An interventional study of weight gain prevention in Obesity, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention
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.
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 1,747 is above the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.
Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.
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Exclusion Criteria:
Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
Behavioral: weight gain prevention
No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
1. 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.
Also known as: worksite intervention, obesity prevention
Change in Body Mass Index (BMI)
Assessed in kilograms per meter squared.
Time frame: Baseline to 24 months
Participants were recruited at worksites between January 2006 and April 2007. Human resources departments provided worksite contact information for all eligible employees; these email addresses and phone numbers were used for recruitment contact purposes.
| Milestone | Worksite Environmental Intervention | No-contact Control |
|---|---|---|
| Started | 752 | 995 |
| Completed | 611 | 795 |
| Not completed | 141 | 200 |
| Withdrew: Lost to follow-up | 18 | 11 |
| Withdrew: Withdrawal by subject | 8 | 9 |
| Withdrew: Left workforce | 115 | 180 |
Assessed in kilograms per meter squared.
| kilograms per meter squared | Worksite Environmental Intervention | No-contact Control |
|---|---|---|
| Change in Body Mass Index (BMI) | 0.315 ± 0.08959 | 0.190 ± 0.07987 |
Collected over Adverse events were tracked for the duration of the study (2 years at each site).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Worksite Environmental Intervention | — | 0/752 (0%) | 0/752 (0%) |
| No-contact Control | — | 0/995 (0%) | 0/995 (0%) |
| Age, Categorical(Participants) | Worksite Environmental Intervention | No-contact Control | Total |
|---|---|---|---|
| <=18 years | 17 | 32 | 49 |
| Between 18 and 65 years | 729 | 954 | 1683 |
| >=65 years | 6 | 9 | 15 |
| Age, Continuous(years) | Worksite Environmental Intervention | No-contact Control | Total |
|---|---|---|---|
| Mean | 42.7 ± 10.8 | 43.1 ± 10.6 | 42.9 ± 10.7 |
| Sex: Female, Male(Participants) | Worksite Environmental Intervention | No-contact Control | Total |
|---|---|---|---|
| Female | 478 | 608 | 1086 |
| Male | 274 | 387 | 661 |
| Region of Enrollment(participants) | Worksite Environmental Intervention | No-contact Control | Total |
|---|---|---|---|
| United States | 752 | 995 | 1747 |
The record gives a start of Jan 2006, a primary completion of Mar 2009 and a completion of Mar 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2013, 4 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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