The Lifestyle moDIfCation Study

NCT ID: NCT01574040

Last Updated: 2012-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 11000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Staff (and visitors) of the University Medical Centre Utrecht

This is a dynamic study population

Group Type: EXPERIMENTAL

Promotion of stair climbing

Intervention Type: BEHAVIORAL

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'

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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."

Intervention Type: 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."

Intervention Type: 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."

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

dr.Frank L.J. Visseren

Professor of Vascular Medicine, Internist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center Utrecht

Utrecht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 23355669 (View on PubMed)

Other Identifiers

Vasc-UMCU-14B

Identifier Type: -

Identifier Source: org_study_id