ObesityNCT00122928
Comparison of Workplace Obesity Management Programs
A study testing Diet, Exercise and Environmental Obesity Program - Healthy Culture in people with Obesity and Cardiovascular Diseases, run by Emory University.
Trial summary
The purpose of this study is to design and demonstrate the feasibility of implementing moderate and intensive environmental obesity prevention programs at major worksites. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Diet, Exercise and Environmental Obesity Program - Healthy Culture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,124 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The Dow Chemical Company employees located at a facility other than one of the 12 study sites
About this study
Official title: Environmental Approaches for Obesity Management at Dow
The purpose of this study is to design and demonstrate the feasibility of implementing moderate and intensive environmental obesity prevention programs at major worksites.
Read the 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.
- Conditions
- Obesity, Cardiovascular Diseases, Heart Diseases
- Being tested
- Diet, Exercise, Environmental Obesity Program - Healthy Culture
- Keywords
- Worksite, Workplace, Return on Investment, Financial Impact
- Medical subject headings
- Obesity, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
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
ExerciseBehavioural
Walking Paths/Routes; Weight Management Tracking Program; Targeted Messages: Physical Activity; Site Based Rewards and Recognition - Individual Employees
Environmental Obesity Program - Healthy CultureBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| High intensity environmental intervention | Experimental | Intense intervention Receives: Behavioral: Diet; Behavioral: Exercise; Behavioral: Environmental Obesity Program - Healthy Culture |
| Moderate intensity environmental intervention | Experimental | Moderate intervention Receives: Behavioral: Diet; Behavioral: Exercise |
| Individual intervention only | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of obesity
Measured: Measured at baseline and at the end of years 1 and 2
Weight-related risk factors
Measured: Measured at baseline and at the end of years 1 and 2
Overall health and well-being
Measured: Measured at baseline and at the end of years 1 and 2
Healthcare utilization and expenditures
Measured: Measured at baseline and at the end of years 1 and 2
Employee productivity measures (i.e., absenteeism and presenteeism)
Measured: Measured at baseline and at the end of years 1 and 2
Return on investment (measured at Year 2)
Measured: Measured at baseline and at the end of years 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startOct 2004
- Primary completionMar 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ron Goetzel, Emory University
- Investigators
- Ron Z. Goetzel, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122928
- Sponsor's protocol ID
- IRB00009301
- Other IDs
- R01HL079546
- Status last verified
- Nov 2013
- First submitted
- 20 Jul 2005
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16093925Pratt 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.
PubMed 17890484Wilson 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.
PubMed 18073340Della 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.
PubMed 18517097Dejoy 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.
PubMed 18301169Goetzel 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.
PubMed 19209033
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Approaches for Obesity Management at Dow
- ClinicalTrials.gov ID
- NCT00122928
- Acronym / sponsor ID
- IRB00009301
- Conditions
- Obesity, Cardiovascular Diseases, Heart Diseases
- Keywords
- Worksite, Workplace, Return on Investment, Financial Impact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,124 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to design and demonstrate the feasibility of implementing moderate and intensive environmental obesity prevention programs at major worksites.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity environmental intervention | Experimental | Behavioral: Diet, Behavioral: Exercise, Behavioral: Environmental Obesity Program - Healthy CultureIntense intervention |
| Moderate intensity environmental intervention | Experimental | Behavioral: Diet, Behavioral: ExerciseModerate intervention |
| Individual intervention only | No intervention | –Control |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- The Dow Chemical Company employees located at a facility other than one of the 12 study sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietHealthy 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 | Behavioural | High intensity environmental intervention, Moderate intensity environmental intervention |
| ExerciseWalking Paths/Routes; Weight Management Tracking Program; Targeted Messages: Physical Activity; Site Based Rewards and Recognition - Individual Employees | Behavioural | High intensity environmental intervention, Moderate intensity environmental intervention |
| Environmental Obesity Program - Healthy CultureSite 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 | Behavioural | High intensity environmental intervention |
Primary outcome
Prevalence of obesity
Time frame: 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
Overall health and well-being
Time frame: 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
Employee productivity measures (i.e., absenteeism and presenteeism)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
- Background: PubMed 16093925Goetzel 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.
- Background: PubMed 17890484Pratt 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.
- Background: PubMed 18073340Wilson 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.
- Background: PubMed 18517097Della 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.
- Background: PubMed 18301169Dejoy 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.
- BackgroundGoetzel 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.
- Background: PubMed 19209033Goetzel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Z. Goetzel, PhD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Exercise and Environmental Obesity Program - Healthy Culture in people with Obesity and Cardiovascular Diseases, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of obesity (time frame: Measured at baseline and at the end of years 1 and 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122928, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.