Environmental Intervention for Weight Gain Prevention (HealthWorks)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weight gain prevention
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring obesity, obesity prevention, worksite, environment, intervention
Eligibility 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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Worksite Environmental Intervention
No-contact control
Arm Description
Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
Outcomes
Primary Outcome Measures
Change in Body Mass Index (BMI)
Assessed in kilograms per meter squared.
Secondary Outcome Measures
Full Information
NCT ID
NCT00708461
First Posted
June 27, 2008
Last Updated
October 30, 2019
Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00708461
Brief Title
Environmental Intervention for Weight Gain Prevention
Acronym
HealthWorks
Official Title
Environmental Intervention for Weight Gain Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, obesity prevention, worksite, environment, intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1747 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Worksite Environmental Intervention
Arm Type
Experimental
Arm Description
Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
Arm Title
No-contact control
Arm Type
No Intervention
Arm Description
No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
Intervention Type
Behavioral
Intervention Name(s)
weight gain prevention
Other Intervention Name(s)
worksite intervention, obesity prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
Assessed in kilograms per meter squared.
Time Frame
Baseline to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Jeffery, PhD
Organizational Affiliation
University of Minnesota, Division of Epidemiology and Community Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23108493
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.
Results Reference
result
PubMed Identifier
22340088
Citation
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. 2012 Feb 16;9:14. doi: 10.1186/1479-5868-9-14.
Results Reference
result
PubMed Identifier
21952267
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. doi: 10.1123/jpah.9.6.849. Epub 2011 Jul 29.
Results Reference
result
PubMed Identifier
21732212
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.
Results Reference
result
PubMed Identifier
23979097
Citation
Graham DJ, Linde JA, Cousins JM, Jeffery RW. Environmental modifications and 2-year measured and self-reported stair-use: a worksite randomized trial. J Prim Prev. 2013 Dec;34(6):413-22. doi: 10.1007/s10935-013-0323-2.
Results Reference
derived
Links:
URL
http://www.ahc.umn.edu/opc/research/OPC_Currently_Funded/home.html
Description
HealthWorks is a study housed in the University of Minnesota Obesity Prevention Center.
Learn more about this trial
Environmental Intervention for Weight Gain Prevention
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