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Clinical Trial Summary

H1: The increase in body mass index between baseline and two year follow-up among intervention worksites will be lower than that among control worksites, such that the differential change will be negative on average.


Clinical Trial Description

Our overall objective is to develop and evaluate an intervention that will maintain or decrease body mass index; specifically, we will recruit and randomize 30 worksites to a two year intervention in which we will:

- Influence the worksite environment, including policies and procedures, by increasing worksite access to healthy foods and physical activity opportunities

- Promote individual behavior change, through increasing awareness of energy balance; building a physical activity intervention that will promote increased levels of energy expenditure through the combination of increased daily physical activity and regular, structured exercise; and building a dietary intervention that will promote decreased calorie intake.

Our primary aim is to:

1) Evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites.

Our secondary aims are to:

1. Assess changes in worksite environment in access to healthy foods and physical activity opportunities attributable to the intervention

2. Assess changes in individual level physical activity and energy intake attributable to the intervention

3. Assess the changes in sequalae of weight loss including biomarkers of metabolic effects, and weight loss quality of life and symptom measures; and

4. Estimate the cost-effectiveness of the intervention in controlling weight. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00715130
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact
Status Completed
Phase N/A
Start date September 2005
Completion date August 2010

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