ObesityHealthWorksNCT00708461
Environmental Intervention for Weight Gain Prevention
A study testing weight gain prevention in people with Obesity, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- weight gain prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,747 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or older
- generally in good health
- part- or full-time employee in one of the participating worksites
Who cannot join
- work on site <50% of the time
- work second or third shift
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- weight gain prevention
- Keywords
- obesity, obesity prevention, worksite, environment, intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight gain preventionBehavioural
Also called worksite intervention, obesity prevention
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Worksite Environmental Intervention | Experimental | Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention Receives: Behavioral: weight gain prevention |
| No-contact control | No intervention | No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
Assessed in kilograms per meter squared.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJan 2006
- Primary completionMar 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 1,747 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert W Jeffery, PhD, Principal investigator, University of Minnesota, Division of Epidemiology and Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708461
- Sponsor's protocol ID
- 0408S62609
- Other IDs
- 5R01DK067362
- Acronym
- HealthWorks
- Status last verified
- Oct 2019
- First submitted
- 27 Jun 2008
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23108493Linde 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.
PubMed 22340088VanWormer 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.
PubMed 21952267VanWormer 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.
PubMed 21732212Graham 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.
PubMed 23979097
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
- Environmental Intervention for Weight Gain Prevention
- ClinicalTrials.gov ID
- NCT00708461
- Acronym / sponsor ID
- HealthWorks / 0408S62609
- Conditions
- Obesity
- Keywords
- obesity, obesity prevention, worksite, environment, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,747 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Posted 18 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Worksite Environmental Intervention | Experimental | Behavioral: weight gain preventionChanges to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention |
| No-contact control | No intervention | –No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 or older
- generally in good health
- part- or full-time employee in one of the participating worksites
Key exclusion criteria (2 listed)
- work on site <50% of the time
- work second or third shift
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 |
|---|---|---|
| weight gain preventionAlso: worksite intervention, obesity prevention1. 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. 2. 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. 3. Changes to the environment to increase cues and incentives for regular weight monitoring by providing scales at convenient locations. 4. Changes in the informational environment that increase frequency of exposure of the employee population to accurate information about healthy food and activity choices. | Behavioural | Worksite Environmental Intervention |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: Baseline to 24 months
Assessed in kilograms per meter squared.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23108493VanWormer 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 publication: PubMed 22340088Linde 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 publication: PubMed 21952267VanWormer 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 publication: PubMed 21732212VanWormer 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.
- Derived from this study: PubMed 23979097Graham 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.
- HealthWorks is a study housed in the University of Minnesota Obesity Prevention Center.Link provided by the sponsor.
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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.
Robert W Jeffery, PhD principal investigator
University of Minnesota, Division of Epidemiology and Community Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight gain prevention in people with Obesity, 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 3 inclusion and 2 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?
Yes. Results are posted in the registry (first posted 18 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Mass Index (BMI) (time frame: Baseline to 24 months). 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 NCT00708461, which also lists 5 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 1 Nov 2019.