Clinical trial NCT00481715: Comparison of Two Workplace-Sponsored Obesity Prevention Programs
Official title: Interventions to Control Obesity in Colleges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Web-Based Weight Loss Program
Cash Incentive Weight Loss Program
North Carolina
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-06-04
Enrollment: 1020
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight loss
timeFrame: Measured at Mo 3,6, 12, 18 mo; powered at 12 mo measure
Secondary outcomes:
measure: 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
timeFrame: Measured at Mo 3, 6, 12 and 18 mo
measure: Self-reported health; presenteeism; productivity/work limits; turnover/absenteeism; medical expenditures data; campus changes in the physical/social environment
timeFrame: Measured at Mo 3, 6, 12, 18 mo
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Laura A. Linnan, ScD, CHES
role: PRINCIPAL_INVESTIGATOR
References: