ObesityNCT00123513
Workplace-Sponsored Program to Reduce Obesity
A study testing Diet, Exercise and Environment in people with Obesity and Cardiovascular Diseases, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to design a comprehensive nutrition and physical activity strategy to gain a broad understanding of the social and cultural role of food and physical activity among workers. Perspectives on innovative interventions that are socially feasible and culturally acceptable will also be obtained. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Diseases
- What is being tested?
- Diet, Exercise and Environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,938 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Full-time employees in good health
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Images of a Healthy Worksite-Preventing Weight Gain in the Workplace
The purpose of this study is to design a comprehensive nutrition and physical activity strategy to gain a broad understanding of the social and cultural role of food and physical activity among workers. Perspectives on innovative interventions that are socially feasible and culturally acceptable will also be obtained. Health lifestyle promotion interventions addressing portion control, healthy nutrition, and increasing physical activity will be tested.
Read the detailed description
BACKGROUND:
Broad, population-based approaches are needed to stop or reverse the rise in obesity prevalence. According to the World Health Organization, obesity prevention can be achieved by promoting a healthy diet and a physically active lifestyle. A partnership with the Eastman Kodak Company has been developed to test a worksite intervention for obesity prevention in Rochester, New York.
DESIGN NARRATIVE:
The overall goal of this study is to design a comprehensive nutrition and physical activity strategy based on participatory research to promote a healthy lifestyle and to stop the shift of the population body mass index (BMI) curve to the right. Six pairs of worksites will be randomized to either an intervention or control group. Two cross-sectional samples of employees within each worksite will be measured at baseline and at the end of the intervention.
- Conditions
- Obesity, Cardiovascular Diseases
- Being tested
- Diet, Exercise, Environment
- Medical subject headings
- Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
Also called Obesogenic environment
Environmental changes in the food and physical activity environment. Cafeteria and vending machine changes, food brought from home, walking routes, and awareness building.
ExerciseBehavioural
Increase routing physical activity, walking routes, stairs intervention, etc.
EnvironmentBehavioural
Cafeteria and vending machine changes and identification of opportunities of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Worksite intervention for obesity prevention Receives: Behavioral: Diet; Behavioral: Exercise; Behavioral: Environment |
| 2 | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: Measured at baseline and Year 2
Secondary outcomes (2)
Number of serving of fruits and vegetables
Measured: Measured at baseline and Year 2
Number of steps a day
Measured: Measured at baseline and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 3,938 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Diana Fernandez, University of Rochester
- Investigators
- Isabel D. Fernandez, MD, MPH, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123513
- Sponsor's protocol ID
- 196
- Other IDs
- R01HL079511
- Status last verified
- Jun 2012
- First submitted
- 21 Jul 2005
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Images of a Healthy Worksite-Preventing Weight Gain in the Workplace
- ClinicalTrials.gov ID
- NCT00123513
- Acronym / sponsor ID
- 196
- Conditions
- Obesity, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,938 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 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 a comprehensive nutrition and physical activity strategy to gain a broad understanding of the social and cultural role of food and physical activity among workers. Perspectives on innovative interventions that are socially feasible and culturally acceptable will also be obtained. Health lifestyle promotion interventions addressing portion control, healthy nutrition, and increasing physical activity will be tested.
Detailed description
BACKGROUND:
Broad, population-based approaches are needed to stop or reverse the rise in obesity prevalence. According to the World Health Organization, obesity prevention can be achieved by promoting a healthy diet and a physically active lifestyle. A partnership with the Eastman Kodak Company has been developed to test a worksite intervention for obesity prevention in Rochester, New York.
DESIGN NARRATIVE:
The overall goal of this study is to design a comprehensive nutrition and physical activity strategy based on participatory research to promote a healthy lifestyle and to stop the shift of the population body mass index (BMI) curve to the right. Six pairs of worksites will be randomized to either an intervention or control group. Two cross-sectional samples of employees within each worksite will be measured at baseline and at the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Diet, Behavioral: Exercise, Behavioral: EnvironmentWorksite intervention for obesity prevention |
| 2 | No intervention | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Full-time employees in good health
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DietAlso: Obesogenic environmentEnvironmental changes in the food and physical activity environment. Cafeteria and vending machine changes, food brought from home, walking routes, and awareness building. | Behavioural | 1 |
| ExerciseIncrease routing physical activity, walking routes, stairs intervention, etc. | Behavioural | 1 |
| EnvironmentCafeteria and vending machine changes and identification of opportunities of physical activity. | Behavioural | 1 |
Primary outcome
BMI
Time frame: Measured at baseline and Year 2
2 secondary outcomes
Number of serving of fruits and vegetables
Time frame: Measured at baseline and Year 2
Number of steps a day
Time frame: Measured at baseline and Year 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 13 Jun 2012.
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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.
Isabel D. Fernandez, MD, MPH, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Exercise and Environment in people with Obesity and Cardiovascular Diseases, run by University of Rochester at 1 site in United States.
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 1 inclusion and 0 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 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
BMI (time frame: Measured at baseline and Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2012.