome measures:
- Number of passages through each part of the stair cases.
- Number of low-salt cream soup and normal clear soup cups sold in the hospital restaurant and ratio between them.
- Number of low-fat and normal croissants sold in the hospital restaurant and the ratio between them.
- Number of low-fat margarine servings and butter servings sold in the hospital restaurant and the ratio between them.
Read the detailed description
Detailed description of the study periods:
- Run-in period: during the first 2 weeks of the study (day 1 until day 14) the baseline situation should be established and remain stable. This period is meant for study personnel to get acquainted with the study procedures.
- Before-measurement: during weeks 3 and 4 (day 15 until day 28) the measurements will start to record all endpoints and additional parameters during the baseline situation.
- Intervention-period: during weeks 5 and 6 (day 29 until day 42) the measurements will continue while the interventions are carried out.
- After measurement: during weeks 7 and 8 (day 43 until day 56) the measurements will continue while the interventions have ended and the baseline situation is restored.
- Conditions
- Healthy
- Being tested
- Promotion of stair climbing, Promotion of a low-salt soup alternative for the 'soup of the day', Promotion of a low-fat alternative for the butter croissants, Exchange of the basket positions of butter and margarine in the UMC staff restaurant between convenient and harder to reach locations
- Keywords
- Lifestyle, Lifestyle modification, Behavior, Primary prevention, Healthy staff and visitors of an Academic Hospital
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of stair climbingBehavioural
Application of labels on all UMC elevator doors stating: " If you take the stairs, you will burn 11 times more calories."
Promotion of a low-salt soup alternative for the 'soup of the day'Behavioural
Promotion of a low-salt soup alternative for the 'soup of the day' in the UMC staff restaurant, using a sign stating: "The cream soup contains 30% less salt and contributes to a healthy blood pressure."
Promotion of a low-fat alternative for the butter croissantsBehavioural
Promotion of a low-fat alternative for the butter croissants in the UMC staff restaurant, using a sign stating: "This croissant contains 30% fewer saturated (unhealthy) fatty acids."
Exchange of the basket positions of butter and margarine in the UMC staff restaurant between convenient and harder to reach locationsBehavioural
Exchange of the basket positions of butter and margarine in the UMC staff restaurant. In the usual (baseline) situation butter is positioned in the fridge and, therefore, less visible and harder to reach. Margarine is positioned on several convenient locations throughout the restaurant. During the two weeks intervention period these positions will be interchanged.
| Study group | Role | What they receive |
|---|---|---|
| Staff (and visitors) of the University Medical Centre Utrecht | Experimental | This is a dynamic study population Receives: Behavioral: Promotion of stair climbing; Behavioral: Promotion of a low-salt soup alternative for the 'soup of the day'; Behavioral: Promotion of a low-fat alternative for the butter croissants; Behavioral: Exchange of the basket positions of butter and margarine in the UMC staff restaurant between convenient and harder to reach locations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of passages through each part of the stair cases
Measured by wireless infrared interruption counters
Measured: 2 weeks (including weekend days)
Number of low-salt cream soup and normal clear soup cups sold in the hospital restaurant and ratio between them
Assessed by the pay desk computer system administration
Measured: 2 weeks (excluding weekend days)
Number of low-fat and normal croissants sold in the hospital restaurant and the ratio between them
Number of croissants sold will be registered on daily work sheets by the restaurant personnel
Measured: 2 weeks (excluding weekend days)
Number of low-fat margarine servings and butter servings sold in the hospital restaurant and the ratio between them
Assessed by the pay desk computer system administration
Measured: 2 weeks (excluding weekend days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012 (estimated)
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 HealthyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr.Frank L.J. Visseren, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574040
- Sponsor's protocol ID
- Vasc-UMCU-14B
- Acronym
- LUDIC
- Status last verified
- Apr 2012
- First submitted
- 9 Feb 2012
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dorresteijn JA, van der Graaf Y, Zheng K, Spiering W, Visseren FL. The daily 10 kcal expenditure deficit: a before-and-after study on low-cost interventions in the work environment. BMJ Open. 2013 Jan 24;3(1):e002125. doi: 10.1136/bmjopen-2012-002125.
PubMed 23355669
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Before-and-after Study to Evaluate Effects of Low-cost Interventions for Promoting Healthy Lifestyle Modifications
- ClinicalTrials.gov ID
- NCT01574040
- Acronym / sponsor ID
- LUDIC / Vasc-UMCU-14B
- Conditions
- Healthy
- Keywords
- Lifestyle, Lifestyle modification, Behavior, Primary prevention, Healthy staff and visitors of an Academic Hospital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (estimated)
- First posted
- 10 Apr 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.
Rationale: Lifestyle modifications, such as increasing physical exercise and reducing dietary salt and saturated fat intake contribute to prevention of cardiovascular morbidity and mortality. Relevant improvements can already be achieved by small adaptations in everyday life. It is unclear whether simple low-cost interventions in the working environment can promote such healthy lifestyle adaptations.
Objective: To study the effect of low-cost interventions for promoting healthy lifestyle modifications.
Study design: Before-and-after intervention study. The study period will be subdivided in four parts of 2 weeks each: a run-in period, a before-measurement period, an intervention-period, and an after measurement period.
Study population: Staff and visitors of the University Medical Center Utrecht.
Study interventions:
- Promotion of stair climbing.
- Promotion of a low-salt soup alternative for the 'soup of the day'.
- Promotion of a low-fat alternative for the butter croissants.
- Exchange of the basket positions of butter and margarine between convenient and harder to reach locations.
Outcome measures:
- Number of passages through each part of the stair cases.
- Number of low-salt cream soup and normal clear soup cups sold in the hospital restaurant and ratio between them.
- Number of low-fat and normal croissants sold in the hospital restaurant and the ratio between them.
- Number of low-fat margarine servings and butter servings sold in the hospital restaurant and the ratio between them.
Detailed description
Detailed description of the study periods:
- Run-in period: during the first 2 weeks of the study (day 1 until day 14) the baseline situation should be established and remain stable. This period is meant for study personnel to get acquainted with the study procedures.
- Before-measurement: during weeks 3 and 4 (day 15 until day 28) the measurements will start to record all endpoints and additional parameters during the baseline situation.
- Intervention-period: during weeks 5 and 6 (day 29 until day 42) the measurements will continue while the interventions are carried out.
- After measurement: during weeks 7 and 8 (day 43 until day 56) the measurements will continue while the interventions have ended and the baseline situation is restored.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staff (and visitors) of the University Medical Centre Utrecht | Experimental | Behavioral: Promotion of stair climbing, Behavioral: Promotion of a low-salt soup alternative for the 'soup of the day', Behavioral: Promotion of a low-fat alternative for the butter croissants, Behavioral: Exchange of the basket positions of butter and margarine in the UMC staff restaurant between convenient and harder to reach locationsThis is a dynamic study population |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Promotion of stair climbingApplication of labels on all UMC elevator doors stating: " If you take the stairs, you will burn 11 times more calories." | Behavioural | Staff (and visitors) of the University Medical Centre Utrecht |
| Promotion of a low-salt soup alternative for the 'soup of the day'Promotion of a low-salt soup alternative for the 'soup of the day' in the UMC staff restaurant, using a sign stating: "The cream soup contains 30% less salt and contributes to a healthy blood pressure." | Behavioural | Staff (and visitors) of the University Medical Centre Utrecht |
| Promotion of a low-fat alternative for the butter croissantsPromotion of a low-fat alternative for the butter croissants in the UMC staff restaurant, using a sign stating: "This croissant contains 30% fewer saturated (unhealthy) fatty acids." | Behavioural | Staff (and visitors) of the University Medical Centre Utrecht |
| Exchange of the basket positions of butter and margarine in the UMC staff restaurant between convenient and harder to reach locationsExchange of the basket positions of butter and margarine in the UMC staff restaurant. In the usual (baseline) situation butter is positioned in the fridge and, therefore, less visible and harder to reach. Margarine is positioned on several convenient locations throughout the restaurant. During the two weeks intervention period these positions will be interchanged. | Behavioural | Staff (and visitors) of the University Medical Centre Utrecht |
Primary outcome
Number of passages through each part of the stair cases
Time frame: 2 weeks (including weekend days)
Measured by wireless infrared interruption counters
Number of low-salt cream soup and normal clear soup cups sold in the hospital restaurant and ratio between them
Time frame: 2 weeks (excluding weekend days)
Assessed by the pay desk computer system administration
Number of low-fat and normal croissants sold in the hospital restaurant and the ratio between them
Time frame: 2 weeks (excluding weekend days)
Number of croissants sold will be registered on daily work sheets by the restaurant personnel
Number of low-fat margarine servings and butter servings sold in the hospital restaurant and the ratio between them
Time frame: 2 weeks (excluding weekend days)
Assessed by the pay desk computer system administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
- Derived from this study: PubMed 23355669Dorresteijn JA, van der Graaf Y, Zheng K, Spiering W, Visseren FL. The daily 10 kcal expenditure deficit: a before-and-after study on low-cost interventions in the work environment. BMJ Open. 2013 Jan 24;3(1):e002125. doi: 10.1136/bmjopen-2012-002125.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of stair climbing, Promotion of a low-salt soup alternative for the 'soup of the day' and Promotion of a low-fat alternative for the butter croissants in people with Healthy, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2012. 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 Netherlands. 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?
Results are not available in the source record.
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?
Number of passages through each part of the stair cases (time frame: 2 weeks (including weekend days)). The study lists 4 primary outcomes in all. 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 NCT01574040, 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 10 Apr 2012.