ObesityNCT00122993
Worksite Program to Prevent Weight Gain Among Bus Drivers
A study testing Healthful eating and food choices behavior change programs and changes in worksite food availability and prices, Physical Activity and Environment in people with Obesity and Cardiovascular Diseases, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to implement and evaluate a two-year multi-component environmental intervention to prevent weight gain among city bus drivers at four bus garages. It is hypothesized that transit employees in the intervention garages will gain less weight compared to the transit employees in the control… 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?
- Healthful eating and food choices behavior change programs and changes in worksite food availability and prices, Physical Activity and Environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Apr 2008
- 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
- Employed as a bus driver
Who cannot join
- Not employed as a bus operator at one of the four participating garages
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Worksite Environmental Interventions for Weight Control
The purpose of this study is to implement and evaluate a two-year multi-component environmental intervention to prevent weight gain among city bus drivers at four bus garages.
It is hypothesized that transit employees in the intervention garages will gain less weight compared to the transit employees in the control garages.
Read the detailed description
BACKGROUND:
Environmental influences that support less healthful food choices and sedentary behaviors have contributed to the epidemic increase in overweight and obesity among U.S. adults. Worksite settings are an effective channel through which to reach adults with interventions designed to prevent excess weight gain and obesity.
DESIGN NARRATIVE:
This study will implement and evaluate a multi-component environmental intervention to prevent excess weight gain among 1200 bus drivers working in four garages in a major metropolitan area. Four garages will be randomized to the intervention or control group for a two-year period. The environmental interventions are based on a social ecological framework and target four worksite environmental areas: 1) food availability and incentives; 2) physical activity opportunities and incentives; 3) the social environment; and 4) media/promotion related to health food choices, physical activity, and body weight.
- Conditions
- Obesity, Cardiovascular Diseases, Heart Diseases
- Being tested
- Healthful eating and food choices behavior change programs and changes in worksite food availability and prices, Physical Activity, Environment
- 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.
Healthful eating and food choices behavior change programs and changes in worksite food availability and pricesBehavioural
Food choices and eating behavior programs and environmental changes will be implemented for 18 months in intervention garages.
Physical ActivityBehavioural
Physical activity programs are offered at the intervention garages for an 18 month period.
EnvironmentBehavioural
Changes in the food and physical activity environment are made for an 18 month period in intervention garages. These include improving the healthfulness of the foods available in vending machines, and improving the fitness rooms at the garages.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Multi-component environmental intervention to prevent excess weight gain among bus drivers Receives: Behavioral: Healthful eating and food choices behavior change programs and changes in worksite food availability and prices; Behavioral: Physical Activity; Behavioral: Environment |
| 2 | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Measured at Year 2
Secondary outcomes (2)
Changes in energy intake and physical activity
Measured: Measured at Year 2
Health claims cost
Measured: Measured at Year 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 startSep 2004
- Primary completionDec 2007
- Study completionApr 2008
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.
- More trials run by University of MinnesotaThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Simone French, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122993
- Sponsor's protocol ID
- 0409S63606
- Other IDs
- R01HL079478
- Status last verified
- Oct 2019
- First submitted
- 20 Jul 2005
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worksite Environmental Interventions for Weight Control
- ClinicalTrials.gov ID
- NCT00122993
- Acronym / sponsor ID
- 0409S63606
- Conditions
- Obesity, Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (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 implement and evaluate a two-year multi-component environmental intervention to prevent weight gain among city bus drivers at four bus garages.
It is hypothesized that transit employees in the intervention garages will gain less weight compared to the transit employees in the control garages.
Detailed description
BACKGROUND:
Environmental influences that support less healthful food choices and sedentary behaviors have contributed to the epidemic increase in overweight and obesity among U.S. adults. Worksite settings are an effective channel through which to reach adults with interventions designed to prevent excess weight gain and obesity.
DESIGN NARRATIVE:
This study will implement and evaluate a multi-component environmental intervention to prevent excess weight gain among 1200 bus drivers working in four garages in a major metropolitan area. Four garages will be randomized to the intervention or control group for a two-year period. The environmental interventions are based on a social ecological framework and target four worksite environmental areas: 1) food availability and incentives; 2) physical activity opportunities and incentives; 3) the social environment; and 4) media/promotion related to health food choices, physical activity, and body weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Healthful eating and food choices behavior change programs and changes in worksite food availability and prices, Behavioral: Physical Activity, Behavioral: EnvironmentMulti-component environmental intervention to prevent excess weight gain among bus drivers |
| 2 | No intervention | –Control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employed as a bus driver
Key exclusion criteria (1 listed)
- Not employed as a bus operator at one of the four participating garages
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 |
|---|---|---|
| Healthful eating and food choices behavior change programs and changes in worksite food availability and pricesFood choices and eating behavior programs and environmental changes will be implemented for 18 months in intervention garages. | Behavioural | 1 |
| Physical ActivityPhysical activity programs are offered at the intervention garages for an 18 month period. | Behavioural | 1 |
| EnvironmentChanges in the food and physical activity environment are made for an 18 month period in intervention garages. These include improving the healthfulness of the foods available in vending machines, and improving the fitness rooms at the garages. | Behavioural | 1 |
Primary outcome
Change in body weight
Time frame: Measured at Year 2
2 secondary outcomes
Changes in energy intake and physical activity
Time frame: Measured at Year 2
Health claims cost
Time frame: Measured at 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 1 Nov 2019.
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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.
Simone French principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthful eating and food choices behavior change programs and changes in worksite food availability and prices, Physical Activity and Environment in people with Obesity and Cardiovascular Diseases, run by University of Minnesota 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 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 1 Nov 2019. 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?
Change in body weight (time frame: Measured at 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 1 Nov 2019.