- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00481715
Comparison of Two Workplace-Sponsored Obesity Prevention Programs
Interventions to Control Obesity in Colleges
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity, which leads to higher rates of diabetes, cancer, and heart disease, is an increasingly important public health problem. Evidence suggests that the effects of poor diet and physical inactivity will soon overtake smoking as the leading cause of death. Obesity-attributable medical expenses account for 9.1% of the total annual medical expenditures in the United States, and may be as high as $78.5 billion. In North Carolina, obesity accounts for more than $2 billion annually in increased medical spending and nearly half of this total is financed through employer-provided health insurance. Weight loss programs that take place at work have demonstrated the ability to improve both employee health and the financial health of the company. However, few weight loss programs have been evaluated and implemented in the workplace. The purpose of this study is to compare the effectiveness of a Web-based weight loss program versus a cash incentive weight loss program among employees at universities and colleges in North Carolina.
This study will enroll approximately 1200 employees from 12 universities and colleges in North Carolina. Each university or college will be randomly assigned to one of the following four groups: 1) a Web-based weight loss program, 2) a cash incentive weight loss program, 3) the Web-based program plus the cash incentive program, or 4) neither program. Participants in the Web-based weight loss program will take part in a weekly Web-based weight control program that is comprehensive, individually focused, self-directed, and includes both weight loss and weight gain prevention information. In the cash incentive program, participants will receive a cash payment if they lose a pre-determined amount of weight at each follow-up weigh in. At baseline and Months 3, 6, 12, and 18, all participants will be weighed, body fat measurements will occur, and information on physical activity levels, eating behaviors, quality of life, work productivity, and medical expenses will be collected. During this study, study researchers will also monitor changes that occur in the physical and social environment on campus.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (BMI) greater than or equal to 25
- Current FT employee and member of the State Health Plan in North Carolina
Exclusion Criteria:
- Pregnant or breastfeeding
- Type 1 diabetes
- Currently taking weight loss medication
- Lacks internet access at work or home
- Previous weight loss surgery or plans to have weight loss surgery
- Answers "Yes" to any of the Physical Activity Readiness Questionnaire questions
- Known history of stroke, coronary heart disease, or type 2 diabetes, or possesses a BMI of 42 or higher AND does not have a medical clearance from a physician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Web-based weight loss program
|
Participants will take part in a Web-based weight loss program.
|
Experimental: 2
Cash incentive weight loss program
|
Participants will take part in a cash incentive weight loss program.
|
Experimental: 3
Web-based program plus the cash incentive program
|
Participants will take part in a Web-based weight loss program.
Participants will take part in a cash incentive weight loss program.
|
No Intervention: 4
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight loss
Time Frame: Measured at Mo 3,6, 12, 18 mo; powered at 12 mo measure
|
Measured at Mo 3,6, 12, 18 mo; powered at 12 mo measure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of body fat; moderate physical activity (PA); moderate/vigorous PA and step counts; total calories consumed; fruits and vegetables consumed; total and saturated fat consumed; overall eating behavior; health related quality of life
Time Frame: Measured at Mo 3, 6, 12 and 18 mo
|
Measured at Mo 3, 6, 12 and 18 mo
|
Self-reported health; presenteeism; productivity/work limits; turnover/absenteeism; medical expenditures data; campus changes in the physical/social environment
Time Frame: Measured at Mo 3, 6, 12, 18 mo
|
Measured at Mo 3, 6, 12, 18 mo
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Laura A. Linnan, ScD, CHES, University of North Carolina, Chapel Hill
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
- 473
- R01HL080656-01A1 (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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