We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Environmental Intervention for Weight Gain Prevention (HealthWorks)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00708461
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : July 18, 2013
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: weight gain prevention Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1747 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Environmental Intervention for Weight Gain Prevention
Study Start Date : January 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Worksite Environmental Intervention
Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
Behavioral: weight gain prevention
  1. 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.
  2. 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.
  3. Changes to the environment to increase cues and incentives for regular weight monitoring by providing scales at convenient locations.
  4. Changes in the informational environment that increase frequency of exposure of the employee population to accurate information about healthy food and activity choices.
Other Names:
  • worksite intervention
  • obesity prevention

No Intervention: No-contact control
No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.



Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: Baseline to 24 months ]
    Assessed in kilograms per meter squared.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708461


Locations
Layout table for location information
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Robert W Jeffery, PhD University of Minnesota, Division of Epidemiology and Community Health
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00708461    
Other Study ID Numbers: 0408S62609
5R01DK067362 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2008    Key Record Dates
Results First Posted: July 18, 2013
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by University of Minnesota:
obesity
obesity prevention
worksite
environment
intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Weight Gain
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Body Weight Changes