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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00708461
Other study ID # 0408S62609
Secondary ID 5R01DK067362
Status Completed
Phase N/A
First received
Last updated
Start date January 2006
Est. completion date March 2010

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 primary aim of this research is to evaluate the efficacy of a multicomponent worksite-based, environmental intervention in reducing weight increase and obesity over time in working adults.


Description:

This study is a randomized trial designed to evaluate the effectiveness of a multi-component worksite intervention with strong environmental components to prevent weight gain. Six worksites will be randomized to either an intervention or a no-treatment control group. The intervention will be comprised of 1) changing the availability, portion sizes, and prices of foods and beverages sold to employees in their worksites in ways that encourage healthier food choices; 2) increasing the availability of physical activity opportunities at the worksite by implementing walking programs and increasing stairwell access and attractiveness; 3) placing scales in the work environment to encourage body weight monitoring and to enable workers to set goals for their weight; and 4) to provide educational materials to all employees to make them aware of the environmental intervention and of behavioral practices likely to be effective in preventing weight gain. The intervention will be implemented for a 2-year period in each intervention site. Effectiveness will be evaluated by assessing body weight, eating behavior and physical activity in a cohort of employees in both control and intervention sites at baseline and again 2 years later. Weight trends in these populations will also be compared to data from national and state-level annual surveys of weight in representative population samples. Data will be collected on the effects of specific intervention components via aggregate measures of food choice and physical activity.


Recruitment information / eligibility

Status Completed
Enrollment 1747
Est. completion date March 2010
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- age 18 or older

- generally in good health

- part- or full-time employee in one of the participating worksites

Exclusion Criteria:

- work on site <50% of the time

- work second or third shift

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
weight gain prevention
Changes in the food environment that increase the availability of healthy foods and beverages, reduce food and beverage portion sizes, reduce prices on healthy food items, and increase prices on less healthy food items. Changes in the activity environment that increase cues and incentives for walking at work and at home, using stairs, and to increase exposure of employees to information about active recreational opportunities at work and at home. Changes to the environment to increase cues and incentives for regular weight monitoring by providing scales at convenient locations. Changes in the informational environment that increase frequency of exposure of the employee population to accurate information about healthy food and activity choices.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Linde JA, Nygaard KE, MacLehose RF, Mitchell NR, Harnack LJ, Cousins JM, Graham DJ, Jeffery RW. HealthWorks: results of a multi-component group-randomized worksite environmental intervention trial for weight gain prevention. Int J Behav Nutr Phys Act. 201 — View Citation

VanWormer JJ, Linde JA, Harnack LJ, Stovitz SD, Jeffery RW. Is baseline physical activity a determinant of participation in worksite walking clubs? Data from the HealthWorks Trial. J Phys Act Health. 2012 Aug;9(6):849-56. Epub 2011 Jul 29. — View Citation

VanWormer JJ, Linde JA, Harnack LJ, Stovitz SD, Jeffery RW. Self-weighing frequency is associated with weight gain prevention over 2 years among working adults. Int J Behav Med. 2012 Sep;19(3):351-8. doi: 10.1007/s12529-011-9178-1. — View Citation

VanWormer JJ, Linde JA, Harnack LJ, Stovitz SD, Jeffery RW. Weight change and workplace absenteeism in the HealthWorks study. Obes Facts. 2012;5(5):745-52. doi: 10.1159/000345119. Epub 2012 Oct 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Body Mass Index (BMI) Assessed in kilograms per meter squared. Baseline to 24 months
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