Promoting Activity and Changes in Eating (PACE) to Reduce Obesity
NCT ID: NCT00119782
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3000 participants
INTERVENTIONAL
2004-09-30
2009-11-30
Brief Summary
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Detailed Description
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More than half of American adults are overweight or obese, and this proportion is increasing. The health risks associated with obesity include diabetes, cardiovascular disease, arthritis, and some cancers. It is well established that on an individual level, weight gain is caused by taking in more calories than are expended. On a population basis, the prevalence of overweight and obesity is associated with a myriad of influences, including genetic and physiological factors as well as social, behavioral, cultural, and environmental factors. Behavioral factors that contribute to weight gain include eating choices that lead to increased energy intake and physical activity choices that lead to decreased energy expenditure. For a majority of overweight individuals, restoring the balance between energy intake and expenditure is difficult.
DESIGN NARRATIVE:
This study will develop and test a comprehensive intervention involving simple messages that will integrate changes in dietary intake with changes in energy expenditure, while simultaneously modifying structural and environmental factors to promote social support and opportunities for behavioral change. The study will recruit and randomize 48 worksites to a 2-year intervention in which the following will be carried out: build a physical activity intervention combining increased daily physical activity and regular, structured exercise; build a dietary intervention that will promote lower calorie intake; and increase worksite access to both healthy foods and physical activity. The primary aim is to evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites. The study will compare changes in body mass index in intervention versus control worksites using two cross-sectional surveys at baseline and follow-up. Additional assessments using biomarkers and fitness measures will be performed in a subset of employees. The research team has considerable experience with interventions at the worksite level and substantial expertise in obesity prevention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
Comprehensive worksite intervention
Diet
A dietary intervention that will promote lower calorie intake
Exercise
A physical activity intervention combining increased daily physical activity and regular, structured exercise
Environment
Increase worksite access to both healthy foods and physical activity
2
Delayed intervention control group
Diet
A dietary intervention that will promote lower calorie intake
Exercise
A physical activity intervention combining increased daily physical activity and regular, structured exercise
Environment
Increase worksite access to both healthy foods and physical activity
Interventions
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Diet
A dietary intervention that will promote lower calorie intake
Exercise
A physical activity intervention combining increased daily physical activity and regular, structured exercise
Environment
Increase worksite access to both healthy foods and physical activity
Eligibility Criteria
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Inclusion Criteria
* At least 20% of employees are sedentary
* Willing to provide a list of employees
* Able to achieve at least a 70% response rate to the baseline survey
18 Years
70 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Fred Hutchinson Cancer Research Center
Principal Investigators
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Shirley Beresford
Role: STUDY_CHAIR
Fred Hutchinson Cancer Center
Locations
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Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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193
Identifier Type: -
Identifier Source: org_study_id