- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00122928
Comparison of Workplace Obesity Management Programs
Environmental Approaches for Obesity Management at Dow
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND:
More than half of all Americans are overweight or obese, and the prevalence of these risk factors has increased dramatically in the past decade. Obesity is a risk factor for several chronic illnesses, including type 2 diabetes and heart disease. The national medical cost that is attributed to obesity is estimated to be between $60 and $93 billion. Business leaders are becoming increasingly aware of the human and economic burden that poor health imposes on their workers. Many employers have invested in health promotion and disease prevention programs aimed at reducing the prevalence of obesity in the workplace through the encouragement of physical activity, maintaining a healthy diet, and improved management of health risk factors. Employers continue to seek innovative and evidence-based programs that can be implemented in the workplace to address a growing public health epidemic that also adversely affects worker productivity.
DESIGN NARRATIVE:
The primary objective of this study will be to evaluate the effect of introducing two levels of environmental programs, in addition to existing individualized programs, at reducing obesity in the workplace. Five outcomes will be evaluated: 1) body mass index and other weight-related biometric measures; 2) behavioral health risk factors; 3) weight-related health conditions; 4) health care utilization and medical expenditures; and 5) employee productivity measured in terms of reduced absenteeism and on-the-job presenteeism. The study will also include an assessment of costs and benefits of the two programs, including the medical, absenteeism, and productivity benefits, and an assessment of the impact of the programs on the worksite climate. Twelve Dow chemical companies will participate in the study. Participants will be randomly assigned to a moderate environmental program, an intensive environmental program, or a control group, which will receive individualized treatment only. The moderate program will include inexpensive environmental changes (e.g., prompts and reminders). In the high intensity program, senior managers will assist in the development of a worksite culture that is broadly supportive of improved weight and health management by employees. Annual health screening and biometrics data along with administrative medical claims, absence records, and productivity survey data will be analyzed to determine program impacts. Non-experimental statistical methods will be used to control the differences that remain across sites after randomization. The study will also produce extensive information about how employers can successfully implement environmental programs to reduce obesity at worksites.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Active employees at any of 12 participating company locations of The Dow Chemical Company
- Participants must be must be between 18 and 70 years old
Exclusion Criteria:
- The Dow Chemical Company employees located at a facility other than one of the 12 study sites
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High intensity environmental intervention
Intense intervention
|
Healthy Choices in vending machines; Healthy Choices in cafeteria; Catering (Healthy Choices in site meetings, shutdowns, OT meals, etc.); Targeted Messages: Nutrition; Site Based Rewards and Recognition - Individual Employees Weight Management Tracking Program
Walking Paths/Routes; Weight Management Tracking Program; Targeted Messages: Physical Activity; Site Based Rewards and Recognition - Individual Employees
Site Goal Setting; Work Group Alignment to Site Goals; Reporting to Senior Leadership; Leadership Training; Site Leadership, Cross Discipline Teams, Work Groups, Healthy Culture Focal Point Rewards and Recognition
|
Experimental: Moderate intensity environmental intervention
Moderate intervention
|
Healthy Choices in vending machines; Healthy Choices in cafeteria; Catering (Healthy Choices in site meetings, shutdowns, OT meals, etc.); Targeted Messages: Nutrition; Site Based Rewards and Recognition - Individual Employees Weight Management Tracking Program
Walking Paths/Routes; Weight Management Tracking Program; Targeted Messages: Physical Activity; Site Based Rewards and Recognition - Individual Employees
|
No Intervention: Individual intervention only
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of obesity
Time Frame: Measured at baseline and at the end of years 1 and 2
|
Measured at baseline and at the end of years 1 and 2
|
Weight-related risk factors
Time Frame: Measured at baseline and at the end of years 1 and 2
|
Measured at baseline and at the end of years 1 and 2
|
Overall health and well-being
Time Frame: Measured at baseline and at the end of years 1 and 2
|
Measured at baseline and at the end of years 1 and 2
|
Healthcare utilization and expenditures
Time Frame: Measured at baseline and at the end of years 1 and 2
|
Measured at baseline and at the end of years 1 and 2
|
Employee productivity measures (i.e., absenteeism and presenteeism)
Time Frame: Measured at baseline and at the end of years 1 and 2
|
Measured at baseline and at the end of years 1 and 2
|
Return on investment (measured at Year 2)
Time Frame: Measured at baseline and at the end of years 1 and 2
|
Measured at baseline and at the end of years 1 and 2
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ron Z. Goetzel, PhD, Emory University
Publications and helpful links
General Publications
- Goetzel RZ, Ozminkowski RJ, Baase CM, Billotti GM. Estimating the return-on-investment from changes in employee health risks on the Dow Chemical Company's health care costs. J Occup Environ Med. 2005 Aug;47(8):759-68. doi: 10.1097/01.jom.0000172868.05935.67.
- Pratt CA, Lemon SC, Fernandez ID, Goetzel R, Beresford SA, French SA, Stevens VJ, Vogt TM, Webber LS. Design characteristics of worksite environmental interventions for obesity prevention. Obesity (Silver Spring). 2007 Sep;15(9):2171-80. doi: 10.1038/oby.2007.258.
- Wilson MG, Goetzel RZ, Ozminkowski RJ, DeJoy DM, Della L, Roemer EC, Schneider J, Tully KJ, White JM, Baase CM. Using formative research to develop environmental and ecological interventions to address overweight and obesity. Obesity (Silver Spring). 2007 Nov;15 Suppl 1(Suppl 1):37S-47S. doi: 10.1038/oby.2007.386.
- Della LJ, DeJoy DM, Goetzel RZ, Ozminkowski RJ, Wilson MG. Assessing management support for worksite health promotion: psychometric analysis of the leading by example (LBE) instrument. Am J Health Promot. 2008 May-Jun;22(5):359-67. doi: 10.4278/ajhp.22.5.359.
- Dejoy DM, Wilson MG, Goetzel RZ, Ozminkowski RJ, Wang S, Baker KM, Bowen HM, Tully KJ. Development of the Environmental Assessment Tool (EAT) to measure organizational physical and social support for worksite obesity prevention programs. J Occup Environ Med. 2008 Feb;50(2):126-37. doi: 10.1097/JOM.0b013e318161b42a.
- Goetzel RZ, Bowen J, Ozminkowski RJ, Kassed, C, Roemer, EC, Tabrizi MJ, Short M, Wang S, Pei X, Bowen H, DeJoy DM, Wilson MG, Baker K, Tully K, White JM, Billotti GM, Baase CM (In press). Case Study: Introducing Environmental Interventions at The Dow Chemical Company Aimed at Reducing Overweight and Obesity among Workers. Book chapter in American College of Sports Medicine Worksite Health Handbook. Second Edition: Healthy Worker, Healthy Company, Pronk N (ed.) Human Kinetics.
- Goetzel RZ, Baker KM, Short ME, Pei X, Ozminkowski RJ, Wang S, Bowen JD, Roemer EC, Craun BA, Tully KJ, Baase CM, DeJoy DM, Wilson MG. First-year results of an obesity prevention program at The Dow Chemical Company. J Occup Environ Med. 2009 Feb;51(2):125-38. doi: 10.1097/JOM.0b013e3181954b03.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00009301
- R01HL079546 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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