The Lifestyle moDIfCation Study

Healthy Clinical Trial

— LUDIC  

Official title:

A Before-and-after Study to Evaluate Effects of Low-cost Interventions for Promoting Healthy Lifestyle Modifications

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01574040
• Other study ID #: Vasc-UMCU-14B
• Status: Active, not recruiting
• Phase: N/A
• First received: February 9, 2012
• Last updated: April 5, 2012
• Start date: February 2012

Study information

• Verified date: April 2012
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11000
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

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."
• 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."
• 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."
• 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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of passages through each part of the stair cases	Measured by wireless infrared interruption counters	2 weeks (including weekend days)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No