Comparison of Two Workplace-Sponsored Obesity Prevention Programs

NCT ID: NCT00481715

Last Updated: 2011-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1020 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Web-based weight loss program

Group Type: EXPERIMENTAL

Web-Based Weight Loss Program

Intervention Type: BEHAVIORAL

Participants will take part in a Web-based weight loss program.

2

Cash incentive weight loss program

Group Type: EXPERIMENTAL

Cash Incentive Weight Loss Program

Intervention Type: BEHAVIORAL

Participants will take part in a cash incentive weight loss program.

3

Web-based program plus the cash incentive program

Group Type: EXPERIMENTAL

Web-Based Weight Loss Program

Intervention Type: BEHAVIORAL

Participants will take part in a Web-based weight loss program.

Cash Incentive Weight Loss Program

Intervention Type: BEHAVIORAL

Participants will take part in a cash incentive weight loss program.

4

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Web-Based Weight Loss Program

Participants will take part in a Web-based weight loss program.

Intervention Type: BEHAVIORAL

Cash Incentive Weight Loss Program

Participants will take part in a cash incentive weight loss program.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

UNC Chapel Hill

Principal Investigators

Laura A. Linnan, ScD, CHES

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Other Identifiers

R01HL080656-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

473

Identifier Type: -

Identifier Source: org_study_id