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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00122993
Other study ID # 0409S63606
Secondary ID R01HL079478
Status Completed
Phase N/A
First received
Last updated
Start date September 2004
Est. completion date April 2008

Study information

Verified date October 2019
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to implement and evaluate a two-year multi-component environmental intervention to prevent weight gain among city bus drivers at four bus garages.

It is hypothesized that transit employees in the intervention garages will gain less weight compared to the transit employees in the control garages.


Description:

BACKGROUND:

Environmental influences that support less healthful food choices and sedentary behaviors have contributed to the epidemic increase in overweight and obesity among U.S. adults. Worksite settings are an effective channel through which to reach adults with interventions designed to prevent excess weight gain and obesity.

DESIGN NARRATIVE:

This study will implement and evaluate a multi-component environmental intervention to prevent excess weight gain among 1200 bus drivers working in four garages in a major metropolitan area. Four garages will be randomized to the intervention or control group for a two-year period. The environmental interventions are based on a social ecological framework and target four worksite environmental areas: 1) food availability and incentives; 2) physical activity opportunities and incentives; 3) the social environment; and 4) media/promotion related to health food choices, physical activity, and body weight.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date April 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Employed as a bus driver

Exclusion criteria:

- Not employed as a bus operator at one of the four participating garages

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthful eating and food choices behavior change programs and changes in worksite food availability and prices
Food choices and eating behavior programs and environmental changes will be implemented for 18 months in intervention garages.
Physical Activity
Physical activity programs are offered at the intervention garages for an 18 month period.
Environment
Changes in the food and physical activity environment are made for an 18 month period in intervention garages. These include improving the healthfulness of the foods available in vending machines, and improving the fitness rooms at the garages.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in body weight Measured at Year 2
Secondary Changes in energy intake and physical activity Measured at Year 2
Secondary Health claims cost Measured at Year 2
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