Comparison of Two Workplace-Sponsored Obesity Prevention Programs
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-Based Weight Loss Program
Cash Incentive Weight Loss Program
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring Web-Based Weight Loss Program, Cash Incentive Weight Loss Program, North Carolina
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
1
2
3
4
Arm Description
Web-based weight loss program
Cash incentive weight loss program
Web-based program plus the cash incentive program
No intervention
Outcomes
Primary Outcome Measures
Weight loss
Secondary Outcome Measures
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
Self-reported health; presenteeism; productivity/work limits; turnover/absenteeism; medical expenditures data; campus changes in the physical/social environment
Full Information
NCT ID
NCT00481715
First Posted
May 31, 2007
Last Updated
January 26, 2011
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00481715
Brief Title
Comparison of Two Workplace-Sponsored Obesity Prevention Programs
Official Title
Interventions to Control Obesity in Colleges
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Obesity has reached epidemic proportions in the United States with nearly 64% of American adults considered overweight or obese. Weight loss programs that take place at work have proven to be effective at promoting healthy lifestyles. 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 North Carolina universities and colleges.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Web-Based Weight Loss Program, Cash Incentive Weight Loss Program, North Carolina
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1020 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Web-based weight loss program
Arm Title
2
Arm Type
Experimental
Arm Description
Cash incentive weight loss program
Arm Title
3
Arm Type
Experimental
Arm Description
Web-based program plus the cash incentive program
Arm Title
4
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Web-Based Weight Loss Program
Intervention Description
Participants will take part in a Web-based weight loss program.
Intervention Type
Behavioral
Intervention Name(s)
Cash Incentive Weight Loss Program
Intervention Description
Participants will take part in a cash incentive weight loss program.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
Measured at Mo 3,6, 12, 18 mo; powered at 12 mo measure
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A. Linnan, ScD, CHES
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Workplace-Sponsored Obesity Prevention Programs
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