- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119782
Promoting Activity and Changes in Eating (PACE) to Reduce Obesity (PACE)
Reducing Obesity at the Workplace: a Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND:
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 91809-1024
- Fred Hutchinson Cancer Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The study is enrolling employees only at participating worksites.
INCLUSION CRITERIA FOR WORK SITES:
- Meets specific standard industrial codes
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Comprehensive worksite intervention
|
A dietary intervention that will promote lower calorie intake
A physical activity intervention combining increased daily physical activity and regular, structured exercise
Increase worksite access to both healthy foods and physical activity
|
Experimental: 2
Delayed intervention control group
|
A dietary intervention that will promote lower calorie intake
A physical activity intervention combining increased daily physical activity and regular, structured exercise
Increase worksite access to both healthy foods and physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body mass index
Time Frame: Measured at Month 24 follow-up visit; adjusted for baseline body mass index
|
Measured at Month 24 follow-up visit; adjusted for baseline body mass index
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-reported dietary and physical activity behaviors
Time Frame: Measured at Month 24 follow-up visit
|
Measured at Month 24 follow-up visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Shirley Beresford, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 193
- R01HL079491 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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