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The Lifestyle moDIfCation Study (LUDIC)

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ClinicalTrials.gov Identifier: NCT01574040
Recruitment Status : Unknown
Verified April 2012 by dr.Frank L.J. Visseren, UMC Utrecht.
Recruitment status was:  Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
dr.Frank L.J. Visseren, UMC Utrecht

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Before-and-after Study to Evaluate Effects of Low-cost Interventions for Promoting Healthy Lifestyle Modifications
Study Start Date : February 2012
Estimated Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Experimental: Staff (and visitors) of the University Medical Centre Utrecht
This is a dynamic study population
Behavioral: Promotion of stair climbing
Application of labels on all UMC elevator doors stating: " If you take the stairs, you will burn 11 times more calories."

Behavioral: 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."

Behavioral: Promotion of a low-fat alternative for the butter croissants
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."

Behavioral: Exchange of the basket positions of butter and margarine in the UMC staff restaurant between convenient and harder to reach locations
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.




Primary Outcome Measures :
  1. Number of passages through each part of the stair cases [ Time Frame: 2 weeks (including weekend days) ]
    Measured by wireless infrared interruption counters

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Dynamic population of staff and visitors of the University Medical Center Utrecht, The Netherlands

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574040


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: dr.Frank L.J. Visseren, Professor of Vascular Medicine, Internist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01574040    
Other Study ID Numbers: Vasc-UMCU-14B
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by dr.Frank L.J. Visseren, UMC Utrecht:
Lifestyle
Lifestyle modification
Behavior
Primary prevention
Healthy staff and visitors of an Academic Hospital