Clinical trial NCT01574040: The Lifestyle moDIfCation Study
Official title: A Before-and-after Study to Evaluate Effects of Low-cost Interventions for Promoting Healthy Lifestyle Modifications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Lifestyle
Lifestyle modification
Behavior
Primary prevention
Healthy staff and visitors of an Academic Hospital
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 11000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of passages through each part of the stair cases
timeFrame: 2 weeks (including weekend days)
measure: Number of low-salt cream soup and normal clear soup cups sold in the hospital restaurant and ratio between them
timeFrame: 2 weeks (excluding weekend days)
measure: Number of low-fat and normal croissants sold in the hospital restaurant and the ratio between them
timeFrame: 2 weeks (excluding weekend days)
measure: Number of low-fat margarine servings and butter servings sold in the hospital restaurant and the ratio between them
timeFrame: 2 weeks (excluding weekend days)
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
citation: 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.