The Lifestyle moDIfCation Study (LUDIC)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 11000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • University Medical Center Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Dynamic population of staff and visitors of the University Medical Center Utrecht, The Netherlands

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of passages through each part of the stair cases	Measured by wireless infrared interruption counters	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	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	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	2 weeks (excluding weekend days)

Collaborators and Investigators

• Sponsor: UMC Utrecht

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: February 9, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): April 10, 2012
• Last Update Submitted That Met QC Criteria: April 5, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Behavior; Primary prevention; Lifestyle modification; Lifestyle; Healthy staff and visitors of an Academic Hospital
• Other Study ID Numbers: Vasc-UMCU-14B